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Powerful Medical granted CPT code for AI ECG heart attack detection, weeks after FDA De Novo authorization of Queen of Hearts™
Category III code 1139T becomes effective January 1, 2027, giving U.S. physicians and hospitals a dedicated procedure code to report AI ECG analysis for heart attacks.
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Little Sparrows Technologies receives Innovative Technology designation from Vizient for bili-hut™ neonatal phototherapy
The Vizient designation recognizes Vizient-contracted products that bring improvement to the healthcare industry.
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Altrazeal outperforms standard-of-care dressings in interim Phase IV burn trial results
Interim results from a Phase IV randomized controlled trial in partial-thickness burns, presented at SAWC Fall 2026, showed Altrazeal significantly outperformed standard-of-care dressings.
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MiWEndo Solutions completes final patient procedure in the MiWEndo II clinical study
MiWEndo Solutions has completed the final patient procedure of its MiWEndo II clinical study of microwave-based sensing technology for colonoscopy.
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Australian medtech company receives prestigious award nomination featuring OncoRes Medical
OncoRes Medical has been nominated for the 2026 Prix Galien USA Awards in the Best Startup category.
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CorWave completes enrollment in feasibility study and presents first clinical data on adaptive support with its wave membrane LVAD
CorWave has completed enrollment in its feasibility study of the CorWave LVAS and presented the first clinical data on the device’s adaptive control algorithm.
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Eko Health launches CORE 300™ to bring AI-enabled stethoscopes to every healthcare professional
Eko Health announces FDA 510(k) clearance of CORE 300 for use in pediatric and adult patients.
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Nutromics shares world-first real-time creatinine data at American Society of Nephrology’s Kidney Week
Nutromics has presented world-first, real-time measurements of creatinine in humans using DNA-based sensors at ASN Kidney Week 2026.
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FDA grants 510(k) clearance for BoneEnhance, the first machine learning layer on RIVANNA’s Accuro XV platform
Anatomy segmentation and three-dimensional skeletal visualization arrive with this clearance; an injury detection module for clinical decision support is in development on the platform roadmap.
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Noah Labs enrolls first patients in VOICE-HF, the pivotal trial to support FDA authorization of its voice-based AI to detect worsening heart failure
The prospective, multicenter trial is enrolling approximately 450 patients to evaluate Noah Labs Vox™, an investigational software medical device designed to detect worsening heart failure from a short daily voice recording.
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Osteoboost report highlights awareness gap in women’s bone health
Osteoboost has released findings from “The Menopause Bone Health Gap,” an independent research study highlighting gaps in bone loss prevention and treatment awareness.
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MIT spinout makes surgical stitching more like applying a sticky note featuring SanaHeal
SanaHeal has developed a biologically compatible adhesive that sticks to wet tissues to simplify a variety of surgeries.
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AccurKardia named a finalist in the Digital Health Hub Foundation Digital Health & AI Awards 2026
AccurKardia has been named a finalist in the Digital Health Hub Foundation’s Digital Health & AI Awards 2026 at HLTH.
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Universal Brain announces first clinical deployment of FDA-cleared brain function measurement system at Acacia Clinics
The collaboration brings objective brain-function measurement into clinical practice at a Silicon Valley precision psychiatry provider specializing in neuromodulation for treatment-resistant depression and related conditions.
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Butterfly Medical achieves EU MDR certification for next-generation BPH treatment
The milestone demonstrates compliance with rigorous European regulatory standards for medical device safety and performance.
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Total Flow Medical named as a Finalist for the EACTS - European Association for Cardio-Thoracic Surgery Innovation Award
Total Flow Medical was named a finalist for the EACTS Innovation Award in Barcelona as it prepares for early commercial use following FDA 510(k) clearance.
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Inflammatix Selected for ARPA-H CIRCLE Program to Bring Precision Immune Medicine to the ICU
Company will develop the bedside immune-state readout for a Stanford Medicine–led team awarded $41 million in ARPA-H’s CIRCLE critical care program.
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Vektor Medical Announces AMA CPT Editorial Panel Approval of New Category I CPT Code for Non-Invasive Ventricular Arrhythmia Localization
New milestone recognizes non-invasive arrhythmia localization as an established medical service and advances the reimbursement pathway for vMap®.
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Newrotex selected as a finalist for the “Art of Medical Innovation Award”
Newrotex has been selected as a finalist for the Art of Medical Innovation Award at the Oxford Saïd Business School.
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Sonorous Neurovascular Receives FDA IDE Approval for First U.S. Pivotal Trial of a Venous Sinus Stent to Treat Pulsatile Tinnitus
B-SILENT 2 adds a U.S. pivotal study to the company's international clinical program and advances its cerebral venous disease platform.
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InkSpace Imaging receives FDA 510(k) clearance for the newest MRI receive coil for Philips 1.5T MRI systems
InkSpace Imaging has received FDA 510(k) clearance for its newest flexible, high-density MRI receive coil for Philips 1.5T MRI systems.
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LEADOPTIK begins RISE clinical study at Stanford Medicine to evaluate real-time lung biopsy guidance
LEADOPTIK performed its first cases at Stanford Medicine, starting RISE, a clinical study of the LIA™ platform in peripheral lung biopsy.
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Axoft named one of Fast Company's Next Big Things in Tech
Axoft has been named one of Fast Company's Next Big Things in Tech for its implantable brain-computer interfaces.
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OXOS Medical Awarded BARDA Contract Worth Up to $24 Million to Develop X3 Ultra-Portable X-ray Imaging System
Contract supports development and U.S. FDA clearance of the OXOS X3, an ultra-portable X-ray system for emergency departments, clinics and field settings.
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Mayo-trained doctor wins top Minnesota Cup prize for aneurysm surgery tool featuring Octin Health
The Minnesota Star Tribune profiles Octin Health founder Dr. Meghana Helder, whose Elika aortic surgery device won the 2026 Minnesota Cup grand prize.
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Innova Vascular's Laguna® Thrombectomy System Surpasses Primary Endpoints in Pivotal TRUST Study for Pulmonary Embolism
Innova Vascular announced positive results from its pivotal TRUST study evaluating the Laguna® Thrombectomy System for the treatment of pulmonary embolism.
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Zenflow Secures $52M Series D Financing and Announces Exclusive U.S. Distribution Partnership with Cook Medical
Series D proceeds to support commercialization of the Zenflow Spring® System for Men with Enlarged Prostate.
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Winter Innovations Awarded $500K Phase IIB SBIR Grant from National Science Foundation to Accelerate Commercialization of EasyWhip®
Winter Innovations has been awarded a $500,000 Phase IIB SBIR grant from the U.S. National Science Foundation, bringing its total NSF funding to nearly $2 million.
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Terumo Neuro signs agreement to acquire Arsenal Medical, advancing next-generation liquid embolic innovation for treating chronic subdural hematoma (cSDH)
Terumo Neuro has signed an agreement to acquire Arsenal Medical, developer of the NeoCast™ liquid embolic for chronic subdural hematoma.
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52North raises £3.2 million to transform urgent cancer care, with funding co-led by Macmillan Cancer Support and Hargreave Hale AIM VCT
52North, the University of Cambridge spin-out behind the Aster™ biomarker platform, has secured £3.2 million in new funding to accelerate its mission to help transform urgent cancer care and bring its core product, Neutrocheck® to market.
Arsenal Medical awarded a $4M NIH CRP grant to advance the clinical development of NeoCast
Arsenal Medical has been awarded a $4M NIH CRP grant to advance the clinical development of NeoCast and strengthen the evidence base for next-generation liquid embolics.
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Knowtex, the first frontier AI lab for healthcare, named prime awardee on VA's nine-figure Ambient Scribe Enterprise contract
Knowtex, the first frontier AI lab for healthcare, announced today that the U.S. Department of Veterans Affairs (VA) has selected it as a prime awardee on the Ambient Scribe Enterprise Indefinite Delivery, Indefinite Quantity (IDIQ) contract.
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Biolinq Shine™ receives FDA 510(k) clearance for over-the-counter use
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for over-the-counter (OTC) use of Biolinq Shine™, Biolinq's needle-free glucose sensor, expanding access to the device without a prescription.
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GenAssist selected as one of the winners of the SPARK for Innovations in Pediatrics Hub Pediatric Medical Countermeasures Summit pitch competition
GenAssist took part in the SPARK for Innovations in Pediatrics Hub Pediatric Medical Countermeasures Summit and was selected as one of the winners of its pitch competition.
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Encellin partners with Breakthrough T1D to advance ENCRT-103-hPI into the clinic and build on the results of their first-in-human study
Encellin has partnered with Breakthrough T1D to advance ENCRT-103-hPI, the next generation of its encapsulated cell replacement therapy for Type 1 Diabetes, into the clinic.
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Adaptyx Biosciences granted FDA breakthrough device designation for its continuous cortisol monitoring technology and is accepted into FDA’s Total Product Life Cycle Advisory Program
The FDA has granted Breakthrough Device Designation to Adaptyx Biosciences' continuous cortisol monitoring device, and the company has been accepted into the FDA's Total Product Life Cycle Advisory Program (TAP).
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UltraSight raises $24 million to scale its AI-guided cardiac workflow platform across U.S. health systems
Financing builds on FDA clearances, clinical evidence and commercial traction to advance the UltraSight Echosystem and broaden cardiovascular partnerships.
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Teal Health raises $22 million series A to expand access to the most accurate FDA-authorized at-home HPV cervical cancer screening
Round led by .406 Ventures fuels Teal Health’s next phase of growth, expanding payor, health system, employer and provider partnerships ahead of broad insurance coverage in 2027.
RIVANNA crosses 100-patent threshold: estate protects shared platform spanning multiple FDA-cleared product lines
100+ patents across 20+ families, accelerating at 30% year-over-year growth.
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Avenda Health expands private practice network with the deployment of Unfold AI at Arizona Urology, bringing AI prostate cancer mapping to the southwest
Leading Phoenix urology practice adopts advanced AI cancer mapping to personalize surgical planning, enhance patient visualization, and pave the way for outpatient treatments.
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Prapela announces exclusive global distribution agreement with GE Healthcare
Prapela has announced an exclusive global distribution agreement with GE HealthCare for its therapeutic vibrational mattress pad.
RIVANNA announces new CMS procedure code for computer-aided neuraxial guidance
Effective October 1, 2026, ICD-10-PCS code XEZU3HC establishes the first dedicated national inpatient coding category for real-time ultrasound navigation with continuous needle tracking.
Octin Health named the 2026 Minnesota Cup Grand Prize winner
Octin Health has been named the 2026 Minnesota Cup Grand Prize winner, receiving $76,000 for its Elika Device.
AI medtech’s real test begins after FDA clearance featuring Avenda Health
In an interview with MedTech Spectrum, Avenda Health co-founder and COO Brittany Berry, Ph.D., shares lessons from the commercialisation of Unfold AI.
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Peerbridge Health receives FDA clearance for Cor MDx, the platform built for the future of cardiac care
The wearable is built to capture the signal fidelity that cardiac care demands, from hospital discharge through recovery at home and follow-up in clinic.
The National Cancer Institute has awarded LEADOPTIK a $1.85M SBIR Phase II grant
The National Cancer Institute has awarded LEADOPTIK a $1.85M SBIR Phase II grant to support OPTIC, a multicenter clinical study of the LIA™ platform.
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Multi4 Medical publishes landmark clinical study in prestigious BJUI – initiates first patient treatments in Europe
First-in-human study in British Journal of Urology International confirms bladder cancer treatment can shift from the operating room to the outpatient clinic.
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Access Vascular receives Innovative Technology contract from Vizient for HydroMID® midline catheter
Access Vascular’s HydroMID® midline catheter has received an Innovative Technology contract from Vizient®, the nation’s largest provider-driven healthcare performance improvement company.
Nutromics receives FDA Breakthrough Device Designation
The FDA has granted Breakthrough Device Designation to Nutromics’ first product in development, a wearable lab-on-a-patch™ for vancomycin therapeutic drug monitoring.
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Baltimore’s Nanochon treats first patient in Chondrograft™’s first-in-human trial
Nanochon has treated the first patient in the First-in-Human clinical study for Chondrograft™, its 3D-printed implant for knee cartilage repair.
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Panda Surgical awarded Innovate UK funding to develop an AI co-pilot for robotic neurosurgery
Panda Surgical has been awarded £377,967 by Innovate UK as part of the Biomedical Catalyst to develop an AI co-pilot for robotic neurosurgery with UCLH.
Zenflow announces U.S. commercialization progress with four centers completing Zenflow Spring® Implant and Delivery System Procedures
Zenflow has announced the first commercial procedures with the Zenflow Spring® Implant and Delivery System for the treatment of symptoms associated with benign prostatic hyperplasia (BPH).
Powerful Medical’s AI heart attack detection model secures FDA approval
The FDA has granted De Novo authorisation to Powerful Medical’s Queen of Hearts, an AI model that detects acute coronary syndrome from ECG analysis.
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Society of Robotic Surgery and Puma Venture Capital announce winners of SRS Shark Tank 2026 featuring Drive Medical
Drive Medical claimed the top prize at the third annual SRS Shark Tank 2026, held during the Society of Robotic Surgery’s annual conference.
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Cohesys has been selected into the NATO DIANA 2026 Mission Track Cohort
Cohesys has been selected for the NATO DIANA 2026 Mission Track Cohort, one of two Canadian companies chosen this year.
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Flux Robotics announces OEM partnership with Nano4Imaging
Flux Robotics has partnered with Nano4Imaging as the OEM partner for its AXIOM steerable magnetic guidewire, with Fraunhofer IPT supporting manufacturing process development.
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Flosonics Medical partners with BARDA to develop AI-enabled trauma capability for FloPatch
The contract, valued at up to $70 million, supports FloPredict, software designed to help clinicians identify patients at risk from internal hemorrhage.
Innova Vascular completes enrollment in Trust IDE study evaluating the Laguna Thrombectomy System for pulmonary embolism
Innova Vascular has completed patient enrollment in the TRUST pivotal IDE study evaluating the Laguna® Thrombectomy System for the treatment of pulmonary embolism.
Octin Health is Life Science/Health IT division winner of the Minnesota Cup
Octin Health has been named the Life Science/Health IT Division winner of the 2026 Minnesota Cup.
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Liquet selected as a finalist for Startup of the Year by the Richmond Technology Council
Liquet Medical has been selected as a finalist for Startup of the Year by the Richmond Technology Council.
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NeuroBionics awarded NSF phase II SBIR grant to advance IO Fiber platform
NeuroBionics has been awarded a Phase II SBIR grant from the National Science Foundation to advance its IO Fiber platform, a multifunctional neural probe for neuroscience research.
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STENTiT shares two new preclinical studies on its Resorbable Fibrillated Scaffold
STENTiT has published two new preclinical studies on how its Resorbable Fibrillated Scaffold (RFS) interacts with the vessel after implantation.
FDA READI-Home Innovation Challenge: reducing readmissions through device innovation for the home featuring Prapela
Prapela has been selected by the FDA to advance to the interaction phase of the READI-Home Innovation Challenge with its Therapeutic Vibrational Crib Mattress.
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The cancer that kills more women than breast and ovarian combined gets a new tool featuring Prana Surgical
Forbes profiles Houston-based Prana Surgical and its FDA-cleared Prana System, dubbed “the lumpectomy of the lung.”
American Medical Association: How to make the most of patients’ wearable data featuring Eko Health
Eko Health’s Chief Medical Officer, Steven Steinhubl, MD, is featured in an American Medical Association piece on making wearable data usable in routine care.
Why bone health Is preventive healthcare’s next big category featuring Osteoboost Health
In a column for MedCity News, Osteoboost Health CEO Laura Yecies discusses bone health.
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FDA authorizes first-of-its-kind robotic blood draw device featuring Vitestro
Authorization supports innovative approach to blood collection; may help address growing phlebotomist shortage.
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Renata Medical closes $25M series D financing led by global healthcare investment firm ARCHIMED to accelerate commercialization and development of pediatric cardiovascular technologies
Renata Medical has closed a $25 million Series D financing round led by ARCHIMED to expand commercialization of its Minima™ Stent System and advance its pediatric pipeline.
Nanochon receives regulatory approval from Panamá's Ministry of Health to initiate first-in-human clinical study of Chondrograft™
Nanochon has received regulatory approval from Panamá's Ministry of Health to initiate its First-in-Human clinical study of Chondrograft™ in Panamá.
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Olympus announces global distribution agreement with Endocision for respiratory cryobiopsy system
Olympus has announced an exclusive global distribution agreement with Endocision for its portable, single-use flexible cryocatheter system.
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Samay named to the 2026 Colombia Early Stage 100 by NuMundo Ventures
Samay is developing Sylvee, an AI-powered wearable designed to detect COPD before spirometry can, enabling earlier and more accessible respiratory disease detection for the millions of people who need it.
First-in-Human Trial of NeoCast, Arsenal Medical's Liquid Embolic Biomaterial
NeoCast is a solvent-free, non-adhesive biomaterial engineered to achieve microvascular occlusion. EMBO-01 is the first-in-human trial of NeoCast for the pre-surgical embolization of hypervascular brain tumors.
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Hamilton company acquires Charlottesville-based UVA spin-off company Cerillo
Hamilton Company, a global life sciences and laboratory technology company, has acquired Charlottesville-based, University of Virginia spin-off company Cerillo.
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Laura Yecies, CEO of Osteoboost Health, named to Forbes’ Women 50 Over 50 list in the Innovation category
One in every two women over the age of 50 will break a bone due to osteoporosis, but Laura Yecies is working to reduce that risk. As the CEO of Osteoboost, Yecies oversees a company making the first FDA-cleared wearable device shown to slow bone loss in postmenopausal women with osteopenia.
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How VB Spine is building an AR ecosystem featuring Augmedics
VB Spine’s co-CEO and global president discuss how CT-Fluoro technology, augmented reality navigation, and family ownership are shaping the company’s strategy in a consolidating market.
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Knowtex Publishes White Paper on National VA Deployment of Ambient AI
New white paper details how Knowtex's ambient clinical intelligence platform was integrated into VA's CPRS and scaled from a single site to nationwide primary care.
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Haptics is a must-have, this remote robotics developer says featuring Dopl Technologies
Dopl Technologies co-founder and CEO Ryan James tells Medical Design & Outsourcing why haptics matter for remote ultrasound teleprocedures.
OncoRes Medical featured in the latest Winter edition of Uniview
OncoRes Medical is featured in the latest Winter edition of Uniview, where its article explores how its intraoperative imaging technology is being developed to help surgeons better distinguish cancerous from healthy tissue during breast-conserving surgery, with the goal of reducing repeat surgeries and improving outcomes for patients.
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Magnendo Awarded Up to $32M by ARPA-H to Advance Autonomous Robotic Stroke Intervention
Magnendo Corp., an MIT spinout developing magnetic robotic navigation technology for endovascular intervention, has been selected for an award of up to $32 million from ARPA-H under its Autonomous Interventions and Robotics (AIR) program.
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Class Medical receives FDA 510(k) clearance for the TransUrethral Catheter Safety Valve
Class Medical Limited today announced that the United States Food and Drug Administration has granted 510(k) clearance (K260919) for the TransUrethral Catheter Safety Valve (TUCSV), clearing the device for marketing in the United States for use in adult patients.
Vektor democratizes cardiac ablations: vanguards of health care
“We started using AI to enhance algorithms and software to better be able to understand the data that’s in each patient’s ECG. And our goal with that was to bring forward personalized medicine in arrhythmia therapy and improve patient outcomes.”
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Philips Expands Open Monitoring Ecosystem, Adding Caretaker Medical
Royal Philips announced new collaborations with Caretaker Medical and others, expanding its open monitoring ecosystem to support connected patient monitoring from hospital to home.
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Reach Neuro welcomes Jennifer Ernst as Chief Executive Officer
Reach Neuro has named Jennifer Ernst, former CEO of Tivic Health, as its new Chief Executive Officer.
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The story behind Akeyna
On the AuxTalks podcast, Akeyna CEO & Co-Founder Karen Cronholm shares her journey from life sciences executive to startup founder.
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Medasense Biometrics receives Innovative Technology contract from Vizient® for PMD-200™ with NOL technology
Medasense Biometrics announced today that its PMD-200™ pain response (nociception) monitoring system with NOL technology has received an Innovative Technology contract from Vizient®, the largest provider-driven healthcare performance improvement company in the U.S.
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Non-invasive hemodynamic monitoring for babies and children in ICU featuring AcQumen Medical
On today’s episode we speak with Dori Jones , Co-Founder and CEO of AcQumen Medical — a company on a mission to close one of pediatric critical care’s most glaring gaps: the lack of real-time, non-invasive hemodynamic monitoring for babies and children in the ICU.
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Henry Ford, MSU Innovation Fund backs 2 health tech startups featuring LightHearted AI
Henry Ford Health and Michigan State University Health Sciences made the first investments from the Henry Ford + MSU Innovation Fund, backing early-stage companies LightHearted AI and M3D.
Total Flow Medical receives FDA clearance for innovative Femoral Arterial Cannula for cardiopulmonary bypass
The TFA Cannula incorporates a distal balloon feature designed to allow blood flow to the cannulated limb during cardiopulmonary bypass
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Regenyx Medical granted new U.S. Patent further strengthening the IP foundation of the company’s proprietary self-assembling peptide hydrogel platform
This patent further strengthens the IP foundation of Regenyx‘s proprietary self-assembling peptide hydrogel platform, protecting applications across regenerative and aesthetic medicine, including Lipogenyx™ and future applications.
From risk to retention: using wearable hyperkalemia monitoring to sustain GDMT by Moin Hussaini, Chief Product Officer at AccurKardia
In this compelling discussion, Moin Hussaini, Chief Product Officer at AccurKardia, explores how wearable technologies and artificial intelligence are transforming the management of hyperkalemia and helping clinicians sustain Guideline-Directed Medical Therapy (GDMT) for patients with cardiovascular disease.
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LifeBridge Health deploys Prenosis’ FDA-authorized AI tool to speed sepsis detection
LifeBridge Health’s Sinai Hospital of Baltimore is putting an artificial intelligence-powered diagnostic for sepsis into clinical use, bringing a research-backed tool to the patients’ bedside.
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Epitel Secures $26 Million Series B to Expand Remote Wireless EEG Monitoring
Funding will drive commercial expansion of the first fully wireless FDA-cleared EEG system, making AI-driven remote brain monitoring more widely available to patients and providers.
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Aqua Medical Treats First U.S. Patient for Type 2 Diabetes at UNC Health Using Investigational Through-The-Scope Endoscopic Therapy
Aqua Medical, Inc., a clinical-stage medical technology company pioneering Endoscopic Metabolic Restoration, today announced the successful treatment of the first U.S. patient in its U.S. Food and Drug Administration (FDA)-authorized Investigational Device Exemption (IDE) clinical trial evaluating the company’s proprietary Proximal Intestinal Mucosal Ablation (PIMA) procedure for the treatment of type 2 diabetes.
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EvoEndo® expands access to sedation-free endoscopy across gastroenterology programs of all sizes
EvoEndo®, Inc. (EvoEndo) today announced that sedation-free transnasal endoscopy (TNE) is reaching a broader range of gastroenterology programs, including clinic settings without dedicated anesthesia coverage or operating room access.
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Ozlo launches Sleepbuds® 2, the world’s smallest earbuds designed for sleep
Ultra-small Sleepbuds engineered to help people fall asleep faster, stay asleep longer, and wake up more restored with all-night comfort, 14-hour battery life, noise-masking technology, and personalized sleep insights.
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Dopl is developing robotics for remote ultrasounds (and one day, much more)
Dopl Technologies is developing an ultrasound robotics platform for patient imaging by remote sonographers.
Dopl Technologies raises $6.3 million seed round to advance robotic ultrasound platform toward FDA clearance
Dopl Technologies has raised $6.3 million in seed financing to accelerate development and regulatory approval of its telerobotic ultrasound platform, positioning the company to expand access to diagnostic imaging through remotely operated robotic systems.
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Universal Brain Receives FDA 510(k) Clearance for Rapid Brain-Function Measurement Platform for Psychiatry
Universal Brain, a neurotechnology company pioneering objective brain-function measurement for mental health, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its proprietary UB ERP System, which measures brain function using electroencephalography (EEG) and event-related potentials (ERPs).
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John Martin, Executive Vice President and Chief Medical Officer at CardioSense, is shortening the time between diagnosis and care with breakout new technologies
UT Southwestern profiles alumnus John Martin, M.D., Executive Vice President and Chief Medical Officer at CardioSense.
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Magnendo secures $18M series A financing to transform endovascular access for stroke intervention
MIT spinout to accelerate product development and first-in-human studies of its magnetic robotic navigation platform designed to dramatically improve the speed and reliability of neuro-endovascular procedures
AcQumen Medical joins SPARK for Innovations in Pediatrics, a Biomedical Advanced Research and Development Authority (BARDA) Accelerator Network hub
AcQumen Medical has joined the SPARK for Innovations in Pediatrics portfolio, a BARDA Accelerator Network hub, as a recipient of non-dilutive funding.
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NeuraNova receives FDA 510(k) clearance for STEDI Device
NeuraNova, Inc., a medical technology company developing portable, noninvasive technologies for neurological care, today announced that the U.S. Food and Drug Administration has granted 510(k) clearance to the STEDI Device.
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TYBR Health announces $30 million series A financing to expand access to the B3 GEL® System
TYBR Health today announced a $30 million Series A financing led by Vensana Capital and Mutual Capital Partners, with participation from Neovate Capital Partners and existing investors.
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ReConstruct Bio was voted the Most Investable Company at Seed2Table’s inaugural Life Sciences & Tech Investor Evening
ReConstruct Bio was voted the Most Investable Company at Seed2Table’s inaugural Life Sciences & Tech Investor Evening in Boston.
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Amplitude-modulated kilohertz stimulation targeting beta-band activity disrupts motor learning featuring Magnetic Tides
A new bioRxiv preprint uses Magnetic Tides’ kilohertz transcranial magnetic perturbation (kTMP) to probe the role of cortical rhythms in human motor learning.
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Prof. Rachel Brem named Feminai’s Chief Medical Officer
Feminai has welcomed breast imaging expert Prof. Rachel Brem as its Chief Medical Officer.
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Use of single-use ultra-slim endoscopes for evaluation of pediatric esophageal varices: A pilot feasibility study featuring EvoEndo
A pilot feasibility study published in JPGN Reports evaluated EvoEndo’s single-use ultra-slim gastroscope in children with esophageal varices.
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After 17 Years at 3D Systems, Katie Weimer is betting on regenerative breast tissue featuring GenesisTissue
3DPrint.com profiles GenesisTissue founder Katie Weimer and the company’s 3D printed scaffold for regenerating breast tissue after cancer surgery.
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Psychiatry lacks biomarkers. Can this EEG ballcap get a base hit? Featuring Universal Brain
Universal Brain just announced an FDA 510(k) clearance for its Neurotique™ platform, which offers a five-minute assessment to measure cognitive and emotional brain function in support of psychiatric diagnosis and treatment.
52North has been granted its first US patent
52North has been granted its first US patent, strengthening the IP foundation behind its technology.
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ClearCam™ Wins AFWERX SBIR Phase I Award to Advance ClearScope IQ™
ClearCam™, Inc., an Austin-based medical device company focused on minimally invasive surgery, announced its selection by AFWERX for an SBIR Phase I contract worth $74,360.
First successful human cases using first console-free portable Cryocatheter system for bronchoscopic procedures featuring Endocision
Endocision is pleased to announce the successful completion of the first series of human clinical cases using its Cryocision flexible cryocatheter system at leading Quebec hospitals.
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Neuspera Integrated Sacral Neuromodulation System (iSNM) to Receive Same Medicare Payment as Legacy Implantable SNM Devices Under Proposed 2027 CMS Rule
Neuspera Medical today highlighted that the Centers for Medicare & Medicaid Services (CMS) has confirmed the assignment of the billing code for the Neuspera Sacral Neuromodulation System (SNM) to payment level APC 5464 in the proposed CY 2027 Outpatient Prospective Payment System Rule.1 The assignment provides the externally powered integrated SNM (iSNM) system the same Medicare payment as all other neuromodulation implantable therapies for urinary urge incontinence.
Feminai announces launch of new clinical pilot with Maccabi Healthcare Services
Women screened through Maccabi’s mobile mammography units across Israel will be able to use the Feminai breast assessment kit.
Winter Innovations Receives FDA 510(k) Clearance and PCCP Authorization for Expanded EasyWhip® Family
Winter Innovations, Inc. a medical device company developing innovative solutions for orthopedic soft tissue surgery, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the expanded EasyWhip® Family.
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Pain monitoring data to be available in hospital EHRs through Philips Capsule featuring Medasense Biometrics
The integration enables streaming of the patient’s NOL-Nociception Level Index® data to EHRs, supporting personalized analgesia in surgery and critical care.
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AtaCor Medical Announces First Patient Treated Globally in its ALARION-EV Pivotal Trial
AtaCor Medical, Inc., a privately-held medical device company focused on transforming cardiac rhythm management, announced today the enrollment of the first patient in the company’s ALARION-EV study (NCT07324031).
Maria Artunduaga, CEO of Samay, named an awardee of the Bayer Foundation Women Entrepreneurs Award 2026
Samay CEO Maria Artunduaga is one of 15 women selected for the Bayer Foundation Women Entrepreneurs Award 2026, from more than 1,100 applicants.
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EpiWatch named winner of the MedTech Ahead Startup Competition
EpiWatch was named the winner of the MedTech Ahead Startup Competition, hosted by Smith+Nephew.
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Lenoss Medical exhibit at the 21st Annual The State of Spine Think Tank and Investment Summit in San Jose del Cabo
Lenoss Medical exhibited OsteoPearl at the 21st Annual The State of Spine Think Tank and Investment Summit in San Jose del Cabo.
OncoRes Medical Awarded $3 Million CRC-P Grant to Advance Precision Prostate Cancer Surgery
OncoRes Medical has been awarded $3 million in funding under the Australian Government’s Cooperative Research Centres Projects (CRC-P) program to explore the application of the Company’s proprietary Quantitative Micro-Elastography (QME) imaging technology in prostate cancer surgery.
Peer-reviewed evidence on the Noah Labs Vox algorithm, published in the European Journal of Heart Failure
Using short voice recordings, the Noah Labs Vox algorithm predicted heart failure hospitalisations with 84% sensitivity and a median 29-day warning.
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Neal Piper of Luminoah Named EY US Entrepreneur Of The Year® 2026 Mid-Atlantic Award Winner
Neal Piper, Founder and CEO of Luminoah, has been named an EY US Entrepreneur Of The Year® 2026 Mid-Atlantic Award winner. Piper was selected from nearly 1,000 program participants, including 592 finalists across 17 regions, in recognition of his entrepreneurial leadership, innovation, and commitment to improving the lives of patients and caregivers.
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Wavelet Medical Receives ARPA-H Award to Support Validation of Novel Fetal Brain Monitoring Technology
Wavelet Medical announced today an award from the Advanced Research Projects Agency for Health (ARPA-H) to support validation of its novel fetal brain monitoring technology.
MiWEndo Initiates Final Stage of Pivotal Trial for Microwave-Based Colonoscopy System
Company advances clinical validation of its add-on technology designed to support lesion detection through real-time microwave sensing and acoustic alerts during colonoscopy.
Access Vascular and Medline Enter Multi-Year Agreement to Launch Cobranded Next-Generation Vascular Access Catheters
Access Vascular, Inc. (“AVI”), a medical device company specializing in developing advanced vascular access solutions, and Medline, the largest provider of medical-surgical products and supply chain solutions serving all points of care, today announced a multi-year agreement to accelerate the rollout of AVI’s next-generation catheters, HydroMID® and HydroPICC®, which recently received an anti-thrombogenic indication from the FDA.
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CroíValve Announces Expansion of Series B Financing with $27 Million Additional Capital to Fund DUO Adapt in an Enlarged TANDEM II Study
CroíValve, a pioneering medical device company focused on the development of a novel transcatheter device for the treatment of tricuspid regurgitation, announced today the closing of $20 million Series B expansion financing, along with $7 million European Innovation Council (EIC) and DTIF grant financing.
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From Blind Biopsies to Precision: Reinventing Medical Imaging with Reza Khorasaninejad, Founder & CEO at LEADOPTIK
Lung cancer biopsies are still being done blind more often than you’d think, leading to costly diagnostic errors.
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GelSana collaborators receive prestigious American Burn Association Research Award for CleraFlex research
Researchers evaluating GelSana’s CleraFlex™ technology received the American Burn Association’s 2026 Robert B. Lindberg Basic Scientist Paper Award.
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Multicenter study demonstrates specimen PET-CT provides actionable information at the point of decision-making, improving identification and management of positive margins during breast-conserving surgery featuring XEOS
XEOS, a medical technology company advancing intraoperative molecular imaging, today announced the publication of the BrIMA (Breast cancer Intraoperative Margin Assessment) study in JAMA Surgery, world’s leading peer reviewed surgical journals.
Inflammatix Collaborates with University of Nebraska Medical Center to Support Rapid Response to the Hantavirus Outbreak Using TriVerity®
Inflammatix, a leader in precision diagnostics for acute infection, today announced its collaboration with the University of Nebraska Medical Center and the National Quarantine Unit to support the response to the hantavirus outbreak using its TriVerity® test.
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Triangle medtechs earn spots in prestigious MTI Accelerator Cohort featuring OsteoCure Therapeutics and SonoVascular Inc.
SonoVascular Inc. and OsteoCure Therapeutics, both based in the Triangle, have been selected for the highly competitive MedTech Innovator (MTI) 2026 Accelerator Cohort, highlighting the depth and momentum of North Carolina’s rapidly growing medtech ecosystem.
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Leading Plastic Surgeons Spotlight “Active Tension Offloading” as Emerging Standard in Surgical Closure at ASAPS featuring BRIJ Medical
During The Aesthetic Meeting recently held in Boston, Drs. Steven Sigalove, Holly Wall, Jason Pozner, and Vinaya Rednam shared clinical perspectives on how actively managing incisional tension at the time of closure is helping improve healing trajectories, reduce wound complications, and enhance aesthetic outcomes across a range of procedures.
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Subtle Medical Receives FDA Clearance for SubtleHD™(CT), Expanding AI-Powered Image Enhancement into CT Imaging
Subtle Medical, a leader in AI-powered medical imaging software, today announced FDA clearance for SubtleHD™(CT), an AI-powered image enhancement solution designed to reduce noise and improve low contrast detectability across CT imaging.
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DermaSensor Announces Class IIb CE Mark and Collaboration with NHS, Marking the Beginning of Its Global Expansion
DermaSensor has received Class IIb CE Mark for its non-invasive skin cancer detection device and announced a feasibility study in collaboration with the NHS.
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New partnership brings Ligence Heart to University of Hong Kong students in HKUx course
Ligence has partnered with the University of Hong Kong to teach echocardiography analysis with Ligence Heart in the HKUx course “Advanced Cardiac Imaging: Echocardiography.”
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GT Medical Technologies Completes Oversubscribed $100 Million Series E Equity Financing to Advance Commercial Treatment for Patients with Operable Brain Tumors
Financing round led by new investor Viking Global Investors with participation from key existing investors
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Governor Moore Announces Nearly $7 Million in ‘Build Our Future’ Grant Awards to Support Innovation Infrastructure Development featuring CoapTech and Neurava
Governor Wes Moore today announced that the Maryland Department of Commerce has awarded 11 grants totaling nearly $7 million through the Build Our Future Grant Program. The recipients represent projects that will support innovation infrastructure development in eligible technology sectors.
Featuring Osteoboost Health: Can a vibrating belt help protect bones and muscle health?
NPR looks at how the FDA-approved Osteoboost wearable vibration belt is giving some women a tool that could slow bone density loss.
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Decoding Sepsis: Rethinking How We Detect Critical Illness with Inflammatix Co-Founder and CEO, Tim Sweeney, MD, PhD
On the Innovate & Elevate podcast, Inflammatix Co-Founder and CEO Dr. Tim Sweeney discusses how AI and host-response diagnostics could transform sepsis detection.
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Acorai wins award for Innovation in Cardiology at CSI Frankfurt 2026
Acorai has won the Jon DeHaan Foundation’s Award for Innovation in Cardiology at CSI Frankfurt 2026.
New technology changing the way cancer cells are identified featuring OncoRes Medical
OncoRes Medical was featured on 9 News Australia in a story on new technology that identifies breast cancer cells during surgery.
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FineHeart welcomes Pierre Chauvineau to board of directors
FineHeart has welcomed medtech veteran Pierre Chauvineau to its Board of Directors as it advances development of FlowMaker®.
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nView medical surpasses 1,000 surgeries
nView medical’s nView s1 intraoperative 3D imaging and navigation system has surpassed 1,000 surgeries.
AccurKardia Granted Patent for AI-Driven ECG Detection of Cardiac Amyloidosis
AccurKardia, Inc., an ECG analytics software company focused on establishing ECG as a broad biomarker, today announced that it has been granted US Patent No. 12,620,488 for the company’s proprietary machine-learning-based system for identifying cardiac amyloidosis from a standard, routinely performed 12-lead ECG.
Subtle Medical bags $33M to advance AI-powered imaging workflow solutions
Subtle Medical has secured $33 million in growth capital, led by Morgan Stanley Expansion Capital, to accelerate its AI-powered imaging solutions.
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PanTher Completes Dose Escalation Phase in Non-Metastatic Pancreatic Cancer Phase 1b Trial and Appoints Tim Clackson to the Board of Directors
Dose expansion phase now enrolling across the U.S., with data expected in first half of 2027
OncoRes Medical announces that it has been awarded a Category III CPT code by the American Medical Association
OncoRes Medical has been awarded a Category III CPT code by the American Medical Association for its ELORA® system, active from January 2027.
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EpiWatch, Inc. Announces Publication of Landmark Phase III Study in Neurology Open Access
EpiWatch today announced the publication of its Phase III clinical study in Neurology Open Access, demonstrating strong performance of its Apple Watch–based seizure detection application in identifying tonic-clonic seizures (TCS) across pediatric and adult populations ages 5 and up.Over 3.5 million Americans are impacted by epilepsy.
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Cardiosense Receives FDA De Novo Classification for Novel Cardiac Technology Designed to Improve Care for Patients with Heart Failure
Cardiosense, a healthcare technology company focused on heart failure care, today announced that the U.S. Food & Drug Administration (FDA) has granted De Novo classification for its PCWP Analysis Software™, a first-in-class technology to estimate a key indicator of heart health noninvasively.
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Flosonics Medical Earns FDA Clearance for FloPatch Update
Flosonics Medical has announced it received a new FDA 510(k) clearance (K252810) for its FloPatch (FP120), marking a significant milestone in the evolution of wearable hemodynamic monitoring.
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FDA Grants World’s First Neuromodulation Device to Treat Symptoms of PTSD featuring Neurovalens
Neurovalens’ Modius Spero has received FDA De Novo approval, becoming the world’s first neuromodulation device authorized to treat symptoms of PTSD.
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Zonova Closes £2.1m Seed to Scale Z-ROS® Antimicrobial Protection
Zonova has closed a £2.1 million seed round led by THENA Capital to scale its Z-ROS® antimicrobial technology for medical devices.
Arsenal Medical Receives FDA IDE Approval for the RADIANT Pivotal Trial of NeoCast™ in Chronic Subdural Hematoma
A randomized, controlled study of a novel liquid embolic, NeoCast, adjunctive to surgery
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Published Review Highlights Advantages of Needle-free Intradermal Delivery Over Traditional Needle and Syringe featuring PharmaJet
Novel needle-free Intradermal (ID) delivery technologies provide effective alternatives to traditional Mantoux ID administration using needles.
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Empirical Spine Announces First Commercial LimiFlex® Cases at Stanford Medicine, Marking U.S. Launch of Motion-Preserving Alternative to Fusion for Degenerative Spondylolisthesis
First U.S. commercial cases establish LimiFlex as an outpatient, motion-preserving stabilization option
Zenflow Presents the BREEZE™ Pivotal Clinical Trial at the American Urological Association Annual Meeting
Data Supported the FDA Approval of the Zenflow Spring® Implant and Delivery System for BPH
A standard workup pointed to discharge. Inflammatix’s TriVerity pointed to infection
In a recent case, Inflammatix’s TriVerity® flagged a very high bacterial score in a patient whose standard workup pointed to discharge.
LightHearted AI receives investment from Draper Associates
Draper Associates has announced it is backing LightHearted AI, which measures health insights using light and decodes them with AI.
Reducing Heart Failure Readmissions Through Objective Congestion Assessment featuring Acorai
Acorai’s new white paper explores how pressure-informed, non-invasive monitoring could support more objective heart failure care.
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Epineuron Receives FDA 510(k) Clearance for Evala® Nerve Stimulator
Evolution in intraoperative nerve identification and evaluation.
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Avoiding tracheostomy and achieving an excellent outcome with Lungpacer Medical’s AeroPace
One of the first commercial patients treated with Lungpacer Medical’s AeroPace at UI Health in Chicago avoided tracheostomy.
What You Can (and Can’t) Do to Improve Your Bone Health featuring Osteoboost Health
But we may be on the brink of a new era in preventative treatment. There is promising new research that looks at a “biological switch,” normally triggered by exercise, that helps keep bones strong—offering a potential path for drugs that might mimic physical activity.
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Aurie Receives FDA De Novo Grant for First Automated Safely Reusable Intermittent Urinary Catheter System
Aurie announced that the Aurie Reusable No-Touch Intermittent Catheter System™ has been granted marketing authorization from the U.S. Food and Drug Administration (FDA) through the Class II De Novo pathway—establishing it as the first ever reusable intermittent urinary catheter system and creating a new device classification in an industry that exclusively relied on single-use catheters for decades.
PharmaJet® Tropis® Needle-free Injection System Selected to Deliver 1.4 Million Polio Vaccine Doses in Nigeria
PharmaJet’s Tropis ID Needle-free Injection System will deliver approximately 1.4 million doses of fractional inactivated polio vaccine in Nigeria.
RIVANNA Receives FDA 510(k) Clearance for Accuro XV Musculoskeletal Ultrasound Imaging System
RIVANNA has received FDA 510(k) clearance for its Accuro® XV diagnostic ultrasound system for musculoskeletal imaging.
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Bright Uro Receives FDA Clearance For Glean® Abdominal Sensor
Bright Uro, a medical device company with a mission to transform care for lower urinary tract dysfunction (LUTD) through innovations in urodynamics, today announced that the U.S.
Nanochon manufactures first batch of Chondrograft implants
Nanochon has brought its manufacturing cell at The Launchport online and produced its first batch of Chondrograft implants ahead of its pivotal trial.
Ryan James of Dopl Technologies recognized as PSBJ 40 Under 40
Ryan James of Dopl Technologies has been named to the Puget Sound Business Journal’s 40 Under 40 Class of 2026.
Multi4 System receives CE Mark
Multi4 Medical has received CE Mark for the Multi4 System, an all-in-one flexible endoscopic instrument for treating bladder cancer in outpatient care.
Osteoboost Health CEO, Laura Yecies, named to Women of Wearables (wearables, health tech & femtech)’s list of 100 trailblazing leaders in (peri) menopause
Osteoboost Health CEO Laura Yecies has been named one of Women of Wearables’ 100 trailblazing leaders in (peri) menopause.
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Mobia Medical plans IPO
Mobia said its Vivistim System, which received premarket approval in 2021, is the only approved solution for chronic ischemic stroke survivors with moderate to severe upper extremity impairments.
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Joana Cartocci of Robeauté named finalist for the VivaTech Female Founder Award
Robeauté co-founder Joana Cartocci is a finalist for the VivaTech Female Founder Award and will take the stage at VivaTech in Paris.
RIVANNA’s Accuro XV demonstrates feasibility of musculoskeletal imaging by non-physician users with minimal training
A study in the Journal of Emergency Medicine found non-physicians could acquire diagnostic-quality extremity images with Accuro XV after one hour of training.
Cruxx podcast: Building the world’s smallest feeding pump with Neal Piper featuring Luminoah
On the Cruxx podcast, Luminoah founder and CEO Neal Piper shares how his son’s cancer diagnosis led him to reinvent tube feeding technology.
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Plexāā wins Red Dot Design Award as it reshapes pre-operative care and surgical outcomes with its novel BLOOM⁴³ app and medical device
Plexāā has been awarded the Red Dot Award 2026 for Product Design for its BLOOM⁴³ pre-operative care platform.
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Investors inject £17m into King’s College London medical spinout Hypervision Surgical
A university spinout which specialises in hyperspectral imaging to assist surgeons has clinched a £17m funding boost from investors including London-listed IP Group.
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Nutromics secures AU$3 million in CRC Projects funding to develop world-first sepsis management patch
Building on landmark Nature Biotechnology findings, Nutromics secures AU$3 million in a AU$11.2 million consortium to develop a world-first wearable sepsis patch.
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Craif appoints Takeo Mukai as CFO through local U.S. hire
Craif has appointed former Medtronic finance director and multi-exit executive Takeo Mukai as CFO to accelerate its U.S. expansion.
Bright Uro launches Glean® patient registry to create Urodynamic Intelligence™
Bright Uro has launched the Glean Registry to collect de-identified data from commercial use of its Glean® Urodynamics System.
Avenda Health’s Unfold AI Included in Expanded Medicare Physician Fee Schedule Across West Coast and Mountain West Regions
Avenda Health, an AI healthcare company creating the future of personalized prostate cancer care, today announces Unfold AI is now included in Medicare’s Physician Fee Schedules across the West Coast and Mountain West regions.
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Neurava Awarded $4 Million NIH Blueprint Optimizer Award to Develop SUDEP Risk Stratification Algorithm
Neurava Inc., an innovative medtech startup focused on advanced wearable monitoring solutions for epilepsy, today announced that it has been awarded a $4 million NIH Blueprint MedTech Optimizer award to support the development of a Sudden Unexpected Death in Epilepsy (SUDEP) risk stratification and forecasting algorithm.
Samay wins StartCo
Samay won StartCo after a room of more than 15,000 people voted it into the finals from 350 startups across Latin America.
Luminoah wins FDA clearance for enteral feeding pump system
Luminoah has received FDA clearance for Luminoah Flow, an enteral feeding system for those who rely on tube feeding.
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InVera Medical reports 12-month results from pilot trial of InVera infusion device showing vein closure in 90% of patients, statistically significant quality of life improvements, and excellent safety
12-month pilot results for the InVera Infusion Device, presented at the Charing Cross Symposium, show statistically significant symptom improvements and an excellent safety profile.
RIVANNA expands multi-site clinical study for Accuro XV musculoskeletal imaging system
RIVANNA has expanded its Accuro XV clinical studies from two to eight sites nationwide following a BARDA funding option.
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FDA 510(k) Clearance of the HYALEX Slalom™ MTP Hemiarthroplasty System
Regulatory milestone positions company for initial commercial entry into large and underserved foot & ankle market
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Conavi Medical Announces FDA 510(k) Clearance of its Next-Generation Hybrid IVUS-OCT System for Intravascular Imaging
First co-registered and co-aligned IVUS-OCT Platform for Intravascular Imaging
Osteoboost raises $8M to scale FDA-cleared wearable for bone health in postmenopausal women
More than 2,500 physicians have prescribed Osteoboost to date, the first FDA-cleared prescription wearable empowering women to proactively protect and preserve their bone density and bone strength
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Houston VA adopts Caretaker Medical’s VitalStream™ platform, advancing gold-standard wireless, continuous, non-invasive hemodynamic monitoring for veterans
The Houston VA has implemented Caretaker Medical’s VitalStream™ platform for wireless, continuous, non-invasive hemodynamic monitoring of veterans.
AccurKardia announces multi-year agreement with Specialized Medical to power its state-of-the-art cardiac monitoring operations
AccurKardia’s FDA-cleared ECG analytics engine, AccurECG™ 2.0, is actively processing live-streaming ECG data for Specialized Medical’s Monitoring System in over 20 clinics and hospitals across four states.
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Aegis Ventures and Wavelet Medical Aim to Redefine the Standard of Care in Fetal Medicine
A breakthrough in fetal brain monitoring developed at Yale is moving from laboratory discovery to global commercialization through a pivotal partnership with Aegis Ventures, including $7M in seed funding.
Ligence secures second FDA 510(k) clearance, adding fully automated left ventricular strain analysis
Ligence has received a second FDA 510(k) clearance for Ligence Heart, adding fully automated LV Global Longitudinal Strain analysis and private cloud deployment.
Acorai wins American College of Cardiology Future Hub Innovation Pitch Challenge for non-invasive monitoring technologies
Acorai has won the American College of Cardiology Future Hub Innovation Pitch Challenge for Non-invasive Monitoring Technologies.
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Sibel Health Receives FDA-Clearance for ANNE® Maternal, a Comprehensive and Fully Wireless Maternal-Fetal Monitoring Platform
Sibel Health today announced FDA 510(k) clearance of ANNE® Maternal, the world’s first fully wireless, comprehensive maternal-fetal monitoring platform.
GelSana announces the introduction of CleraFlex™, the world’s first stretchable wound dressing
GelSana has introduced CleraFlex™, the world’s first stretchable wound dressing.
FDA Clears InVera Infusion Device to Treat Chronic Venous Disease
InVera Medical announced FDA 510(k) clearance for the InVera infusion device for the minimally invasive treatment of diseased leg veins, including varicose veins. The device is now approved for use in the United States and European Union within its indications.
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Kelvin Health selected as one of the 20 startups in the 2026 WIPO IP Management Clinic Program
Kelvin Health is one of 20 startups selected for the 2026 WIPO IP Management Clinic Program.
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Orthomod announces FDA clearance of MOD-C™ cervical implant, debuting novel CAMP™ biomaterial
The clearance marks the introduction of the calcium-acrylic modified polymer (CAMP) composite, representing a significant advancement in structural orthopedic implants.
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Madorra Enrolls First Patient in Pivotal Trial for Treatment of Moderate to Severe Vulvovaginal Atrophy: The WAVES Study
Breakthrough Device-Designated Therapy System Takes Important Step Toward Market Authorization
CNN Exclusive: The futuristic foam that stops deadly internal bleeding
CNN spoke with the first person in the world to be treated with this futuristic material, called Res-Q-Foam, after he was seriously injured in a car crash last year and had just moments to live.
Prana Surgical announces the Prana System™ receives FDA clearance
The FDA has cleared the Prana System™, an image-guided electrosurgical platform that enables minimally invasive, tissue-sparing excision.
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Zeto announces FDA 510(k) clearance of Zeto New Wave™, advancing efficiency in outpatient EEG
Zeto has received FDA 510(k) clearance for Zeto New Wave™, its newest EEG system for outpatient clinics and homes.
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SutureTech’s RapidFix first use in patients
After almost a decade of development, SutureTech’s RapidFix has been used in its first patients.
Medasense and Jefferson Health to collaborate on study of pain monitoring technology in spine surgery
The collaboration aims to establish real-world clinical and economic evidence for NOL-guided anesthesia.
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Anumana Secures FDA Clearance for First-of-Its-Kind ECG-AI Algorithm for Early Detection of Pulmonary Hypertension
Anumana, a leader in cardiovascular AI, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its pulmonary hypertension (PH) algorithm, an AI-enabled software-as-a-medical-device (SaMD) that detects early signs of PH, a serious and progressive condition affecting the lungs and right side of the heart.
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Artiness’ ARTICOR planner receives FDA 510(k) clearance as a software to plan structural heart and vascular procedures
Artiness has received FDA 510(k) clearance for ARTICOR Planner, its software for planning structural heart and vascular procedures.
Acorai announces first patient enrolled in 1,000-patient HOSP-HF study
Acorai has enrolled the first patient in HOSP-HF, a 1,000-patient observational study of non-invasive congestion assessment in decompensated heart failure.
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Starlight Cardiovascular Announces First Baby in the World Treated with Lifeline Stent System at Cincinnati Children’s Hospital
Starlight Cardiovascular announced that the first baby in the world was treated with its Lifeline™ Ductus Arteriosus Stent System at Cincinnati Children’s Hospital in January. The device is currently being studied under a U.S. Food and Drug Administration Investigational Device Exemption clinical trial.
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Landmark ALL-RISE trial results presented as a LBCT at ACC 2026 and simultaneously published in the New England Journal of Medicine featuring CathWorks
CathWorks FFRangio demonstrated similar clinical outcomes to pressure wire-guided treatment in the ALL-RISE Trial.
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Beacon Angels has invested in Akeyna
Beacon Angels has invested in Akeyna.
Nutromics senior scientist, Marsilea Booth, was recently interviewed by Ian Woolf for Diffusion Science Radio
Dr Marsilea Booth talked about wearable medical sensors at Nutromics on Diffusion Science Radio.
Global Nerve Foundation welcomes Newrotex as industry partners in 2026
The Global Nerve Foundation has welcomed Newrotex as one of its new industry partners for 2026.
OncoRes Medical adds Fremantle Hospital as second MARGIN clinical trial site
Fremantle Hospital has joined OncoRes Medical’s MARGIN clinical trial as its second site.
Multi4 is part of Sweden’s high-level business delegation to Texas
Multi4 Medical joined Sweden’s high-level business delegation to Texas, alongside Crown Princess Victoria.
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Xenocor Appoints David McNally as Chief Executive Officer, Antony Watson to Chief Commercial Officer and David Van Ness to Chief Technology Officer
Xenocor announces David McNally as CEO and leadership appointments as the company commences commercialization of its recently FDA 510(k)-cleared Saberscope™ surgical visualization system for minimally invasive and laparoscopic surgery.
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Neurofenix’s technology has been acquired by Bioness Medical, Inc.
Neurofenix’s neuro-rehabilitation technology has been acquired by Bioness Medical, Inc.
AI-Enhanced ECG flags aortic stenosis years before symptoms featuring AccurKardia
Matthew Segar, MD, of The Texas Heart Institute, discusses new research evaluating whether AI‑enabled ECG analysis can detect aortic stenosis years before traditional symptom‑driven diagnosis.
Nanochon team receives 3 nominations for the Maryland Tech Council’s 2026 ICON Awards
Three members of the Nanochon team are finalists for the Maryland Tech Council’s 2026 ICON Awards.
Peptide hydrogel enhances adipocyte viability and reduces inflammatory response in fat grafting: A preclinical study featuring Regenyx Medical
Regenyx Medical’s peer-reviewed preclinical study of its peptide hydrogel in fat grafting has been published in Aesthetic Surgery Journal Open Forum.
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World-first trial to fix failing hearts featuring Tau Medical
Tau Medical was featured on 9 News Australia in a story on a world-first trial of an innovation to fix failing hearts.
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Toro Neurovascular Announces FDA 510(k) Clearance for Toro 88 Superbore Catheter
Toro Neurovascular today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Toro 88 Superbore Catheter, marking a transformative milestone for the company and the commercial introduction of its first proprietary neurovascular access catheter platform.
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Vitestro Raises $70 Million in Oversubscribed Series B Financing to Advance Autonomous Robotic Phlebotomy and Commercial Readiness
Vitestro, the pioneer in medical robotics advancing automated diagnostic blood collection, today announced the close of a $70 million oversubscribed Series B financing.
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May Health Raises $11.7M to Advance its Novel Technology to Treat PCOS-related Infertility
May Health, a medical device company dedicated to helping women living with polycystic ovary syndrome (PCOS), today announced that it raised €10 million ($11.7M) with participation from current investors, including Sofinnova Partners, Trill Impact, and Bpifrance, as well as new investor Nexpring Health™.
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Droplet IV announces leadership transition: Henriette Kirkegaard named CEO, Matthias Heschel joins as CTO
Droplet IV’s Chair, Henriette Kirkegaard, is assuming the role of CEO, and Matthias Heschel joins as CTO.
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Multiphze partners with Gosnell Medical Sales across the western United States
Gosnell Medical Sales is now representing Multiphze across 11 western U.S. states.
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Enspectra Health wins pitch competition at a Beauty, Tech & Longevity Summit
Enspectra Health won a pitch competition at a Beauty, Tech & Longevity Summit.
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DeviceTalks Weekly podcast: Armor Medical’s wearable could give earlier warnings of severe hemorrhaging before it’s too late
In this episode, Armor Medical Co-founder and CEO Kelsey Mayo shares her ultimate entrepreneurial journey. Mayo recognized early on that her career needed to make an impact, but the focus of her passion became clear after a frightening experience of her own.
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Avisi Technologies Announces $10.7M Capital Raise to Advance Novel Glaucoma Device Development
Avisi Technologies, Inc., an ophthalmic medical device company advancing novel, sight-saving technologies, announces the closing of $10.7M in new financing.
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Liquet™ Medical Receives Second FDA 510(k) Clearance for Versus™ Catheter
Liquet Medical Inc., a pioneering medical device company committed to advancing patient care through innovative technologies, today announced it has received a second 510(k) clearance from the U.S.
Rounds Podcast: Half of America has no cardiologist — software bridges that gap with AccurKardia CEO Juan C. Jimenez
Juan C. Jimenez addresses the heart care crisis in the United States where half of all counties have no specialist to read heart scans. There are more monitors than ever but less time to look at the data. Software must help doctors find sickness before it spreads.
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Xenocor Announces FDA Clearance of Saberscope®, the First Single-Use 5mm Articulating Laparoscope for Enhanced Surgical Visualization
Xenocor, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the new Xenocor Saberscope®, a single-use 5mm articulating laparoscope designed for high definition (HD) visualization during minimally invasive abdominal (belly) and thoracic (chest) surgical procedures.
Newrotex first patient cohort achieves 6-month primary outcomes with zero adverse events
The first patient cohort in Newrotex’s first-in-human SilkAxons trial has reached the 6-month primary outcome milestone with no adverse events.
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Strutless bioresorbable BTK scaffold demonstrates technical success and primary safety in first cases featuring StentIt
Preliminary three-month results from the first five human implantations of StentIt’s resorbable fibrillated scaffold (RFS) reveal a technical success rate of 100% and no device- or procedure-related serious adverse events at 30 days in patients with below-the-knee (BTK) chronic limb-threatening ischaemia (CLTI).
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FDA Grants PMA Approval to LimiFlex™ Dynamic Sagittal Tether featuring Empirical Spine
San Carlos, CA — February 18, 2026 /OrthoSpineNews/ — The U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) to the LimiFlex™ Dynamic Sagittal Tether, a motion-preserving system for the treatment of lumbar spinal stenosis associated with Grade I degenerative spondylolisthesis following decompression.
Acute results of the ASCEND EV study: A new modality of parasternal extravascular implantable cardioverter-defibrillator therapy including antitachycardia pacing featuring AtaCor Medical
BackgroundExtravascular implantable cardioverter-defibrillators (EV-ICDs) are being developed to overcome limitations of current implantable cardioverter-defibrillators (ICDs).
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VB Spine Announces Intent to Acquire Exclusive Rights to Augmedics’ Spine Platform
VB Spine LLC (“VB Spine”), the largest privately held spine company, today announced it has entered into a definitive agreement to acquire exclusive rights to the xvision Spine System® (xvision) from Augmedics, adding augmented reality (AR) navigation to VB Spine’s growing enhanced visualization portfolio.
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Retia Medical Receives FDA 510(k) Clearance for Argos Infinity™, Expanding Cardiovascular Intelligence Across High-Risk Surgical and Critical Care Environments
Retia Medical today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Argos Infinity™, the company’s cardiovascular intelligence software platform designed for high-risk surgical and critical care environments across health systems.
First patient treated in OncoRes Medical’s MARGIN clinical trial
The first patient has been treated in OncoRes Medical’s MARGIN clinical trial at Fiona Stanley Hospital.
OncoRes Medical announces the appointment of Renee Ryan as non-executive director to the company’s board
Renee Ryan, former CEO of Cala Health, joins the OncoRes Medical board as non-executive director.
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InVera Medical achieves European CE Mark approval for new vein infusion device
InVera Medical, an Irish medical technology company, has received European regulatory approval for a new minimally invasive device designed to help physicians deliver treatment more effectively to diseased leg veins, including varicose veins.
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Crux of Medtech: A New Vital Sign for Heart Failure with Filip Peters, CEO of Acorai
In this episode of the Crux of Cardio, host Jordan Bergen sits down with Filip Peters, Co-founder and CEO of Acorai, to unpack how his team is building a non-invasive device that reads the pressures inside the heart, using machine learning inspired by oil and gas diagnostics.
Australian breast cancer innovators close $27M private funding round featuring OncoRes Medical
OncoRes Medical today announced it has closed an AUD $27M private funding round (‘the Funding round’) to progress clinical development and regulatory milestones for its Quantitative Micro-Elastography (QME) Imaging System, Elora™.
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Entirety Biomedical Closes $1.2 Million Seed Financing to Advance Absorbable Magnesium Implants for Orthopedic Fixation
Entirety Biomedical, a Michigan-based medical device startup developing bioabsorbable implant systems with its proprietary Curasorb technology, today announced the closing of a $1.2 million Seed financing round to advance toward first-in-human clinical trials.
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MVM invests in Neurent Medical
Neurent Medical has closed an oversubscribed €62.5 million ($74 million) Series C financing led by MVM Partners.
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Neuspera Medical announces milestone case of traditional sacral neuromodulation (SNM) system removed and replaced with the company’s integrated SNM system for urinary urge incontinence
Neuspera® Medical, Inc., the leading developer of integrated technologies powering the future of neuromodulation, today announced a milestone patient revision from a traditional sacral neuromodulation (SNM) system to the recently FDA-approved Neuspera SNM System, an integrated sacral neuromodulation (iSNM) system for urinary urge incontinence (UUI).
Plexāā Ltd. Achieves ISO 13485:2016 Certification for Its Medical Device Quality Management System
Plexāā Ltd., a brand-new Prehab™ tech platform revolutionizing the underserved pre-op phase, announces it has achieved certification to ISO 13485:2016 — Medical devices: Quality management systems – Requirements for regulatory purposes.
Featuring Newrotex: Could this spider’s silk help repair nerves?
Scientists are using spider silk to help develop surgical devices for nerve regeneration.
Total Flow Medical completes enrollment of its 10-patient first human study
Total Flow Medical has completed enrollment of its 10-patient first human study of its femoral arterial cannula, with no device-related adverse events.
Leadoptik reports first-in-human use of lung biopsy tech
Leadoptik today announced the successful first-in-human clinical use of its FDA-cleared Last Inch Assessment (LIA) system, the company tells MassDevice.The first-in-human use took place at the University of Chicago Medical Center.
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Simple patch can make medications safer and more effective featuring Nutromics
Vancomycin is the antibiotic doctors reach for when almost nothing else will work. It’s used in hospitals for serious drug-resistant infections, or for when an infection is spreading through the patient’s bloodstream.
Medtronic advances its innovation strategy with intent to acquire CathWorks
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it will exercise its option to acquire CathWorks, a privately held medical device company, which aims to transform how coronary artery disease (CAD) is diagnosed and treated.
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Tim Sweeney, Co-Founder and CEO of Inflammatix, Joins Sepsis Alliance Board of Directors
Sepsis Alliance, the leading patient advocacy organization dedicated to saving lives and reducing suffering by improving sepsis awareness and care, is pleased to announce that Tim Sweeney, MD, PhD, has joined its Board of Directors.
She Leads Biotech podcast features Dr. Meghana Helder-Surgeon, practicing cardiac surgeon and Founder & CEO of Octin Health
In this episode of She Leads Biotech, I sit down with Dr. Meghana Helder-Surgeon, practicing cardiac surgeon and Founder & CEO of Octin Health. She shares how one sleepless night in the OR — and one patient outcome she couldn’t let go of — led her to build a medtech company from her basement, starting with a garden hose, a drill, and a whole lot of determination.
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Prenosis Announces $20M BARDA Contract and $20M Series A Financing Round, Advancing Mission to Deliver Integrated Diagnostics and Therapeutics
Prenosis, a biology-based technology company delivering integrated diagnostics and therapeutics, announced today two major milestones: completion of its Series A Financing Round, and a contract from the Biomedical Advanced Research and Development Authority (BARDA), a component of the Administration for Strategic Preparedness and Response (ASPR) within the U.S.
FDA Clearance of LIA™ featuring LEADOPTIK
LIA™ (Last Inch Assessment) has officially received clearance from the U.S. Food and Drug Administration. On paper, this is a regulatory milestone. In practice, it represents a fundamental shift in how lung cancer can be approached at its most fragile and consequential moment.
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$41M Contract Fuels ATDev’s Vision for AI-Powered PT Ecosystem
New medical devices are hitting the market almost daily, improving the lives of patients living with a myriad of conditions.
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Strados Labs Announces Study Evaluating Remote Lung Sound Monitoring to Predict COPD Exacerbations
PHILADELPHIA, PA / ACCESS Newswire / January 28, 2026 / Strados Labs, a medical technology company advancing respiratory care through wearable technologies, today announced an observational research study evaluating remote lung sound monitoring in patients with chronic obstructive pulmonary disease (COPD) using its FDA 510(k) cleared RESP® Biosensor.
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Evaluation of a machine learning system for genomic antimicrobial susceptibility determination on a clinically representative test set featuring Day Zero Diagnostics
Next-generation sequencing is anticipated to transform infectious disease treatment by enabling faster diagnosis, yet a clinical-grade method for genomic AST determination is still lacking.
Acorai white paper: The emerging role of non-invasive cardiac and pulmonary pressure sensing in inpatient cardiology and the hospitalized heart failure workflow
Acorai has released Chapter 1 of its latest white paper on non-invasive pressure sensing in inpatient cardiology.
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Newrotex takes new R&D lab space at the Wood Centre for Innovation
Newrotex, a clinical-stage biotech start-up developing innovative silk-based medical devices for nerve repair, has taken 1680 sq ft (156 sq m) of manufacturing and R&D laboratory and office space at our Wood Centre for Innovation in Headington, Oxford, as it enters a critical phase of clinical and operational scale-up.
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HAPPE Spine Featured In Orthoworld’s Orthopedic Startups to Watch in 2026
HAPPE Spine has developed a fully synthetic biomaterial platform for bone integrating implants that look and act more like a biologic. The implants feature a bone-like structure and cell-friendly surfaces.
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FibriCheck expands its footprint in the Netherlands with four new hospital partnerships
FibriCheck is proud to announce partnerships with four leading Dutch hospitals: Amphia Hospital, Spaarne Gasthuis, Alrijne Hospital, and Rode Kruis Ziekenhuis. These partnerships strengthen our mission to make remote cardiac care more efficient, patient-centered, and cost-effective.
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mOm Incubators Receives FDA Clearance for First-of-Its-Kind Portable Incubator for Premature Babies
Potential for novel incubator to address key aspects of preterm neonatal care and reduce dependence on NICU
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Juniper Biomedical Wins Phase 3 NIH SPARC Neuromod Prize And Adds Frank Fischer to Board
Juniper Biomedical has won Phase 3 of the NIH SPARC Neuromod Prize, earning a $1.6 million cash award that the company said will support ongoing product development and clinical trials for its lead therapy targeting mixed urinary incontinence (MUI).
ATS Breathe Easy Podcast: Breathing in Innovation at RIS featuring Maria Artunduaga, MD, MPH, founder of Samay
The Respiratory Innovation Summit (RIS) is an event that unites the innovators, investors, clinicians and advocacy groups who are leading the charge to create powerful new treatments for diseases of the lungs and airways.
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Startup with Central Virginia ties moves cartilage-regrowing knee implant into human trials featuring Nanochon
For millions of people with knee damage, treatment options can be limited — especially before a full knee replacement is even considered. Now, a startup with ties to Central Virginia is reaching a major milestone that could change how certain knee injuries are treated.
LEADOPTIK Announces FDA Clearance of the LIA™ for Lung Biopsy Procedures
LEADOPTIK, Inc. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Last Inch Assessment™ (LIA) system, the world’s first system to use silicon photonics imaging technology and software designed to improve the accuracy of lung biopsy procedures.
In Conversation with Daniel Firth, Data & AI Manager at OncoRes Medical
Daniel Firth leads data and AI programs at OncoRes, overseeing a team of software developers, engineers, and data scientists.
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PREVENT: Preeclampsia Detection – Verifying a Novel Rapid Test featuring MOMM Diagnostics
Mathias Wipf of MOMM Diagnostics GmbH will improve their préXclude test to better enable its use in low- and middle-income countries (LMICs) as an affordable point-of-care diagnostic platform for prediction and detection of preeclampsia early in pregnancy.
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mOm Incubators Receives FDA Clearance for First-of-Its-Kind Portable Incubator for Premature Babies
Potential for novel incubator to address key aspects of preterm neonatal care and reduce dependence on NICU
Abbott and AtaCor Medical Collaborate on Advanced Extravascular ICD Technology
Abbott today announced a collaboration with AtaCor Medical to advance a next-generation investigational extravascular implantable cardioverter defibrillator (EV-ICD) system designed to deliver defibrillation therapy to people with life-threatening heart rhythms.
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Press Release Nanochon closes $4.1M Seed Prime II Funding Round
Nanochon, a Washington, DC-based orthopedic device company developing an implant for treating articular cartilage defects in the knee, has secured commitments to close an oversubscribed funding round, bringing its total capital raised to date to $11.3 million.
GelSana Hires Chief Commercial Officer
GelSana Therapeutics, Inc. (“GelSana”), a wound care company developing novel polymer-based dressings to accelerate healing, today announced that Donald Gregg has joined the company as Chief Commercial Officer (CCO).
PharmaJet’s Needle-free Injection System Selected to Administer DNA Immunotherapy for Advanced Melanoma in Late-stage Clinical Development following Positive Phase 2 Data
PharmaJet®, a company focused on improving the performance and outcomes of injectables through needle-free injection technology, announced that its partner Scancell has reported updated Phase 2 clinical data from the SCOPE study in unresectable advanced melanoma.
AccurKardia Secures FDA 510(k) Clearance of and Launches AccurECG 2.0
AccurKardia, an ECG-led diagnostics software company focused on transforming ECG data into a more powerful diagnostic tool and broad biomarker to improve patient outcomes and save lives, today announced U.S.
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FineHeart secures €83 million to support its growth
FineHeart, a clinical-stage medical technology company specializing in the development of innovative solutions for cardiology, announced today the completion of a €35 million first closing of its Series C financing round.
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Prevencio and Quadrant Health Announce Partnership to Integrate HART CVE and HART CADhs AI-Blood Tests into Primary Care
Prevencio, Inc., a leader in advanced, AI-driven multiprotein-based cardiovascular and cardiometabolic risk assessment, and Quadrant Health today announced a partnership agreement to integrate Prevencio’s HART® CVE and HART® CADhs blood tests into Quadrant Health’s primary care model.
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BRIJ Medical Oversubscribes Recent Fundraising Round Ahead of Expansion and Next-Gen Product Launch
BRIJ Medical, the company redefining surgical closure and post-surgical healing with active tension offloading, today announced that it has successfully oversubscribed its SAFE fundraising round, surpassing its initial target amid strong investor demand.
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TYBR Health’s B3 GEL System Makes its Clinical Debut in U.S.
Dr. Hanna Tammam, a fellowship-trained hand, elbow, and shoulder surgeon in Lubbock, Texas, is the first U.S. physician to use TYBR Health’s B3 GEL System in a procedure, the company announced.
How Inflammatix’s TriVerity supports faster infection diagnosis
USA Health recently became the first and only hospital in the state of Alabama to implement a breakthrough blood test to quickly identify and treat sepsis.
Nanochon’s first-in-human clinical trial has been officially listed on ClinicalTrials.gov (NCT07249489)
Nanochon’s first-in-human early feasibility study of its Chondrograft™ implant is now registered on ClinicalTrials.gov.
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FDA Clears BrainSpace Intellidrop, an automated neuro device that addresses ICU nursing shortages and builds training data for Physical AI
BrainSpace, a medical technology company building automated solutions for neuro injury, illness and degeneration, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Intellidrop, an automated brain fluid management system integrating proprietary hardware and software to achieve continuous brain pressure measurement and closed-loop, gravity-driven, precision drainage of brain fluid to a personalized volume or pressure goal.
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FDA Clears BrainSpace Intellidrop, an automated neuro device that addresses ICU nursing shortages and builds training data for Physical AI
BrainSpace, a medical technology company building automated solutions for neuro injury, illness and degeneration, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Intellidrop, an automated brain fluid management system integrating proprietary hardware and software to achieve continuous brain pressure measurement and closed-loop, gravity-driven, precision drainage of brain fluid to a personalized volume or pressure goal.
NASA Spinoff: Boosting Bone Health featuring Osteoboost Health
Recovering from a broken bone can be a long, painful experience — even life-threatening for the elderly.
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Nitinotes Announces First Patient Treated in Pivotal EASE™ Clinical Trial Evaluating the EndoZip™ Automated Suturing System for ESG
Nitinotes Ltd., an early commercial stage medical technology company developing fully automated endoluminal suturing solutions for obesity treatment, today announced that the first patient has been treated in its U.S.
Kelvin Health has signed a non-dilutive grant funding agreement for state support amounting to $2.9M
Kelvin Health has signed a $2.9M non-dilutive state grant funding agreement to boost its R&D, regulatory and early market access activities.
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Moon Surgical adds 5G and Wi-Fi to Maestro robots for cloud-based AI
Targeting a soft-tissue market led by Intuitive Surgical, Moon has invested in digital capabilities to try to differentiate its robots from the competition.
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CranioSense Awarded $5.5 Million in Federal Grants to Validate Noninvasive Neurotech
CranioSense, Inc., a neurotechnology company developing the world’s first noninvasive intracranial pressure (ICP) diagnostic and monitoring system, today announced the award of approximately $5.5 million in total non-dilutive funding through the NIH Blueprint MedTech Program and the U.S.
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NeuroBionics Announces Oversubscribed $10M Seed Round with Second Close Led by Future Ventures
NeuroBionics today announced the completion of its oversubscribed seed round, marking significant momentum as the company advances its endovascular neuromodulation platform toward first-in-human studies.
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RIVANNA announces FDA clearance of Accuro 3S Needle Guide Kit
RIVANNA®, developer of world-first imaging-based medical technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Accuro® 3S Needle Guide Kit consumables.
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Teal Health Partners with Thatch Marketplace to Increase Employee Access to At-Home Cervical Cancer Screening
Teal Health, a virtual women’s health platform and the creators of the first and only FDA-authorized self-collection device for at-home cervical cancer screening, today announced the availability of their services on the Thatch Marketplace.
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FDA Approves the Zenflow Spring® Implant and Delivery System for First-Line Interventional Therapy of Patients with Benign Prostatic Hyperplasia (BPH)
Zenflow, Inc. announced today the U.S. Food and Drug Administration (FDA) approval of the Zenflow Spring® Implant and Delivery System for the treatment of symptoms associated with benign prostatic hyperplasia (BPH), also known as enlarged prostate.
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Neurovalens granted FDA medical approval for weight management device
Neurovalens, a global leader in non-invasive neuro-technology, has been granted medical device De Novo approval from the US Food & Drug Administration (FDA) for Modius Lean, its prescribed treatment for weight management.
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CathVision Announces Appointment of Eric Thepaut as Independent Chairman of the Board and Releases ECGenius® System Version 3.5
CathVision, a medical technology company dedicated to improving clinical outcomes in cardiac electrophysiology through high-fidelity signal acquisition and intelligent software, today announced two major milestones: the appointment of Eric Thepaut as independent Chairman of the Board, and the commercial release of Version 3.5 of the ECGenius® System.
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How Biomedical Innovation Is Healing Animals to Help People featuring Purgo Scientific
Dustin Williams, CSO of Purgo Scientific, started on the road to the Vetlen Pouch through profound frustration with the state of infection care. As a researcher trying to find better ways to treat bone infections, he’d spent years working to improve antimicrobial coatings.
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Launch Tennessee announces FY26 SBIR/STTR Matching Fund companies, surpasses $1 billion in economic impact featuring Winter Innovations,
Launch Tennessee today announced the 32 companies selected for its FY26 SBIR/STTR Matching Fund, marking a historic milestone as the program surpasses $1 billion in total economic impact – measured through follow-on capital raised, additional grants leveraged, and wages generated across the State of Tennessee.
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Mirai Medical has been awarded €7.2M under the Disruptive Technologies Innovation Fund (DTIF) Call 7 for PIONEER – Pathology and Immuno-Oncology with Next-Generation Screening and Electroporation for Enhanced Response
Minister for Enterprise, Tourism and Employment Peter Burke TD, and Minister for Further and Higher Education, Research, Innovation and Science, James Lawless TD today announced funding of almost €39 million for seven additional projects under Call 7 of the Disruptive Technologies Innovation Fund (DTIF).
GT Medical Technologies Welcomes New GammaTile® Center of Excellence Program Designation
GT Medical Technologies, a medical device company dedicated to improving the lives of patients with brain tumors, today announced ECU Health as the latest GammaTile® Center of Excellence Program designation.
SutureTech Strengthens Board with Appointment of Industry Leader Ken Gall
SutureTech, a surgeon-founded medical device company pioneering advanced soft tissue repair solutions, announced the appointment of Ken Gall to its Board of Directors.
CMS Finalizes OPPS Payment for Eko Health’s SENSORA® Platform, Expanding Reimbursement for AI-Enabled Cardiac Disease Detection in Hospital-Associated Outpatient Care
Eko Health, a leader in AI-powered cardiac and pulmonary care, announced that the Centers for Medicare & Medicaid Services (CMS) has finalized national payment for its SENSORA® platform under the Outpatient Prospective Payment System (OPPS).
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VisCardia Secures $40 Million Growth Financing to Advance VisONE™ Heart Failure Therapy Toward PMA Approval
VisCardia, Inc., a medical device company pioneering a novel cardiac-support therapy for patients with heart failure, today announced it has secured $40 million in growth financing to advance the company’s path toward Premarket Approval (PMA) for its VisONE™ Synchronized Diaphragmatic Stimulation (SDS) Therapy.
Ligence Heart receives FDA 510(k) clearance
Ligence announces that its AI-powered echocardiography software, Ligence Heart, has received U.S. Food and Drug Administration (FDA) 510(k) clearance. Ligence Heart, is an AI-powered software that automates measurements and analysis of 2D transthoracic echocardiography (TTE) images and produces a structured report with several key cardiac structural and functional parameters.
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Little Sparrows Technologies Awarded Vizient Contract for Infant Care Equipment and Phototherapy
Little Sparrows Technologies, a leading innovator in neonatal care solutions, announced that it has been awarded a supplier contract with Vizient, Inc.
In a multicenter study, cross-modal imaging aligned with biopsy-confirmed histopathology and showed high physician reader agreement, supporting its FDA-cleared role in clinical assessment featuring Enspectra Health
In this diagnostic study, 65 participants undergoing skin biopsy were imaged with a novel cross-modal system. Expert readers used traditional hematoxylin and eosin histopathology to validate skin features identified on cross-modal imaging and to train blinded physician readers; in performance testing, blinded readers scored 96.4% accuracy in feature identification.
WA Startup Stories: From Theatre to Tech, Dr Kath Giles’s Rise as a Med‑Tech Trailblazer featuring OncoRes Medical
Dr Kath Giles has carved a remarkable path from the surgical theatre to the cutting-edge of medical innovation.
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Tufts tests tactile mattress to help preemies restart breathing featuring Prapela
BOSTON —A Boston hospital is working to help premature infants sleep more like babies. Doctors say it’s not as easy as it sounds.
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Distalmotion raises $150M to commercialize surgical robot
Distalmotion has designed Dexter to integrate into existing surgical environments without the need for dedicated infrastructure. The robotic platform’s open architecture allows surgeons to use their preferred visualization systems and laparoscopic electrosurgical generators.
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Reinventing Dental Implants: A Drill-Free Future with iDentical & Global Health Impact Network
Join Iris Wedeking, CEO and Founder of iDentical, and Dr. Gary Goldman, Founder of Global Health Impact Network and Funds, for a candid fireside chat on how drill-free, patient-specific 3D-printed implants are poised to transform implant dentistry.
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Neocis Unveils Next-Generation AI-Powered Robotic System for Dental Implants
Neocis®, the pioneer behind the first and only U.S. FDA-cleared robotic system for dental implant surgery, today announced the launch and FDA approval of its next-generation robotic platform: Yomi S.
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CathWorks CFO, Mike Feher, and President & CEO, Ramin Mousavi, honored as part of the Orange County Business Journal OC500 2025 – named among influencers that include area executives, educators, and other community leaders
This marks the tenth edition of the Business Journal’s OC500, our annual inventory Directory of Influence.
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Hypervision Surgical Wins the Lippmann Award at IEEE WHISPERS Conference
Hypervision Surgical is proud to announce that we have been awarded the 2025 Lippmann Award, a global distinction recognising impactful innovation in hyperspectral imaging.
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Ozlo and Calm Partner to Launch Co-Branded Sleepbuds For More Restorative Sleep
Ozlo, the sleep technology company behind Ozlo Sleepbuds® and a pioneer in noise-masking innovation and sleep tracking insights, today announced its partnership with Calm, the mental health company with the #1 app for sleep, meditation, and relaxation.
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HAPPE Spine Reaches 1,000 Patients with the INTEGRATE®-C Interbody Fusion System
HAPPE Spine, an early stage company advancing clinical outcomes with a proprietary biomaterial and manufacturing platform for creating bone-integrating implants, announces that the INTEGRATE®-C Interbody Fusion System has been implanted in more than 1,000 patients, demonstrating clinical adoption of the HAPPE® platform across more than 30 surgeon users and 40 facilities nationwide.
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Augmedics wins FDA clearance for next-gen AR headset for use with Xvision Spine System
Augmedics announced today that it received FDA 510(k) clearance for X2, its next-generation augmented reality (AR) headset.
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California Association of Health Facilities (CAHF) Selects Darmiyan as Preferred Provider for Cognitive Health Solutions
The California Association of Health Facilities (CAHF) has selected Darmiyan, Inc., a leading neurotechnology company, as its only Preferred Provider for Cognitive Health Solutions.
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Nitinotes Receives CE Mark Approval of EndoZip™, the First Fully Automated Suturing System for Endoscopic Sleeve Gastroplasty
Nitinotes Ltd., a medical device company transforming the treatment of obesity, today announced it has received CE Mark approval for the EndoZip™ System, the first fully automated suturing platform for endoscopic sleeve gastroplasty (ESG).
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ATDev Joins $41 Million ARPA-H Initiative to Build the Future of Robotic Mobility and Independence
Assistive Technology Development, Inc. (ATDev) announced today that it is a subcontractor for the Robotic Assistive Mobility and Manipulation Platform (RAMMP) program, awarded to the University of Pittsburgh under the Advanced Research Projects Agency for Health (ARPA-H) for up to $41 million.
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FDA Greenlights Pivotal Study of PRECISIS’ Minimally Invasive Brain-Stimulation Therapy for Drug-Resistant Epilepsy
Heidelberg, Germany – November 6, 2025. PRECISIS GmbH today announced that the U.S. Food & Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for its pivotal EASEE4US clinical study, marking a significant step toward U.S.
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Aqua Medical wins FDA IDE to launch trial for ablation procedure that treats diabetes
Aqua Medical has received an investigational device exemption (IDE) from the FDA for its ablation device intended to treat diabetes, the company told MassDevice ahead of an official announcement later today.
Multiphze Receives Innovative Technology Contract from Vizient
Multiphze, LLC is announcing that the MultiphzeÒ Enclosed Bladder Irrigation System has received an Innovative Technology contract from Vizient® the nation’s largest provider-driven healthcare performance improvement company.
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24-Month Clinical results for Healionics’ STARgraft featured at CiDA conference
Healionics Corporation, a developer of synthetic biomaterial-based medical devices, today announced the presentation of 24-month clinical results for its STARgraft arteriovenous (AV) graft at last week’s Controversies in Dialysis Access (CiDA) Symposium, the leading educational forum for surgeons, radiologists, nephrologists and medical staff who care for dialysis patients.
Conavi Medical Expands Leadership Team
Conavi Medical, a company focused on imaging tech to guide minimally invasive cardiovascular procedures, has revealed strategic leadership changes related to its planned commercial launch and expansion in the U.S.
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Avisi Technologies Announces Positive Twelve-Month Clinical Data of VisiPlate® Aqueous Shunt at AAO 2025
Avisi Technologies, Inc., an ophthalmic medical device company advancing novel, sight-saving technologies, presented positive twelve-month clinical data on VisiPlate® Aqueous Shunt from the VITA Trial during the 2025 American Academy of Ophthalmology (AAO) annual meeting.
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Fred Moll leads $3.4M seed round for Surgical Automations
Surgical Automations announced today that it closed a $3.4 million oversubscribed seed funding round to support its surgical robotics platform.
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Conavi Medical announces agreement with the Province of Ontario as part of the Life Sciences Scale-Up Fund
Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi” or the “Company”), a commercial-stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide minimally invasive cardiovascular procedures, is pleased to announce that it has entered into an agreement with the Province of Ontario as part of the Life Sciences Scale-Up Fund (LSSUF).
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PMcardio Reports Positive RCT Results and Late-Breaking Clinical Science for STEMI Detection
Presented as Late-Breaking Science at TCT 2025 by Dr. Timothy D. Henry, simultaneously published in JACC: Cardiovascular Interventions
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LATTICE MEDICAL raises €43 million to transform post-cancer reconstruction
LATTICE MEDICAL, a French Medtech company specializing in tissue engineering, announces a Series B fundraising round of €43 million, one of the largest of the year in the French Medtech sector.
PharmaJet® Tropis® Needle-free Injection System selected for Polio Immunization Campaign in Pakistan
PharmaJet®, a company that strives to improve the performance and outcomes of injectables with its innovative needle-free injection technology, today announced that their WHO prequalified Tropis ID Needle-free Injection System will be used in the latest polio immunization campaign in Pakistan, planned for late 2025.
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Hemorrhage can be a serious problem after pregnancy. Here’s how one medtech founder is tackling it featuring Armor Medical
A near-death experience with hemorrhage left a scientist searching for ways to detect serious blood loss early.
NEUROMARK® Now with Expanded Access on UnitedHealthcare’s Medicare Advantage Policy for Posterior Nasal Nerve Ablation
Neurent Medical, a leader in non-surgical treatments for chronic rhinitis, today announced that UnitedHealthcare’s Medicare Advantage policy has removed CPT 31242 posterior nasal nerve ablation using radiofrequency from its Experimental & Investigational (E&I) list, effective immediately giving over 10 million patients access to NEUROMARK.
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Onkos Surgical® Receives FDA 510(k) Clearance for ELEOS™ Proximal Tibia with NanoCept® Antibacterial Technology
Onkos Surgical, a leading provider of innovative solutions for complex orthopaedic procedures, announced that it has recently received a 510(k) clearance from the U.S.
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RIVANNA awarded $3 million CDMRP grant to develop military-optimized ultrasound guidance system for spinal interventions
RIVANNA®, developers of world-first imaging-based medical technologies, has been awarded with a Peer-Reviewed Medical Research Program (PRMRP) Technology/Therapeutic Development Award (TTDA) from the Congressionally Directed Medical Research Program (CDMRP).
Subtle Medical Announces Positive Findings from Proof-of-Concept Study with Bayer Investigating AI To Lower Gadolinium Dose in CE-MRI
Subtle Medical, Inc., a leader in AI-powered medical imaging solutions, today announced positive findings from a proof-of-concept (POC) study with Bayer, a leader in Radiology, evaluating Subtle Medical’s investigational SubtleGAD™ technology.
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Medtronic and DASI Simulations Partner to Advance the Future of TAVR Through Predictive Modeling and Personalized Planning
Medtronic plc, a global leader in healthcare technology, and DASI Simulations, a leader in AI-driven predictive modeling and digital-twin technology, today announced a strategic partnership to enhance access to DASI technology to optimize outcomes for patients undergoing transcatheter aortic valve replacement (TAVR) in the United States.
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Knowtex Selected by U.S. Department of Veterans Affairs to Deploy Ambient Clinical AI
Knowtex, a leading provider of ambient clinical intelligence, announces that it has been awarded a $15 million contract with the U.S. Department of Veterans Affairs (VA), and was a top 3 Winner of the 2024 AI Tech Sprint for Ambient Scribe.
New Study Shows Self-Guided Online Exercise Program Significantly Improves Strength and Reduces Fall Risk in Midlife and Older Women featuring Osteoboost Health
A new study to be presented at The Menopause Society (TMS) 2025 Annual Meeting by Osteoboost Health shows that a self-guided, online exercise program led to rapid and clinically meaningful improvements in leg strength and endurance — key factors in reducing fall risk — in women ages 40 to 89.
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Neuromod Prize announces two Phase 3 winners at HLTH 2025 featuring Juniper Biomedical
The Neuromod Prize, a $9.8 million competition to accelerate the development of targeted neuromodulation therapies, has announced two Phase 3 winners. The competition aimed to advance neuromodulation solutions and brought them much closer to having tangible patient impact, offering new hope to the millions of patients battling chronic or acute diseases.
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Adaptyx raises $14M to support multi-analyte monitoring biowearable
Adaptyx Biosciences announced today that it raised $14 million in seed funding to support its multi-analyte molecular monitoring device.
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Meet The Young Tech Trailblazers Building a New Future for Language, Learning and Medicine featuring StrokeDx
New technology is also driving innovation across medicine. Medical device company StrokeDx, founded by 2025 Science listers Alexander Ballatori and Shane Shahrestani, can diagnose stroke type in minutes instead of hours with its STEDI device.
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Redox and Kno2 Form Strategic Alliance to Transform Healthcare Data Exchange Nationwide
Redox, healthcare’s leading interoperability company powering flexible data exchange in real-time, and Kno2, the company leading the future of healthcare communication and a federally designated Qualified Health Information Network (QHIN), today announced a strategic alliance that solves healthcare’s dual challenge of moving clinical data at scale between the major healthcare networks and systems as well as making it instantly usable.
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Vivistim Co-Founder Named Innovator of the Year by the Congress of Neurological Surgeons featuring MicroTransponder
MicroTransponder®, Inc., a commercial-stage medical technology company and developer of the breakthrough Vivistim® Paired VNS™ System for chronic stroke recovery, today announced that its co-founder and chief scientific officer, Navzer Engineer, MD, Ph.D., won the Congress of Neurological Surgeons (CNS) Innovator of the Year Award.
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ATDev Secures $3 Million Seed Investment to Scale Assistive Mobility Ecosystem
Assistive Technology Development, Inc. (ATDev), a pioneer in AI-enabled, high-performance rehabilitation and personal mobility solutions, announced today that it has raised $3 million in Seed funding.
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Cleveland Clinic Collaborates with DASI Simulations to Create AI-Powered Technology for Structural Heart Care
Cleveland Clinic has entered into an agreement with DASI Simulations to co-develop the next generation of AI predictive modeling solutions for the treatment of structural heart diseases.
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LATTICE Medical and Robeauté win the Gold and Runner-up respectively in the “Technology Innovation” category of “Les Trophées Santé Future 2025”
The winners of the second edition of the Future Health Trophies were announced on Thursday, October 16, 2025. The awards celebrated the most remarkable start-up innovations and the most successful collaborations in the health sector.
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Effective Management of Venous Leg Ulcers by Copper Dressings – Case Series featuring MedCu Technologies
*Corresponding Author: Gadi Borkow, MedCu Technologies Ltd., 4672200 Herzliya, Israel.
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OtoNexus Medical Technologies Ranks #4 Among Micro Companies on Puget Sound Business Journal’s 2025 Washington’s Best Workplaces
OtoNexus Medical Technologies has been named to Puget Sound Business Journal’s Washington’s Best Workplaces for 2025, ranking #4 in the Micro Companiescategory.
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Koya Medical Honored by Goldman Sachs for Entrepreneurship
Today, Goldman Sachs (NYSE:GS) is recognizing Koya Medical (“Koya”) CEO Andy Doraiswamy, PhD as one of the Most Exceptional Entrepreneurs of 2025 at its Builders and Innovators Summit in Healdsburg, California.
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Avisi Technologies Receives FDA Approval to Study Novel Approach to Glaucoma Treatment
Avisi Technologies, Inc., an ophthalmic medical device company advancing novel, sight-saving technologies, announces that the US Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) submission for Avisi’s glaucoma treatment device VisiPlate®.
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Toro Neurovascular and Kaneka announce exclusive US distribution partnership
Toro Neurovascular has announced an exclusive distribution partnership with Kaneka Medical America for Toro’s novel neurovascular catheter portfolio in the US market, pending regulatory clearance.
Nutromics unveils world-first real-time multiplexed antibiotic monitoring breakthrough
Nutromics has announced a major milestone in wearable diagnostics, unveiling the world’s first real-time, continuous in vivo data for two antibiotics—vancomycin and tobramycin—measured simultaneously on a single device.
TIME has named Osteoboost one of its Best Inventions of 2025
Osteoporosis weakens bones as we age, affecting 50 million Americans, and women disproportionately. Half of all women will fracture a bone in their lifetime, according to Laura Yecies, CEO of Osteoboost, and hip fractures in old age often lead to complications or death.
Samay partners with Chiesi one year after winning MedTech Innovator
Respiratory device developer Samay and Chiesi Farmaceutici are partnering on new algorithms for the detection of a condition related to chronic obstructive pulmonary disease (COPD), the two companies will announce today.
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Time’s The Best Inventions of 2025: Ozlo Sleepbuds
Most sleep gadgets just track slumber. Ozlo’s tiny, squishy bluetooth earbuds are smarter, adjusting to your sleep. You can listen to audiobooks or playlists until accelerometers in the buds detect you’ve dozed off.
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AdvaMed Concludes Largest U.S. MedTech Conference Ever featuring Armor Medical and Wavelet
San Diego—AdvaMed, the MedTech Association, the world’s largest trade association representing medtech innovators, just concluded its most impactful MedTech Conference to date, welcoming 3,708 attendees and representatives from 1,800 companies across 38 countries.
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Averto Medical Awarded $2.1 Million NIH Grant to Advance Breakthrough Therapy for Diverticulitis
Averto Medical, a clinical-stage medical technology company pioneering gastrointestinal disease solutions, today announced it has been awarded a $2.1 million grant from the National Institutes of Health (NIH) to study its flagship product, the ColoSeal™ Intraluminal Colonic Diversion System, for a new indication: diverticulitis.
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Every Centimeter Counts: Eclipse Regenesis Gives Toddler with SBS a Second Chance
Lydia Garcia’s first two years were marked by severe medical crises, including multiple emergency operations after a twisted intestine caused most of her small bowel to die.
PharmaJet®, a World Leader in Needle-free Injection Systems, is Initiating the Development of Needle-free Self-Injection Pens for Home Use
PharmaJet®, a company that strives to improve the performance and outcomes of injectables with its enabling needle-free injection technology, today announced that it is expanding its needle-free injection portfolio with the development of a suite of proprietary, needle-free, self-injector pens.
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HeartX Cardiovascular Accelerator Announces Seven Startup Companies Selected for the 2025 Program featuring CardiaCare, CathVision, Dopl Technologies, Fibricheck, and LiveMetric
HeartX, powered by HealthTech Arkansas and MedAxiom — along with dozens of leading cardiovascular programs around the country — has selected the seven startup healthcare companies that will participate in the 2025 accelerator program.
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ACORAI Presents Positive Results in 1,600-Patient CAPTURE-HF Study for its AI-Powered Non-Invasive Multi-Sensor Platform for Improved Heart Failure Patient Management
Acorai, a clinical-stage company pioneering non-invasive hemodynamic monitoring for heart failure management, this week announced topline results from the 1,600-patient CAPTURE-HF study (Machine-Learning Estimation of Pulmonary Capillary Wedge and Right Atrial Pressures With a Non-Invasive Multi-sensor Device).
AtaCor Medical Secures $75M Financing to Support the Pivotal U.S. Study of its Extravascular ICD (EV-ICD) System
AtaCor Medical, Inc., a privately-held medical device company focused on transforming cardiac rhythm management systems, announced today that it has entered into a financing of up to $75 million.
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DermaSensor Secures $16M to Scale AI-Powered Skin Cancer Detection in Primary Care
October 2, 2025 / EINPresswire.com/ DermaSensor Inc., a medical device technology company transforming skin cancer detection for frontline care, today announced it has raised $16 million in Series B funding to fuel the commercial expansion of its FDA cleared, non-invasive skin cancer detection solution.
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Plexāā’s BLOOM⁴³ Prehab™ & Preconditioning Platform for Breast Surgery Launches in the U.S.
Plexāā, a medtech company focused on improving surgical outcomes through devices and digital products, announced today on the first day of Breast Cancer Awareness Month the U.S.
Subtle Medical Announces Strong 2025 Growth, Expands Market Leadership in AI Imaging
Subtle Medical, a global leader in AI-powered medical imaging, today announced major growth milestones, projecting 2.5x annualized revenue growth in the U.S. for 2025, fueled by strong enterprise demand and new product introductions. Their U.S. adoption now spans more than 600 installations and well over 1000 globally.
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Zenflow Receives FDA 510(k) Clearance for First-of-Its-Kind Single-Use Cystoscope
Zenflow, Inc., a medical device company developing innovative urological solutions, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Zenflow Spring® Scope & Camera Control Unit (CCU).
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Relief Cardiovascular Announces First-in-Human Procedures with World’s First Transcatheter Smart Implant for the Treatment of Congestion in Heart Failure
Relief Cardiovascular, a private company developing transcatheter smart implants to transform the treatment of heart failure, today announced the successful first-in-human use of the Relief System – the world’s first implant designed to both hemodynamically monitor and treat congestion in heart failure.
Inflammatix Announces Three Landmark Publications in Nature Medicine that Redefine Acute Infection and Sepsis Diagnosis and Treatment
SEPSIS-SHIELD study validates TriVerity™ as a breakthrough test that can transform hospital triage by providing early clarity on both infection type and illness severity
EpiWatch Announces FDA-Cleared Seizure Detection and Alerting App Now Available for Direct Download
EpiWatch, Inc. today announced that its app-based product, EpiWatch, an FDA-cleared and clinically validated mobile application for seizure detection, alerting and monitoring, is now available for direct download on the Apple App Store.
Eko Health Receives First FDA Clearance for Cardiac Foundation Model
Eko Health, a leader in AI-powered cardiac and pulmonary detection, announced today that the U.S. Food and Drug Administration has cleared its new EFAST algorithm for use within the SENSORA® platform.
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Government continues to invest in disruptive and innovative technologies with over €33 million awarded to eight additional DTIF projects featuring AuriGen Medical, CroíValve, LaNua Medical, Plio Surgical
Minister for Enterprise, Tourism and Employment, Peter Burke, and Minister for Further and Higher Education, Research, Innovation and Science, James Lawless, today announced funding of €33.1 million for eight additional projects under Call 7 of the Disruptive Technologies Innovation Fund (DTIF).
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Winter Innovations Awarded $200,000 Grant Technology Enhancement for Commercial Partnerships (TECP)
Winter Innovations, Inc has been awarded a $200,000 Technology Enhancement for CommercialPartnerships (TECP) grant from the U.S. NaConal Science FoundaCon (NSF).
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Georgia Tech Startup Sets Sights on Transforming Heart Failure Care featuring Cardiosense
“Despite advances in digital health, continuous monitoring of the heart’s mechanical function has remained difficult outside clinical settings,” said Omer Inan, researcher and entrepreneur at Georgia Tech.
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Prevencio Enters National GPO Agreement with MediGroup to Expand Access to AI-Powered Cardiovascular Blood Tests
Prevencio, Inc., a leader in AI-powered cardiovascular diagnostics, today announced a national agreement with MediGroup Physician Services, one of the largest non-acute Group Purchasing Organizations (GPOs) in the United States.
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MedTech Innovator alumni recognized on TIME’s 2025 list of the World’s Top HealthTech Companies: Alimetry, Augmedics, Bigfoot Biomedical, Eko Health, Flow Neuroscience, Forus Health, Medipixel, MindMaze, NeuroFlow, Osso VR, Sidekick Health, Subtle Medical, Wellinks
While technology has always played a role in diagnosing and treating disease, the health care industry as a whole has been slower to adopt innovative digital platforms for analyzing data to change how care is delivered.
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Healthcare On Air host Robin Goldsmith and co-host Brian Urban are joined by Ryan Meyers, Founder & CEO of CranioSense, to discuss how his team is developing what he calls the “blood pressure cuff for the brain
This episode of Healthcare On Air explores the future of brain diagnostics and what it could mean for patients globally. Host Robin Goldsmith and co-host Brian Urban are joined by Ryan Meyers, Founder & CEO of CranioSense, to discuss how his team is developing what he calls the “blood pressure cuff for the brain.”
Peerbridge Health Raises $7M, Appoints MedTech Veteran Dan Reuvers to Board
– Peerbridge Health, a company transforming how heart disease is diagnosed has closed its latest fundraising round, raising $7M to support the commercial rollout of its new product.
AccurKardia Announces Clinical Pilot Study of Its AK+ Guard ECG-based, AI-powered Hyperkalemia Detection Software
AccurKardia, an innovator in ECG-based diagnostics technology, has announced the initiation of a multicenter clinical pilot of AK+ GuardTM, an FDA Breakthrough Device Designated AI-powered technology that enables the detection of hyperkalemia using Lead I ECG.
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ClearCam Awarded Breakthrough Technology Designation Agreement with Premier, Inc.
ClearCam, Inc., an Austin-based medical device company, has been awarded a national group purchasing agreement for Breakthrough Technology with Premier, Inc.
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ZKR Orthopedics Announces First Patella LIFT™ Surgeries on the East Coast at Hospital for Special Surgery in Enrollment of FDA PELICAN Trial
ZKR Orthopedics announced today that the first Patella LIFT™ procedures on the East Coast were successfully performed as part of the PELICAN TRIAL, at the renowned Hospital for Special Surgery (HSS) in New York City.
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Raydiant Oximetry Names Michael Nagel to Lead the Company into its Device Commercialization Stage as CEO
Raydiant Oximetry, Inc., a clinical-stage medical device company developing fetal monitoring innovations using advanced biophotonics and machine learning to improve outcomes during childbirth, today announced the appointment of Michael Nagel as Chief Executive Officer.
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SutureTech Announces FDA 510(k) Clearance for RapidFix™, Its All – Suture Staple Device for Soft Tissue Repair
SutureTech, a surgeon-founded medical device company focused on advancing soft tissue and tendon repair, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for RapidFix™, its flagship device.
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Neurescue’s resuscitation device nets European approval for non-shockable cardiac arrests
Not all cardiac arrests can be treated with an electric shock. In fact, most of them—about 80%—are ineligible for defibrillation. With a survival rate of about 4%, these deaths continue to number between 7 million and 9 million per year.
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GE HealthCare inks Icometrix buyout to acquire brain MRI software
The deal includes AI-powered software for detecting known side effects of recently launched Alzheimer’s drugs.
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Asabys Partners Leads €10 Million Extension of SafeHeal’s Oversubscribed Series C Financing to Accelerate Commercialization of Colovac®
SafeHeal®, a medical device innovator transforming colorectal surgery, today announced a €10 million extension of its oversubscribed €35 million Series C financing round.
PanTher Completes First Cohort in Pancreatic Cancer Phase 1b Trial Ahead of Expectations
– PTM-101 administration in the 200 mg cohort has been completed without dose-limiting toxicity –
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Tasso, Inc. Joint Venture Receives Controlled Medical Device Approval in Japan for Novel Self-Administered Blood Collection Device
Certification clears path in Japan for wider access to preventive medicine, telemedicine, and reduced provider burden
Akeyna’s Smart Needle: Worcester Startup in Auxilium Cohort Targets Safer Injections
Karen Cronholm, the CEO of Akeyna, Inc., and part of the historic first cohort of Auxilium stops by the Talk of the Commonwealth to tell us about her business and how Auxilium is providing assistance.
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cellvie secures $5 Million in fresh capital from existing and new investors
Cellvie, a company pioneering therapeutics based on mitochondria, today announced the closing of a $5 million funding round, with participation from both existing and new investors.
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Koya Medical Receives “Building Tomorrow Together” Award from Dallas Regional Chamber
Koya Medical (“Koya”), a global leader in vascular health innovation, is proud to announce it has been honored with the Building Tomorrow Together Award by the Dallas Regional Chamber (DRC).
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MY01 Welcomes Joe Kiani as Investor and Board Member to Accelerate Innovation in Connected Patient Monitoring
MY01, an innovative medical technology company focused on transforming the diagnosis of limb perfusion injuries, today announced that Joe Kiani, founder of Masimo and a globally recognized leader in medical innovation, has invested in the company.
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OrthoPediatrics Corp. Announces Distribution Agreement with MY01 Inc.
OrthoPediatrics Corp. (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics announced today a new distribution partnership with MY01, an innovative medical technology company focused on transforming the diagnosis of limb perfusion injuries.
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Edwards buys remaining stake of Vectorious Medical Technologies and its heart implant
According to a report in Globes, Edwards Lifesciences (NYSE: EW)+ agreed to acquire the remaining stake in Vectorious Medical Technologies.
Ways to Improve Osteopenia with Osteoboost
It is exciting when new products come to market that speak directly to our demographic.
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Nutromics banks A$7.5m to make its ‘lab-on-a-patch’ device in Australia
Nutromics is developing a wearable “lab-on-a-patch” device that uses DNA biosensors and microneedles to capture continuous, real-time molecular data.
Inflammatix Data in Journal of Clinical Microbiology Validate Accuracy, Robustness, and Ease of Use of TriVerity™ Test System
Inflammatix, a pioneering host response diagnostics company, today announced the publication of analytical data in the Journal of Clinical Microbiology (JCM) that validate the benefits of the TriVerity™ Test System (TriVerity), a first-in-class molecular blood test to help emergency department (ED) physicians quickly and accurately triage patients with suspected acute infection or sepsis.
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EQT Life Sciences Leads USD 44 Million Series B Financing in Cyted Health to Accelerate US Expansion
EQT Life Sciences is pleased to announce that the EQT Health Economics strategy has invested in Cyted Health, a leading gastrointestinal (GI) molecular diagnostics company.
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Catherine Liao named Woman of the Year at Best of Sensors featuring CardieX
Catherine Liao is well-known to the sensors universe as a passionate technologist and entrepreneur. At this year’s Best of Sensors Awards, she also earned the distinction of Woman of the Year.
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Plexāā Joins JLABS EMEA
Plexāā is thrilled to announce that they have joined Johnson & Johnson’s global incubator network, JLABS, as a virtual member company of JLABS EMEA. This marks a meaningful step in Plexāā’s mission to help patients prehabilitate and precondition before surgery through the power of supraphysiological preconditioningTM which has been shown to reduce wound healing complications in proof-of-concept clinical trials.
Eko Health to Participate in Upcoming Baird and Morgan Stanley Global Healthcare Conferences
Eko Health, a leader in AI-powered cardiac and pulmonary detection, today announced its participation in two upcoming investor conferences:
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Newrotex Achieves World-First Implantation of SilkAxons™ Nerve Repair Technology, Pioneering a New Frontier for Large-Gap Peripheral Nerve Injuries
Oxford, UK and Panama City, Panama — Newrotex Ltd., an Oxford-based medical technology company, today announced the successful first-in-human implantation of its flagship nerve repair technology, SilkAxons™.
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Virginia’s Biggest Business Bash: Startup World Cup Virginia Finals 2025 featuring Luminoah
They will go on to represent Virginia at the global finals in San Francisco, competing against the world’s top startups for the $1 million grand prize. Their bold vision and relentless execution wowed both the judges and the audience, proving that Virginia innovation is ready for the world stage.
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Belfast-based Neurovalens closes £6m funding round
Belfast-based neurotechnology company Neurovalens has closed a £6 million (€6.95 million) investment round to help fund its commercial expansion in the US and global markets.
UWA invests $1m in OncoRes Medical, as company enters final stretch of FDA pitch
The University of Western Australia has invested $1 million into Perth-based medtech company OncoRes. The investment is UWA’s first in one of its 25 spinout companies.OncoRes chief executive Dr Katharine Giles said the investment would be welcomed as it moves towards potential US Food and Drug Administration approval of its Elora precision cancer imaging technology.
Cohesys Announces First-in-Human Use of Investigational BoneTape™ in Craniofacial Fracture Repair
Cohesys Inc., a Toronto-based medical device developer of resorbable fixation technologies, today announced that the first participants have undergone treatment with BoneTape™, an investigational device designed for the fixation of non-load-bearing craniofacial fractures.
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SafeHeal® Receives European Marketing Approval Under MDR for Colovac® Anastomosis Protection Technology
SafeHeal®, a leading innovator in the field of colorectal cancer surgery, today announced that it has been granted European Union marketing approval for its Colovac device under the new Medical Device Regulation (EU MDR 2017/745, Medical Devices, Annex IX Chapter I).
RIVANNA secures $800,000 Virginia Catalyst Grant alongside matching funds to advance AI-enabled ultrasound platform for neuraxial anesthesia
RIVANNA®, developers of world-first imaging-based medical technologies, was recently awarded grant funding valued at $800,000 from the Virginia Catalyst Program to advance the Accuro® 3S diagnostic ultrasound system.
Lungpacer Announces CMS NTAP Approval for AeroPace® System in FY2026 IPPS Final Rule
Lungpacer Medical Inc., a medical technology company focused on neurostimulation therapies for critically ill patients, today announced that the Centers for Medicare & Medicaid Services (CMS) has granted New Technology Add-on Payment (NTAP) status for the AeroPace® System under the Fiscal Year 2026 Inpatient Prospective Payment System (IPPS) Final Rule, effective October 1, 2025.
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Cardiosense pairs advanced sensors with AI for its heart failure wearable
Dr. John Martin has a special perspective on medical device development as a practicing surgeon, medical device executive, and a patient who once found cancer in his own body while testing Butterfly Network’s technology.
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Following FDA Announcement, Teal Health’s Teal Wand™ for At-Home Cervical Cancer Screening is Now Available, Starting in California
Teal Health®, a virtual women’s health company on a mission to eliminate cervical cancer, today announced the general availability of their Teal Wand™ for at-home cervical cancer screening kit and virtual telehealth services in California.
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Blindspot Capital features Momm Diagnostics: Can We Finally Detect Preeclampsia Before It’s Too Late?
In this episode, healthcare investor and strategist Maryann Umoren Selfe is joined by Matthias Wipf, CEO of Swiss medtech company Momm Diagnostics, to examine the systemic gaps in how we identify and fund life-saving healthcare infrastructure for women.
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SafeBeat Awarded $2M SBIR Grant to Advance AI-based ECG Analysis for Mobile Therapeutic Monitoring of Atrial Fibrillation Patients: Clinical Study at University of California San Francisco
SafeBeat announced today it has been awarded a Direct to Phase Il Small Business Innovation Research (SBIR grant for approximately $2M from the National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH).
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EvoEndo Endoscopy System Receives FDA Clearance for All Ages
EvoEndo Inc. has announced that the EvoEndo Model LE Gastroscope is now FDA-cleared for patients of all ages — from neonates to adults. Since 2022, the EvoEndo System has been the only option available for sedation-free transnasal endoscopy for pediatric patients five and older.
Inflammatix’s TriVerity™ Test Secures NTAP Reimbursement from CMS for First-in-Class Severity Score Working in Concert with Bacterial and Viral Insights
Inflammatix, a leader in host-response diagnostics, today announced that its TriVerity™ Test has been granted New Technology Add-On Payment (NTAP) reimbursement by the Centers for Medicare & Medicaid Services (CMS) for fiscal year 2026.
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Founder Spotlight: Dan Clark, Co-Founder & CEO of Linear Health Sciences
In this Founder Spotlight, we talk to Dan Clark, Co-Founder and CEO of Linear Health Sciences, about the journey behind creating life-saving medical devices like the Orchid Safety Release Valve.
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Cardiosense wins FDA clearance for wearable sensor
Cardiosense announced today that it received FDA 510(k) clearance for its CardioTag wearable sensor device.
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BARDA awards nearly $10 million to RIVANNA to accelerate development of CADe/x AI module for Accuro XV
RIVANNA®, developers of imaging-based medical technologies, announced that it received $9.92 million in federal funding of a contractual option from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S.
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Embolx Launches Sniper G3: Revolutionizing Embolization with Enhanced Efficiency, Ease of Use, and Extended Shelf Life
Embolx, a leader in advanced microcatheters for targeted embolization procedures, today announced the release of its next-generation Sniper G3 Balloon Occlusion Microcatheter.
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New Research Validating VeraBIND™ Tau Assay as Accurate Blood Test for Active Tau Pathology in Alzheimer’s Disease Presented at the 2025 Alzheimer’s Association International Conference featuring Veravas Inc.
Veravas Inc., an innovator in diagnostics dedicated to advancing health outcomes through early disease detection, announced that two independent analyses, presented at the 2025 Alzheimer’s Association International Conference (AAIC), demonstrate that the VeraBIND Tau assay accurately measures active tau pathology—a key biomarker of Alzheimer’s disease (AD) and other tauopathies—in individuals with and without cognitive impairment.
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Powerful Medical Receives €40 Million Non-Dilutive Grant to Accelerate Early Diagnosis of Cardiovascular Diseases with AI
Powerful Medical, a leader in AI-driven cardiovascular diagnostics, has been selected to receive over €40 million (USD $46 million) in non-dilutive grant funding through the European Commission’s IPCEI Tech4cure project initiative.
This Medtech Platform Started with a DARPA Mission – Now It’s Tackling Brain Bleeds and Trauma featuring Arsenal Medical
Some medtech innovations don’t come from tweaking devices—they come from rethinking materials themselves.
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BRIJ Medical, Inc. and Red One Medical, LLC Secure ECAT Listing for Brijjit® via SDVOSB partnership
BRIJ Medical, Inc., a medical device company redefining surgical closure and post-surgical healing, and Red One Medical, LLC – a CVE-certified Service-Disabled Veteran-Owned Small Business (SDVOSB) – are proud to announce that Brijjit® (BP-100 and BP-75) is now available through the ECAT (the electronic catalog).
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Cooler Heads secures $11M for portable scalp cooling system
San Diego-based Cooler Heads, a medical device company specializing in products for cancer patients, announced it closed an oversubscribed $11 million Series A funding round.
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Prevencio Enters Canadian Market Through Strategic Partnership with Heart Fit Clinic
Prevencio, Inc., a pioneer in AI-powered cardiovascular diagnostics, today announced a strategic partnership with Heart Fit Clinic, Canada’s foremost network of preventive cardiology centers.
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The Dallas Healthtech Founder Launching a Wearable Stroke Detection Breakthrough featuring Alva Health
Sandra Saldana wants to detect strokes before patients sense they are having one, preventing disability and saving lives along the way. Her company, Alva Health, recently received a big boost toward that goal when it received validation and funding from the National Science Foundation.
NEMBO-02 study indicates rapid cSDH resorption and pain-free treatments with NeoCast liquid embolic agent featuring Arsenal Medical
Arsenal Medical has announced late-breaking data from the EMBO-02 clinical study evaluating NeoCast—a next-generation, shear-responsive liquid embolic agent—in the treatment of patients with chronic subdural haematoma (cSDH) via middle meningeal artery embolisation (MMAe).
TechRound listed OncoRes Medical as a “Top 10 MedTech Startups in Australia 2025” for its intraoperative cancer imaging probe and AI-powered surgical guidance system
OncoRes Medical has been named one of TechRound’s Top 10 MedTech Startups in Australia 2025.
Nanochon Announces Health Canada Approval for First in Human Investigation
Nanochon, a Washington, DC and Baltimore, MD-based orthopedic device biotech company developing an implant for treating articular cartilage defects in the knee, is thrilled to announce that it was granted Health Canada Approval for their first in human clinical trial.
Eko Telehealth Powers Virtual Cardiac and Pulmonary Exams for Health Systems Operating Over 800 U.S. Hospitals
Eko Health, a leader in AI-powered cardiac and pulmonary care, announced today that its telehealth platform is now used by health systems that operate over 800 hospitals across the U.S.
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Newrotex Receives Rapid Regulatory Approval in Panama for First-in-Human Trial of SilkAxons™ Nerve Regeneration Technology
Newrotex Limited has received regulatory approval for its first-in-human clinical trial of SilkAxons™, an advanced bioengineered nerve guide designed to repair severe peripheral nerve injuries.
GT Medical Technologies Completes Final Close of Company’s Oversubscribed $53 Million Series D Equity Financing to Advance Commercial Treatment for Patients with Operable Brain Tumors
GT Medical Technologies, Inc., a medical device company dedicated to improving the lives of patients with brain tumors, today announced the company has completed the close of its oversubscribed $53 million Series D equity financing.
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2026 Medicare Physician Fee Schedule Rates Set for Scalp Cooling CPT Codes
Cooler Heads, a health tech company dedicated to making scalp cooling more accessible and affordable for people undergoing chemotherapy, celebrates a major milestone in the effort to expand access to their hair-preserving treatment.
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Noninvasive Pulmonary Capillary Wedge Pressure Estimation in Heart Failure Patients With the Use of Wearable Sensing and AI featuring Cardiosense
Remote hemodynamics-guided management of heart failure (HF) with implantable pulmonary artery pressure sensors has been shown to reduce HF hospitalizations.
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Hypervision Surgical receives FDA Clearance for HYPERSNAP® Surgical System to improve patient safety
Hypervision Surgical (“Hypervision”) proudly announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the HYPERSNAP® Surgical System — the first intraoperative platform to combine Hyperspectral Imaging (HSI) with AI-powered analytics for real-time surgical decision support.
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Brain implants without a hole in your skull featuring Vonova
Wes Jones is the CEO of Vonova, a brain computer interface company that (unlike Neuralink) is enabling access to the brain without drilling a hole in your skull. Wes joins Brom Rector and Sam Tabone on the Human 3 podcast.
PharmaJet® Enters into MOU Agreement with Egyptian UPA and EVA Pharma to provide Needle-free Delivery for Routine Immunization in Egypt
PharmaJet®, a company that strives to improve the performance and outcomes of injectables with its enabling needle-free injection technology, today announced that it has signed a Memorandum of Understanding (MOU) agreement with the Egyptian Unified Procurement Authority (UPA) and EVA Pharma, one of the leading pharmaceutical companies driving healthcare innovation and access across the Middle East and Africa, to explore the integration of needle-free delivery of inactivated polio vaccine into Egypt’s routine immunization program.
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Solenic Medical Appoints Medical Device Industry Veteran Bart Bandy as Chief Executive Officer
Solenic Medical, a leading innovator focused on revolutionizing orthopedic implant infection care, announced today the appointment of Bart Bandy as its new Chief Executive Officer.
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Newrotex Receives Rapid Regulatory Approval in Panama for First-in-Human Trial of SilkAxons™ Nerve Regeneration Technology
Newrotex Limited has received regulatory approval for its first-in-human clinical trial of SilkAxons™, an advanced bioengineered nerve guide designed to repair severe peripheral nerve injuries.
Eko CORE 500® Wins Prestigious Red Dot Design Award for Product Innovation
Eko Health, a leader in artificial intelligence (AI) for the early detection of heart and lung diseases, today announced that its CORE 500® Digital Stethoscope has been awarded the internationally recognized Red Dot Design Award for product design excellence.
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Plexāā Closes $4.5 Million Funding Extension to Drive U.S. Launch of BLOOM43 Platform for Breast Surgery
Plexāā, a MedTech startup behind the award-winning BLOOM43 medical device for breast surgery, has announced the close of a $4.5 million funding extension round.
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PanTher Therapeutics Initiates Phase 1b clinical trial of absorbable, long-lasting, high-dose chemotherapy patch for pancreatic cancer
PanTher Therapeutics (“PanTher” or the “Company”), a clinical-stage company redefining cancer treatment with therapeutics administered continuously and exclusively at the tumor site, today announced that the first patient has been treated with PTM-101 in a Phase 1b clinical trial in pancreatic ductal adenocarcinoma (PDAC).
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Samsung acquiring Seattle tech startup Xealth to boost digital health ambitions
Samsung Electronics is acquiring Seattle-based digital health startup Xealth, aiming to expand its footprint in healthcare. Founded in 2017 as a spinout of the Providence health system, Xealth helps healthcare providers prescribe and manage digital health tools.
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Cedars-Sinai backs AI startup featuring Dasi Simulations
Cedars-Sinai Ventures is investing in an AI startup focused on structural heart care, Columbus (Ohio) Business First reported. The venture capital arm of the Los Angeles-based health system participated in a $5 million funding round in June for Dasi Simulations, which uses AI for predictive modeling, according to the July 3 story.
Moon Surgical Receives FDA Clearance for Maestro™ Connectivity and Predetermined Change Control Plan for AI-Powered ScoPilot®
Moon Surgical, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for two major advancements to its Maestro System: connectivity of the platform to power the Maestro Insights product and a Predetermined Change Control Plan (PCCP) to evolve its AI-powered ScoPilot product.
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DLA Piper advises ImmersiveTouch in its strategic investment by HealthpointCapital
DLA Piper advised ImmersiveTouch, a leading digital surgery company, in its strategic investment by HealthpointCapital, a private equity firm focused exclusively on musculoskeletal healthcare to acquire a majority of the equity interests of the company.
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CroíValve Announces Funding from Horizon Europe EIC Accelerator
CroíValve, a pioneering medical device company innovating a better way to help more patients suffering from Tricuspid Regurgitation (TR), was awarded funding from Horizon Europe’s European Innovation Council (EIC) Accelerator Programme.
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InterShunt initiates study of device for heart failure treatment
InterShunt Technologies has initiated the EASE HF2 early feasibility study to assess the InterShunt percutaneous atrial shunt catheter (PAS-C) system, intended to alleviate symptoms of heart failure and enhance the quality of life for patients.
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Demonstration of Biomechanical Safety When Applying a Flowable Hydrogel Tendon Protector: A Cadaver Study featuring TYBR Health
B3 GEL™ SYSTEM SUPPORTING RESEARCH: What Happens When You “Overapply” Tendon Protection?
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Breakthrough in Cancer Care: Multi4 Medical’s New Technology Cleared by FDA
Swedish MedTech company Multi4 Medical, chaired by renowned investor Erik Selin, has received FDA clearance for its patended technology for automated cancer treatment. The decision means that Multi4 is now approved for commercial sale in the U.S., the world’s largest and most competitive healthcare market.
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HealthpointCapital Acquires ImmersiveTouch, Inc., a Leading Extended Reality Surgical Platform
HealthpointCapital, the leading private equity firm focused exclusively on musculoskeletal healthcare, today announced the acquisition of a majority stake in ImmersiveTouch, Inc. (“ImmersiveTouch” or the “Company”).
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Neurent Medical Announces Expanded Access Following Cigna Policy Update for NEUROMARK®
Neurent Medical, a leader in non-surgical treatments for chronic rhinitis, today announced that Cigna Healthcare will provide coverage for NEUROMARK treatment of the posterior nasal nerve by removing CPT 31242 posterior nasal nerve ablation using radiofrequency from its Experimental & Investigational (E&I) list, effective September 15th, 2025.
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InterShunt Enrolls First Patient in New Heart Failure Study
InterShunt Technologies, Inc., a medical device company focused on developing minimally invasive treatments for heart failure, has officially kicked off its latest clinical study, the EASE HF2 Early Feasibility Study, which is evaluating a device designed to reduce heart failure symptoms and improve quality of life.
STENTiT Enrolls First Patient in Clinical Trial Evaluating a Novel Stent with Regenerative Properties to Support Limb Preservation
STENTiT, a pioneering medical device company, developing a novel class of stents with regenera6ve proper6es, today announced the successful implanta6on of its Resorbable Fibrillated Scaffold (RFS).
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Emerging technologies in healthcare, part 7: Lattice Medical
Lattice Medical has created a 3D-printed, resorbable implant called MATTISSE, designed to use an oncology patient’s own fat tissue to regenerate one’s breast after undergoing a mastectomy.
PharmaJet® and Immuno Cure Sign Agreement for Clinical Development of a Needle-free HIV Therapeutic DNA Vaccine
PharmaJet®, a company that strives to improve the performance and outcomes of injectables with its enabling needle-free injection technology, today announced that it has entered into an agreement with Immuno Cure, a prominent developer of DNA vaccines.
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Neuspera Medical Receives FDA Approval for First Integrated Sacral Neuromodulation (iSNM) System for Urinary Urge Incontinence
Neuspera® Medical, Inc., the leading developer of integrated technologies powering the future of neuromodulation, today announced that the U.S. Food and Drug Administration (FDA) has approved its integrated sacral neuromodulation (iSNM) system for the treatment of urinary urge incontinence (UUI).
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Mount Sinai adopts Flosonics wearable ultrasound device
Flosonics announced today that Mount Sinai Hospital has adopted FloPatch, its wireless Doppler ultrasound device.
Backed by $2 Million, Droplet IV is Set to Launch its Revolutionary Automatic IV-Line Flushing Device in EU & US in 2026
Droplet IV today announced the successful completion of a $2 million funding round to enable launch of its first automatic IV-line flushing device in the EU and US markets.
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bioMérieux strengthens its next-generation sequencing capabilities with the acquisition of Day Zero Diagnostics solutions and technologies
BioMérieux, a world leader in the field of in vitro diagnostics, announces an agreement to acquire the assets of Day Zero Diagnostics, a US-based infectious disease diagnostics company using genome sequencing and machine learning to combat the rise of antibiotic-resistant infections.
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Alva Health Wins $500,000 in R&D Funding from the U.S. National Science Foundation
Alva Health, a medical device company pioneering wearable solutions for early stroke detection, has been awarded $500,000 from the U.S. National Science Foundation (NSF) Small Business Innovation Research (SBIR) Phase IIB program to conduct research and development on the company’s flagship product: a discreet, wrist-worn system designed to detect stroke symptoms in real time and enable faster access to emergency care.
Moon Surgical Discusses Maestro at NVIDIA GTC Paris, Celebrating 1,300+ Procedures in the Past Year and the Power of Physical AI
Moon Surgical, the French-American leader in Physical AI for the operating room, today announced its participation at NVIDIA GTC Paris during VivaTech2025.
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Neurent Medical Announces 510(k) Clearance of its Next Generation NEUROMARK® System
Neurent Medical, a leader in pioneering non-surgical solutions for chronic sino-nasal inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Next Generation NEUROMARK® System, marking a major milestone in advancing care for patients suffering from Chronic Rhinitis.
Huntsville Memorial Hospital Reduces Patient Transfers and Enhances Local Care with Onsite EEG Program Powered by Zeto
Zeto, Inc. is proud to announce the success of a new onsite EEG program at Huntsville Memorial Hospital (HMH) that has helped reduce emergency room patient transfers and improve access to neurological diagnostics for the Huntsville community and surrounding areas.
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TEDCO Invests in NanoBioFAB
TEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 Pre-Seed Builder Fund investment in NanoBioFab. The Pre-Seed Builder Fund invests in and provides executive support to Maryland-based technology companies run by entrepreneurs who demonstrate economic disadvantages.
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Prevencio Awarded U.S., European and Japanese Patents for HART CADhs, Its AI-Driven Blood Test for Coronary Artery Disease
Prevencio, Inc., the leader in artificial intelligence-powered blood tests for cardiovascular disease, today announced that it has been granted patents for its HART CADhs® test in the United States—marking the second U.S.
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California Transplant Koya Medical Opens New HQ in Dallas Design District
Koya Medical, a medical device company focused on vascular health innovation, has completed its HQ relocation from Oakland, California, by opening its new headquarters in the Dallas Design District.
Inflammatix Names Martín Vazquez as Chief Operating Officer to Drive National Scale-Up of TriVerity™ Test System
Inflammatix, a leader in AI-powered immune response diagnostics, today announced the appointment of Martín Vazquez as chief operating officer (COO). The hire marks a major milestone in the company’s commercial expansion as its flagship TriVerity™ Test System gains traction among U.S. hospitals.
Boehringer Ingelheim and Eko Health Inc. enter digital health collaboration to improve heart murmur detection in dogs
Ingelheim, Germany, and San Francisco, Calif., June 10, 2025 | Boehringer Ingelheim, a global leader in animal health, and Eko Health, a pioneer in applying artificial intelligence (AI) for early detection of heart and lung diseases, have entered a strategic collaboration agreement.
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Cleveland Clinic is First to Use Wireless, Catheter-Free Device to Monitor Bladder Dysfunction in Patients featuring Bright Uro
Cleveland Clinic is the first to use the Glean™ Urodynamics System, the first wireless, catheter-free method of urodynamic monitoring following 510(k) clearance from the U.S. Food and Drug Administration in March.
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TYBR Health Announces FDA 510(k) Clearance for B3 GEL™ System, a Flowable Bio-Gel to Protect Healing Tissue and Preserve Function
TYBR Health, a medical device and regenerative medicine company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the B3 GEL™ System.
LEADOPTIK Awarded Key Patents Across Three Continents
LEADOPTIK Inc., a Silicon Valley-based medical imaging company, today announced it has been awarded key patents for its proprietary optical probe across three continents: North America, Europe, and Asia.
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FineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France
Patients with advanced heart failure will be treated with FlowMaker®, an innovative, fully implantable device for restoring cardiac output.
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Introducing Fierce Medtech’s Fierce 15 featuring Averto, Distalmotion, and Model Medicines
Averto Medical, Distalmotion, and Model Medicines were featured in Fierce Medtech’s Fierce 15.
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Maryland Comptroller Brooke Lierman Honors AAPI Business and Community Leaders featuring Nanobiofab
Maryland Comptroller Brooke Lierman presented the inaugural Asian American and Pacific Islander (AAPI) Heritage Awards to 15 distinguished AAPI business owners and community leaders during a ceremony held on May 28, 2025, at the Louis L. Goldstein Treasury Building in Annapolis.
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CoapTech Raises New Funding Round Led by Good Growth Capital
CoapTech Inc., a Baltimore-based medical device company, announced today the initial close of a Series B funding round, which was led by Good Growth Capital, an early-stage venture capital firm that invests in transformative science and technology, with participation from the University System of Maryland (USM) Momentum Fund (Momentum Fund) and the University of Maryland, Baltimore (UMB), a previous investor.
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Salvia BioElectronics secures $60M in oversubscribed Series B to bring its pioneering migraine therapy to market
Eindhoven, the Netherlands, May 27, 2025: Salvia BioElectronics, a clinical-stage medical device company pioneering neuromodulation therapy for people with chronic migraine, today announced the successful completion of a $60 million (€53 million) Series B financing round.
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Gradient’s Pulmonary Artery Denervation System Receives FDA Breakthrough Designation
Gradient Denervation Technologies, which is based in Paris, France, announced that the company’s pulmonary artery denervation (PADN) system has received FDA Breakthrough Device designation.
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PhotoniCare’s OtoSight Demonstrates More Accurate Diagnosis and a 50 Percent Reduction in Antibiotic Usage for Pediatric Ear Infections in Large Randomized Controlled Trial
PhotoniCare Inc., a medical device company dedicated to delivering innovation to frontline care that demonstrably enhances patient outcomes, is pleased to announce its progress in the diagnosis and treatment of pediatric ear infections that affect more than 80 percent of children by age three, account for millions of visits to the pediatrician each year, and are the leading cause of antibiotic use in children.
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UK’s Huma expands US Presence with Aluna acquisition, launches M&A partnership with Eckuity Capital
London-based healthtech unicorn Huma is accelerating its growth by acquiring US respiratory health startup Aluna, and a new strategic partnership with Eckuity Capital to support a broader M&A strategy.
CoapTech Receives 510(k) Approval for its PUMA-G Pediatric device!
The PUMA-G Pediatric device is now cleared by the U.S. FDA for use in children. This device will enable an ultrasound-based gastrostomy procedure for kids, with the potential to reduce radiation, sedation, procedure time, scarring, and infections while greatly expanding the accessibility of gastrostomy procedures for children worldwide.
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Prevencio Receives FDA Breakthrough Device Designation for HART CADhs, Its Artificial Intelligence-driven Blood Test for Obstructive Coronary Artery Disease
Prevencio, Inc., the leader in artificial intelligence-powered blood tests for cardiovascular diagnostics, announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its HART CADhs® test.
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GE HealthCare and Raydiant Oximetry accelerate innovation in fetal oxygen saturation technology
GE HealthCare (Nasdaq: GEHC) and Raydiant Oximetry, Inc. today announced a joint development initiative to enhance fetal monitoring capabilities that could strengthen the support of clinical decision-making during labor.
FDA Approves Teal Health’s Teal Wand™—The First and Only At-Home Self-Collection Device for Cervical Cancer Screening, Introducing a Comfortable Alternative to In-Person Screening
Teal Health®, a women’s health company on a mission to eliminate cervical cancer, today announced the Food and Drug Administration’s (FDA) approval of the Teal Wand™, the first and only at-home vaginal sample self-collection device for cervical cancer screening in the United States.
AccurKardia’s AccurECG Named “Best New Technology Solution for ECG” in 9th Annual MedTech Breakthrough Awards Program
AccurKardia, an innovator in ECG-based diagnostics technology, today announced that its AccurECGTM software platform has been selected as winner of the “Best New Technology Solution for ECG”
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PATH EX, Inc. Announces Successful $5 Million Financing Round to Advance CycloPE(R), a Breakthrough Treatment for Sepsis
PATH EX, Inc., a medical device company located in the Texas Medical Center Innovation Factory, is excited to announce the successful completion of a $5 million financing round.
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Bobby Reddy Jr from Presnosis makes TIME’s 100 list
Every year in the U.S., about 6% of emergency room visits are due to sepsis, an extreme immune system reaction to infection that can lead to organ failure and death in a short period of time.
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Conavi Medical’s Novasight Hybrid™ System Named “Product Innovation of the Year” at 2025 Minnesota Manufacturing Awards
Conavi Medical Corp. (TSXV: CNVI; OTCQB: CNVIF) (“Conavi Medical” or the “Company”), a medical device company focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures, today announced that its Novasight Hybrid™ System (“Novasight”) has been named “Product Innovation of the Year”
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INBRAIN Neuroelectronics Awarded €4 Million Grant from Spain’s PERTE Chip Program to Advance Graphene-Based Brain-Computer Interfaces
INBRAIN Neuroelectronics, a clinical-stage neurotechnology company developing precision brain-computer interfaces (BCIs) powered by graphene, announced today it has been awarded a €4 million grant by the Spanish Ministry of Industry and Tourism through the PERTE Chip initiative.
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Zetagen Therapeutics Announces Successful Completion of Enrollment in Phase 2a Clinical Study of ZetaMet™ (Zeta-BC-003) Metastatic Breast Cancer
Zetagen Therapeutics, Inc., a private, clinical stage, biopharmaceutical company focused on developing breakthrough therapies, via local administration, for metastatic and primary breast cancers, announced today they have successfully completed enrollment in their phase 2a study, which will evaluate ZetaMet™ (Zeta-BC-003) in the treatment of spinal metastatic lytic breast cancer lesions (ClinicalTrials.gov #NCT05280067).
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SafeHeal nets $40m to advance endoluminal bypass sheath
SafeHeal has pulled in €35m ($39.7m) in Series C equity financing to validate its Colovac endoluminal bypass system.
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Iceland: Sidekick Health Secures €35 Million Venture Debt from EIB to Accelerate R&D and Global Expansion
The European Investment Bank (EIB) and Sidekick Health — a global leader in integrated digital health and therapeutics — today announced the signing of a €35 million venture debt facility, backed by a dedicated life science venture debt window of the European Commission’s InvestEU programme.
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Vonova’s Successful Seed Financing for Revolutionary Brain Access Technology
Vonova Inc. has secured seed financing from a consortium of investors including XEIA, Device of Tomorrow Capital, and SmartGate VC. This investment milestone represents significant market validation for Vonova’s Cerebro Clear system, which includes a revolutionary endovascular platform that provides access to the brain without drilling through the skull.
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Sonavex Receives FDA 510(k) Clearance for EchoMap™ Device
Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced today that it has received U.S.
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Zenflow announces Spring System data for benign prostatic hyperplasia
Medical device company Zenflow has reported that its Spring System demonstrated durable benefits three years post-placement for individuals with benign prostatic hyperplasia (BPH) in the ZEST pilot studies.
Early cancer detection startup Craif raises $22M
Cancer ranks as one of the top causes of death worldwide. The National Cancer Institute reported nearly 20 million new cancer cases and 9.7 million cancer-related deaths globally in 2022, with projections showing a rise to 29.9 million new cases by 2040.
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Biolinq Announces Close of $100M Series C Financing to Advance Its Biowearable Platform for Metabolic Health
Biolinq Incorporated, a healthcare technology company pioneering precision multi-analyte biosensors to improve metabolic health, today announced a $100 million Series C financing led by Alpha Wave Ventures, with participation from existing investors RiverVest Venture Partners, AXA IM Alts, LifeSci Venture Partners, M Ventures, Hikma Ventures, Aphelion Capital, Taisho Pharmaceutical and Features Capital.
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Prapela, Inc. Granted FDA De Novo for Breakthrough Therapy Helping the Most Vulnerable Victims of our Opioid Epidemic
One of the more sorrowful consequences of our opioid crisis is the use of opioids among pregnant women and their impact on newborns. Prenatal opioid exposure (POE) can result in a postnatal withdrawal condition in newborns called neonatal opioid withdrawal syndrome (NOWS).
Approval Through FDA’s De Novo Pathway: A Major Accomplishment! featuring Osteoboost
In January 2024, Osteoboost achieved a notable regulatory milestone by receiving De Novo classification from the U.S. Food and Drug Administration (FDA).
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Cutting Edge At-Home MedTech and Digital Health Companies, Satio and Nanowear, to Collaborate on Accelerating Non-invasive Biomarkers, Diagnostics and Drug Delivery, Beyond the Remote Monitoring and Digital Assessment Tools Used Today
Satio and Nanowear have agreed to partner to advance patient-friendly, home-based diagnostic, and therapeutic care. This collaboration integrates Nanowear’s at-home AI-based nanotechnology biomarker diagnostic platform with Satio’s at-home blood draw diagnostics and drug delivery systems/patches: combining time synchronous, in vivo and in vitro diagnostics for precision therapeutics and individualized AI-based risk assessment.
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X-Bolt Trauma Orthopedics: Interview With Founder & CEO Dr. Brian Thornes About The Trauma Surgery Improvement Company
X-Bolt Trauma Orthopedics is a company that brings simplicity and efficiency to trauma surgery, whilst improving quality of life for patients. Pulse 2.0 interviewed X-Bolt Trauma Orthopedics founder and CEO Dr. Brian Thornes to learn more about the company.
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Innoblative Receives U.S. IDE Approval for its Novel Electrosurgical Device for Breast Cancer Treatment
Innoblative Designs, Inc. (Innoblative), a private medical device company addressing clinical unmet needs for patients with breast cancer, announced today that the U.S.
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Puzzle Medical Devices Announces Closing of CAD 43 Million Funding Round to Complete Clinical Study Led by KF Matheson and Desjardins Capital
Montreal-based startup Puzzle Medical Devices announced today the closing of a CA$43 million funding round. This round, led by KF Matheson and Desjardins Capital , with participation from Lumira Ventures , Longview Ventures , BDC Capital and existing investors, is one of the largest medical device rounds in Canada in the past two years.
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Ypsomed and Sidekick Health launch a collaborative digital health solution for obesity management
Ypsomed and Sidekick Health are launching an integrated digital health solution to better support people with obesity. Ypsomed’s autoinjectors seamlessly integrate into Sidekick’s digital health and chronic condition support app to help patients using GLP-1-based injectable therapies manage their treatment more effectively.
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Healionics Granted US Patent for STARgraft Technology
Healionics Corporation, a developer of synthetic biomaterial-based medical devices, today announced that the U.S. Patent and Trademark Office has issued patent no.
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Makani Science Receives FDA Clearance for Groundbreaking Respiratory Monitor
Makani Science, an innovator in wearable respiratory monitoring technology, today announced that it has achieved 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market and distribute its Makani Respiratory Monitor.
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Bright Uro Receives FDA Clearance for Glean™ Urodynamics System
Bright Uro, a medical device company with a mission to transform care for lower urinary tract dysfunction (LUTD) through innovations in urodynamics, today announced that the U.S.
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Zeto Unveils NeuroPulse, the First AI-Powered Status Epilepticus Software Using Full 10-20 EEG in Collaboration with encevis
Zeto, Inc., a fast-growing medical technology company revolutionizing EEG diagnostics with its cutting-edge devices and advanced cloud platform, announces the integration of live bedside AI-powered Seizure Burden and Status Epilepticus detection.
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Avisi Technologies Presents Positive Six-Month Clinical Data for VisiPlate® Aqueous Shunt at the American Glaucoma Society
Avisi Technologies, a clinical-stage ophthalmic device company, today announced encouraging six‐month interim results from the VITA trial evaluating its VisiPlate® device, an ultrathin, multichannel aqueous shunt in study subjects diagnosed with open-angle glaucoma.
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FDA grants expanded 510(k) clearance for Epitel’s wireless EEG system
The US Food and Drug Administration (FDA) has granted expanded 510(k) clearance for Epitel’s REMI Wireless electroencephalogram (EEG) System for neurological monitoring in infants and paediatric patients aged one year and above.
Caretaker Medical Receives Inaugural Healthcare Tech Innovation Award and $200,000 Grant from Medical Society of D.C.
Caretaker Medical is honored to announce it has been awarded the Healthcare Technology Innovation Award, along with a $200,000 grant, from the Medical Society of the District of Columbia (MSDC) at the 5th annual Capital Healthcare Honors Gala.
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NBL and Tasso, Inc. to Establish Joint Venture in Japan
TOKYO & KAGOSHIMA, Japan & SEATTLE – Tokyo & Kagoshima, Japan (March 28, 2025 JST) / Seattle, Washington, USA (March 27, 2025 PT): Shin Nippon Biomedical Laboratories, Ltd.
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Agreement Between Varian and Embolx Paves the Way for Advanced Image-Guided Therapies for Cancer
Varian, a Siemens Healthineers company, announced a U.S. co-marketing and sales agreement with Embolx for the sale and market development of the Sniper Balloon Occlusion Microcatheter.
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Distalmotion Announces Acquisition of its DEXTER® Robotic Surgery System by the First Ambulatory Surgery Center in the US
Northtowns Ambulatory Surgery Center (ASC), a joint venture between Buffalo surgeons and Kaleida Health Ventures, has chosen Distalmotion’s DEXTER® Robotic Surgery System as its outpatient surgical robot of choice, marking a major milestone in expanding access to robotic surgery by addressing existing barriers to surgical robotics in outpatient care.
OncoRes Medical was featured on Nine News, showcasing the groundbreaking Elora device
OncoRes Medical was featured on Nine News, showcasing our groundbreaking Elora device that helps surgeons identify cancerous tissue during breast cancer removal surgeries.The story took viewers inside our Perth headquarters where CEO Kath Giles demonstrated how this innovative technology works to dramatically reduce the need for multiple surgeries – a game-changer for breast cancer patients worldwide.
Inflammatix Ships TriVerity™ Test Cartridges and Myrna™ Instruments to the U.S. Military
Inflammatix receives an initial $1.2 million to cover the first phase of system evaluation, with future phase options worth up to $20.8 million
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Morningside Ventures Makes Strategic Investment in Xealth to Accelerate Digital Health Ecosystem
Xealth, the leader in digital health enablement for health systems, today announced a strategic investment from Morningside Ventures, a leading investor in healthcare innovation.
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Cyted Health Expands US Presence with First Patients Enrolled in DETECT-ME Clinical Validation Study
Cyted Health, a leading gastrointestinal molecular diagnostics company, today announces the enrollment of the first patient in the DETECT-ME clinical validation study (NCT06803927).
Nanowear Announces Continuous Glucose Monitoring (CGM) Licensing and Data Partnership With Dexcom
Nanowear, a leader in home-based cardiometabolic digital diagnostics announced that SimpleSense™, a nanotechnology-enabled wearable, mobile and software diagnostics platform, will ingest glucose data from Dexcom G7 Continuous Glucose Monitoring Systems (CGM) time synchronously alongside Nanowear’s previously FDA cleared cardiovascular biomarkers.
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Diagnosing diseases and saving lives with AI featuring IMVARIA
Dr. Joshua Reicher, co-founder and CEO of IMVARIA, initially missed the opportunity to develop a company similar to DraftKings and instead decided to focus on saving lives.
AtaCor Medical Enrolls First Patients in its ASCEND EV Clinical Study
AtaCor Medical, Inc., a privately-held medical device company focused on transforming cardiac rhythm management, announced today that it has initiated its ASCEND EV study.
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Kevin Kearney Joins Lungpacer Medical as Chief Commercial Officer
Company Appoints Medical Device and Healthcare Industry Veteran with 20 Years of Experience
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Accuryn Medical Announces Leadership Transition With Appointment of Todd Dunn as CEO
Accuryn Medical, a company dedicated to addressing acute kidney injury through real-time renal monitoring and assessment based on global clinical practice guidelines, today announced that Todd Dunn, Accuryn’s Chief Transformation Officer, will transition to a new role leading the company as Chief Executive Officer.
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Sibel Health Announces Close of New Series C Financing and New FDA 510(k) Clearance
Sibel Health, an award-winning medical technology company, is pleased to announce the closing of $30 million in new equity financing and its 7th FDA 510(k) clearance.
Stanford Medicine and LEADOPTIK Announce Research Collaboration to Advance AI-Enhanced, Real-Time Optical Imaging in Lung Cancer Biopsy
LEADOPTIK Inc., a Silicon Valley-based medical imaging company today announced that it has entered into a research collaboration with Stanford Medicine to explore the use of AI-enhanced real-time optical imaging in lung biopsy procedures.
Moon Surgical gets FDA nod for AI-enhancement for surgical robot
Moon Surgical announced today that it received FDA clearance for ScoPilot, a Nvidia-enabled platform for its Maestro surgical robot. The Paris-based company also announced further integrations with Nvidia technologies, including the Isaac for Healthcare platform.
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FDA Grants 510(k) Clearance for Perfusion Pressure on the MY01’s Mobile Application
MY01, an innovative medical technology company dedicated to transforming the diagnosis of limb perfusion injuries, is excited to announce that the inclusion of Perfusion Pressure, a key physiological indicator for complications like compartment syndrome or acute limb ischemia, on the MY01 Mobile Application, has received 510(k) marketing authorization from the FDA, along with Breakthrough Designation.
Subtle Medical Advances GenAI Innovation in Radiology with NVIDIA
Medical imaging today faces several critical challenges. Imaging modalities like MRI, PET, and CT are used in over five hundred million patients annually for diagnosis and treatment, involving long scan times and/or potentially high radiation and contrast dosage.
Moon Surgical receives FDA clearance for ScoPilot™ on Maestro, industry’s first AI-enhanced intraoperative capability, powered by NVIDIA Holoscan
Moon Surgical, a French-American pioneer in surgical innovation, announced today the United States Food and Drug Administration (FDA) clearance for ScoPilot.
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Why these 10 medical device makers are the most innovative in the world featuring Bruin Biometrics
Bruin BiometricsFor helping detect bedsores in patients regardless of skin color
Subtle Medical’s SubtleHD™ Receives CE Mark, Expanding Access to AI-Powered MRI Enhancement Across Europe
Subtle Medical, a global leader in AI-powered medical imaging enhancement, announced today that SubtleHD™ has received CE Mark certification, officially launching the solution in Europe. The software is designed to dramatically improve MRI image quality, reduce scan times by up to 80%, and optimize radiology workflows.
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Wellinks and CareAbout Health Partner to Expand Value-Based COPD Management in New Jersey and Florida
Wellinks, a digital healthcare company specializing in Chronic Obstructive Pulmonary Disease (COPD) management, today announced a strategic partnership with CareAbout Health, a leading healthcare management company.
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Cancer: Biotech NovaGray rolls out its radiotherapy tolerance test
Radiotherapy relies on the use of a variety of rays that target and damage tumors, gradually destroying them. It is particularly favored in the treatment of the nearly 3.5 million people suffering from prostate or breast cancer in Europe and the United States, according to a study conducted by Rothschild for the Montpellier-based biotech company NovaGray.
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RevBio Initiates its Pivotal Clinical Trial in Europe for its Dental Implant Stabilization Product
RevBio, Inc., announced that it has received regulatory and ethics committee approvals in multiple European countries to conduct its pivotal clinical trial for its dental implant stabilization product.
Maria Artunduaga, Founder and CEO of Samay selected for Inc. Magazine’s 2025 Female Founders list
For developing a non-invasive lung function monitoring device to support people with respiratory conditions, conducting extensive clinical trials, and securing the largest funding round for a Latina-led medtech company in the U.S.
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Spineart and eCential Robotics announce FDA clearance of PERLA® App for use with Op.nTM robotic navigation platform
Spineart, a fast-growing company in spine surgery innovation, and eCential Robotics, an expert company in surgical robotics, proudly announce the 510(k) clearance from the U.S.
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Implantable Bioelectronic Device to Reverse Degenerative Disc Disease featuring Discure Technologies
The Discure System from Discure Technologies Ltd. is changing the way mid-stage degenerative disc disease (DDD) is treated. The device is a bioelectronic technology implanted via injection into a disc during an outpatient, minimally invasive procedure intended to reverse early DDD.
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MicroTransponder Secures $65 Million to Enhance Vivistim Adoption for Chronic Stroke Recovery
Announcing a $65 million Series F financing round, MicroTransponder®, Inc., one of the fastest-growing stroke companies, is transforming the stroke continuum of care with its FDA-approved Vivistim® Paired VNS™ System.
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Growing Market Applications, Centerline Biomedical Granted FDA 510(k) Clearance for IOPS® with New, Expanded Indication for Use
Centerline Biomedical, Inc. (“Centerline”), an innovative leader in cardiovascular navigation and visualization systems, announced that the company has received US Food and Drug Administration (FDA) 510(k) clearance of expanded indications for its Intra-Operative Positioning System (IOPS).
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Translation of Laparoscopic Surgical Innovation: Discovering and Deciphering Practices and Policy Impacts featuring ClearCam
Christopher R. Idelson, ClearCam; Maansi Srinivasan, ClearCam; Austin Fagerberg, McGovern Medical School, The University of Texas, ClearCam; John M. Uecker, Dell Medical School, The University of Texas at Austin and ClearCam; Douglas G.
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May Health Appoints Seasoned Medtech Executive, Colby Holtshouse, as President and CEO
May Health, a Paris- and California-based, clinical-stage medical device company dedicated to the development of a new treatment for Polycystic Ovary Syndrome (PCOS), today announced that Colby Holtshouse has joined the Company as President and CEO.
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Lungpacer wins FDA IDE for AeroNova system
Lungpacer Medical announced today that it received FDA investigational device exemption (IDE) to begin a trial for its AeroNova system. The STARI (stimulation to activate respiration) trial evaluates the feasibility of the investigational AeroNova system.
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CLEW Announces the Launch of its Sepsis Virtual Unit to Enhance SEP-1 Compliance and Improve Patient Outcomes
CLEW, a leading provider of AI-driven clinical surveillance solutions, today announced the launch of its Sepsis Virtual Unit (SVU), designed to help healthcare organizations improve sepsis detection, enhance SEP-1 compliance, and drive better patient outcomes.
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10 Dental Technologies That Inspire for 2025 featuring iDentical
iDentical is changing the paradigm of implant dentistry with the first drill-free, patient-specific, 3D-printed dental implants. By leveraging 3D scanning and CAD/CAM technology, a patient-specific, one-piece dental implant can be modeled from the patient’s own tooth root and then 3D-printed in titanium with unique design features.
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Let’s Talk About Women’s Health – ReConstruct
When promoting the ReConstruct technology, which improve the lives of patients undergoing breast reconstruction, our social media team found that the use of the world “breast”
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NovaGray partners with Eurofins Biomnis to tailor cancer treatments to each patient
Nearly 30 years of work have come to fruition. ” We founded NovaGray in 2015 with Professor David Azria, an oncologist. When we met in 2015, he had been working for nearly 20 years on developing tests to assess patients’ tolerance to radiotherapy ,” says Clemence Franc, CEO of NovaGray.
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Accuryn Medical Achieves Sales Milestone of 100,000 Catheters Shipped Nationwide
Accuryn Medical, a company dedicated to addressing acute kidney injury (AKI), through real-time renal monitoring and assessment based on global clinical practice guidelines, today announced that they have shipped 100,000 SmartFoley catheters across the United States.
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Backgrounder: PacifiCan announces $18.3 million to scale up local businesses, boost B.C. exports, and opens new intake for business growth program featuring HealthTech Connex
Funding will enable HealthTech Connex, a life sciences company based in Surrey, to expand its operations. The company’s advanced brain imaging medical device, NeuroCatch® Platform, evaluates cognitive function within six minutes at the point-of-care.
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Discure Technologies Accepted into FDA TAP Program for Its Breakthrough Device for Degenerative Disc Disease
Discure Technologies, a clinical-stage medical device company pioneering treatments for degenerative disc disease and other orthopedic disorders, today announced its acceptance into the U.S.
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Israeli biomedical firm Nurami bags $30m
Israel-based biomedical company Nurami Medical has raised US$30 million in its latest funding round. The funds will help expand its workforce and scale operations, including the construction of a commercial manufacturing facility, research and development lab, and clean rooms for producing its first FDA-approved product.
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Boston Scientific announces agreement to acquire SoniVie Ltd.
Boston Scientific Corporation (NYSE: BSX) today announced it has entered into a definitive agreement to acquire SoniVie Ltd., a privately held medical device company that has developed the TIVUS™ Intravascular Ultrasound System.
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CytoChip receives FDA clearance and first CLIA Waiver for CitoCBC
CytoChip announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and a CLIA Waiver for its CitoCBC, making it the first cartridge-based CBC test to achieve this milestone.
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Neurovalens Expands Access to Modius Sleep for Veterans Through U.S. Department of Veterans Affairs (VA) Program
Neurovalens, a global leader in noninvasive neurostimulation technology, is making significant strides in addressing chronic insomnia among U.S. veterans.
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Bright Uro Announces Chief Medical Officer and Commercial Team
Bright Uro, a medical device company with a mission to transform care for lower urinary tract symptoms (LUTS) through innovations in urodynamics, today announced the appointment of its new Chief Medical Officer, Dr.
How Samay’s CEO came up with the `sound’ idea for a device to battle COPD, win MedTech Innovator
In this episode of the DeviceTalks Weekly Podcast, Host Tom Salemi talks with Dr. Maria Artunduaga, the founder and CEO of Samay, a startup that’s using acoustic energy to get a clearer picture of the lung’s performance.
FDA Clears OXOS Medical’s MC2 X-Ray System
OXOS Medical has gained U.S. Food and Drug Administration clearance for its MC2 Portable X-ray System.
Subtle Medical’s SubtleHD™ Awarded FDA Clearance, Setting a New Benchmark for MRI Image Quality and Speed
Subtle Medical, the global leader in AI-powered medical imaging enhancement, announced today the FDA clearance for Subtle-HD™, the industry’s most advanced MRI acceleration and enhancement software to date.
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Otolith Labs Announces Data Demonstrating Otolith Technology Effectiveness on Cybersickness from Virtual Reality in Exploratory Study
Original research article published by Frontiers, a top peer-reviewed scientific journal
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Steve Pacelli Appointed CEO of Epitel, Inc.
Epitel, Inc., a leader in AI technologies for patient-focused brain health solutions, is pleased to announce that Steve Pacelli has been appointed as the company’s new Chief Executive Officer.
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Cylinder Recognized Nationally for Digestive Health Innovation
Cylinder, the employee benefit provider for digestive health, is proud to announce it has been recognized by two major honors. Cylinder has been named to the 2025 New York Digital Health 100 (DH100), an annual list recognizing the most innovative and impactful companies in digital health.
Access Vascular Catheters with MIMIX® Technology Added to Recon Supply’s Federal Supply Schedule Contract
Access Vascular, Inc. (AVI), a leader in tackling critical vascular access challenges with its advanced hydrophilic biomaterial technology, today announced that its portfolio of vascular access catheters made with MIMIX® technology has been added to Recon Supply’s Federal Supply Schedule (FSS) contract, as well as their Distribution and Pricing Agreement (DAPA) with the Defense Logistics Agency (DLA).
HydroMID Midline Catheter from Access Vascular Receives FDA Clearance
Feb. 11, 2021- Access Vascular, Inc. today announced FDA clearance of its HydroMIDTM midline catheter. HydroMID, which is made of Access Vascular’s proprietary biomaterial that has been shown to reduce thrombus accumulation by up to 97 percent when compared to standard polyurethane catheters,1 is the second device in its planned portfolio to obtain clearance.
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Retia signs US distribution Agreement for Argos® Cardiac Output Monitor with Medtronic
Retia Medical, an innovator in AI algorithms for patient monitoring and management, announced that it has entered into an agreement with Medtronic plc, a global leader in healthcare technology, to distribute the Argos Cardiac Output Monitor designed to provide healthcare professionals with highly accurate hemodynamic data to support the treatment of high-risk surgical and critically ill patients.
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Concord Health Partners Portfolio Companies NeuroFlow and Iris TeleHealth Complete Acquisitions to Enhance Leading Behavioral Health Capabilities
Concord Health Partners (“Concord”), a healthcare focused investment firm, today announced recent transactions by two of its behavioral health portfolio companies.
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Sibel Announces its 4th FDA Clearance for Continuous Wearable Vital Signs Monitoring with ANNE® One and Additional Strategic Collaboration with Ann & Robert H. Lurie Children’s Hospital of Chicago
Sibel Health, a leading digital health company, announced today that its continuous wearable monitoring solution, ANNE® One, has received another 510(k) clearance from the U.S.
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MicroTransponder Vivistim nerve stim tech delivers positive stroke outcomes
MicroTransponder recently announced positive real-world outcomes for its Vivistim vagus nerve stimulation (VNS) system. Data highlighted Vivistim’s impact when paired with occupational or physical therapy to help ischemic stroke survivors improve hand and arm function.
European Brain Surgery Start-Up Seeks US Expansion featuring Robeauté
Robeauté, a start-up which promises to transform brain surgeries with microrobots the size of a grain of rice, has raised $28 million in its latest funding round.
Arsenal Medical Announces Complete Enrollment of the Initial Cohort in the EMBO-02 Study Assessing NeoCast™ for the Treatment of Chronic Subdural Hematoma
Arsenal Medical, a clinical-stage company developing medical devices from innovative biomaterials, today announced the complete enrollment of an initial cohort of 10 patients in the EMBO-02 clinical study of NeoCast™ to treat chronic subdural hematomas (cSDH) across three sites in Australia.
Medtech Pioneers: Lisa Carmel sits down with Maria Artunduaga, founder and CEO of Samay
In Medtech Pioneers episode 8, Lisa Carmel sits down with Maria Artunduaga, MD, MPH, MTM, founder and CEO of Samay — The Winner of the 2024 MedTech Innovator Grand Prize focused on building hardware, software, and a data analytics platform to do pulmonary function remotely, not invasively, and affordable for patients who have respiratory disease.
AccurKardia Earns FDA Breakthrough Device Designation for AK+ Guard™
AccurKardia, a pioneer in ECG-based diagnostics technology, has announced a major milestone: the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its AK+ Guard™ hyperkalemia detection software.
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A Promise to My Mother: Building a Better Future for Chronic Care featuring Aidar Health
Today marks one year since my mother, Viji, passed away. She was the inspiration behind Aidar Health, the driving force behind everything I’ve worked for, and a shining example of resilience, love, and determination.
Samay Puts an Ear to the Ground on Respiratory Disease
Samay recently made history by becoming the first Latin American company to win the Grand Prize at Medtech Innovator’s 2024 conference, which awarded the start-up $350,000 in nondilutive cash and cast a venerated spotlight on its impactful work in the COPD space.
Inflammatix Receives FDA Clearance for First-in-Class TriVerity™ Test
TriVerity expected to enable timely and confident decision-making for emergency departments
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TEDCO Invests in NanoBioFAB
TEDCO, Maryland’s economic engine for technology companies, announced a $200,000 Pre-Seed Builder Fund investment in NanoBioFAB. The Pre-Seed Builder Fund invests in and provides executive support to Maryland-based technology companies run by entrepreneurs who demonstrate economic disadvantage.
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NeuroBionics Secures an Oversubscribed $5M Seed Round to Advance Endovascular Neuromodulation Technology
NeuroBionics, a neurotech company revolutionizing neuromodulation therapy with minimally invasive implantable devices, today announced the successful close of its $5 million Seed Round.
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GT Medical Technologies Raises $37 Million in Series D to Advance the Expansion of GammaTile® in the U.S. for Patients with Operable Brain Tumors
GT Medical Technologies, Inc. (GT MedTech), a medical device company with a corporate purpose of improving the lives of patients with brain tumors, today announced the company has completed a $37 million first close of a Series D financing round.
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Plexāā Partners with Panasonic Manufacturing UK for BLOOM⁴³ Medical Device Production
Plexāā, a London-based medical device startup, has joined forces with Panasonic Manufacturing UK to scale the production of its award-winning BLOOM⁴³ medical device.
This MIT spinout wants to spool hair-thin fibers into patients’ brains featuring NeuroBionics
You can’t start a company without a healthy dose of daring, and that’s certainly the case with NeuroBionics. The MIT-spinout thinks it could one day improve the lives of millions of people who live with neurological conditions like depression, epilepsy, and Parkinson’s disease.
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Novus Diagnostics Secures €4.6M in Equity Financing to Revolutionize Rapid Point-of-Care Diagnostics
Novus Diagnostics Secures €4.6M in Equity Financing to Revolutionize Rapid Point-of-Care Diagnostics. Novus Diagnostics, a pioneering medical technology company, proudly announces the successful closing of a €4.6M equity financing round.
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Alleviant Medical Secures $90 Million Financing to Expand Interventional Heart Failure Pivotal Trial Program
Alleviant Medical, Inc., a privately held medical device company developing a no-implant atrial shunt for heart failure, today announced a $90 million financing to fund its second pivotal trial.
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IMVARIA Receives 510(k) Clearance for ScreenDx, a First-of-its-Kind Screening Algorithm to Assess for Interstitial Lung Disease
Berkeley, Calif. – January 13, 2025 − IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced its second FDA authorization, securing 510(k) clearance from the U.S.
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Synergia Medical Announces: Five Patients Now Implanted with Nao.Vns™ Leadership Change: Charles Nolet To Succeed Attila Borbath As CEO
Brussels, January 13, 2025. Synergia Medical SA, a leader in developing optoelectronic medical devices, is pleased to announce the successful implantation of its groundbreaking NAO.VNSTM system in three more patients, bringing the total to five, as part of the AURORA study.
Development and Internal Validation of an AI-Enabled Cuff-less, Non-invasive Continuous Blood Pressure Monitor Across All Classes of Hypertension featuring Nanowear
Background: Non-invasive, continuous blood pressure monitoring technologies require additional validation beyond standard cuff-based methods. This study evaluates a non-invasive, multiparametric wearable cuffless blood pressure (BP) diagnostic monitor across all hypertension classes with diverse subjects.
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Exclusive: Startup pioneering tiny robots that can travel inside the brain gets $28 million in new venture funding featuring Robeauté
The 1966 science fiction film Fantastic Voyage imagined a technology that could shrink people to microscopic size so they could use a tiny submarine to travel through a person’s body and repair a blood clot in an injured scientist’s brain.
Universal Brain Announces Publication of Groundbreaking Depression Research Using Multiple Event-Related Potentials
Universal Brain, a pioneering technology company focused on transforming mental healthcare through neuroscience, today announced the publication of its latest peer-reviewed study, “Neurotyping depression using multiple event-related potentials (ERPs): Leveraging task-based variation to predict remission in depression,”
Horizon Technology Finance Provides $35 Million Venture Loan Facility to Onkos Surgical® to Accelerate Commercialization of Novel Antibacterial Implant Technology
Horizon Technology Finance Corporation (NASDAQ: HRZN) (“Horizon” or the “Company”), an affiliate of Monroe Capital, and a leading specialty finance company that provides capital in the form of secured loans to venture capital-backed companies in the technology, life science, healthcare information and services, and sustainability industries, today announced it has provided a $35 million venture loan facility to Onkos Surgical (“Onkos”), of which $30 million has been initially funded.
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AI-powered smart mirrors, snore-blocking earbuds and waterproof TV turn heads at CES 2025 featuring Ozlo Sleepbuds
In the wearables category, startup Ozlo displayed its “Sleepbuds” – a pair of Bluetooth-enabled earbuds developed by former Bose engineers that help users fall asleep faster by masking outside noises like snoring or police sirens.
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InkSpace Imaging Receives FDA 510(k) Clearance for 1.5T 24-channel MR Coil for Siemens Healthineers
InkSpace Imaging, a leader in MRI coil innovation, today announced that the United States (US) Food and Drug Administration (FDA) has cleared InkSpace Imaging’s next-generation 1.5 Tesla (1.5T) 24-channel MR coil for Siemens Healthineers Magnetom MRI scanners.
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Relief Cardiovascular Announces $12M Series A Financing to Advance First-in-Human Study of the Relief System
Relief Cardiovascular, an inQB8 Medical Technologies portfolio company pioneering innovative solutions for the management of heart failure, today announced the closing of a $12M Series A financing.
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Zeto, Inc., Secures $31 Million In Series B Funding To Redefine The Future Of EEG Brain Monitoring
Zeto, Inc., a fast-growing medical technology company revolutionizing EEG diagnostics with its cutting-edge devices and AI-driven cloud platform, has announced the recent successful closing of a $31 million funding round.
Revolutionizing Kidney Care: AccurKardia’s AK+ Guard Earns FDA Breakthrough Device Designation
AccurKardia has received breakthrough device designation by FDA for its ECG-based, AI-powered AK+ Guard hyperkalemia detection software. The investigational technology uses lead I ECG data to alert patients and clinicians of moderate to severe episodes of hyperkalemia (excess potassium in the blood) that can lead to sudden cardiac arrest.
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AirStrip® Technologies Adds Clinical Decision Support Capabilities with Strategic Acquisition of DECISIO® Health
AirStrip®, a leader in advanced clinical monitoring and alarm management solutions, has announced the acquisition of DECISIO® Health, a provider of innovative clinical decision support and visualization tools.
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A New Chapter for Prana Thoracic
At Prana Thoracic, we’ve always been dedicated to innovation that transforms lives, starting with our advancements in precision surgery for lung cancer. Today, we’re excited to share a pivotal step in our journey: Prana Thoracic is becoming Prana Surgical.
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From Big Tech to Biomarkers: Reflections of an Accidental Health Tech Entrepreneur
As 2024 comes to a close, I’ve been reflecting on the incredible path I’ve traveled since founding Blumio eight years ago. Leaving big tech to start a wearable blood pressure company was a leap into the unknown—a decision driven by a belief in the power of technology to transform health outcomes.
Jeffery Alvarez & Joe Mullings: Moon Surgical Update December 2024
Moon Surgical sits down with Joe Mullings for an update on Moon Surgical.
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Continuous Biomarker Monitoring Pioneer Proton Intelligence Inc Announces a $6.95 Million Seed Raise to Initiate Human Trials for Potassium Monitoring in Patients With Kidney Disease
Proton Intelligence Inc., developing the first-ever Continuous Potassium Monitoring (CKM™) platform, today announced the closing of its $6.95 million USD Seed Financing round joined by SOSV, We Venture Capital, Tenmile, LongeVC, 15th Rock, Exor, and Trampoline Venture Partners.
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Nitinotes announces closing $9.3M SAFE round
Nitinotes has successfully closed a $9.3M SAFE round led by MTIP, with participation from Techwald Holdings and Elron. This funding supports preparations for commercialization, regulatory approval, and scaling of the EndoZip™ system.
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Fixing Healthcare Bottlenecks from First Principles: Interview with Enspectra Health CEO Gabriel Sanchez
Gabriel Sanchez, co-founder and CEO of Enspectra Health, earned his bachelor’s degree from MIT and his master’s and PhD in mechanical engineering from Stanford.
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Fluid Biomed Inc. Raises $27 Million USD in Oversubscribed Series A Financing to Advance World’s First Bioabsorbable Polymer-Based Stent To Treat Brain Aneurysms
Fluid Biomed Inc., a clinical stage medical device company developing lifesaving products for patients suffering from vascular disease, closed an oversubscribed $27 million USD Series A equity financing.
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First Look: Flow Medical’s next-generation thrombolysis catheter for pulmonary embolism
Flow Medical is developing a thrombolysis catheter to improve the treatment of blood clots in pulmonary embolism patients. The Chicago-based startup designed its minimally invasive system with a novel nitinol scaffold that perforates blood clots and infuses them with tissue plasminogen activator (TPA), a thrombolytic drug commonly referred to as a clot-buster.
Execution Beats Flashy Funding: Interview with AccurKardia CEO Juan C. Jimenez
Juan C. Jimenez began his career in finance and investment banking, specializing in M&A transactions at Credit Suisse. After the 2008-2009 financial crisis, he pivoted to real estate distressed credit investment, which led him to a surprising role as President of a non-emergency medical transportation company.
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Liquet™ Medical Inc. Receives FDA 510(k) Clearance for the Versus™ Catheter: Hemodynamics-Led Thrombolysis (HLT) allows Physicians to Personalize the Treatment of Blood Clots in the Lungs utilizing Real-Time Pulmonary Artery Pressure.
Liquet Medical Inc., a pioneering medical device company committed to advancing patient care through innovative technologies, today announced it has received 510(k) clearance from the U.S.
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Zetagen Therapeutics Shares In-vivo Dose Optimization Data of ZetaMAST™ (Zeta-MBC-005) Metastatic Breast Cancer in Liver
Central New York Biotech Accelerator (CNYBAC) — Zetagen Therapeutics, Inc., a private, clinical stage, biopharmaceutical company focused on developing proprietary carriers delivering tumoricidal therapies for metastatic and primary breast cancer, minimizing patient side effects with the potential to increase survival rates, announced today in-vivo results of their dose optimization study of ZetaMAST™ (Zeta-MBC-005).
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New Investment from FBomb Angels featuring Opticyte
Thank you to the FBomb Angels for a meaningful investment that supports our mission to transform health equity and sepsis detection through our VitalO₂ monitor.
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Demonstrating commitment to continuous portfolio innovation, Centerline Biomedical receives FDA 510(k) clearance for new IOPS® Guidewire Handle and launches its latest software advancements
Centerline Biomedical, Inc. (“Centerline”), an innovative leader in cardiovascular navigation and visualization systems, announced that the company has received US Food and Drug Administration (FDA) 510(k) clearance for its new IOPS Guidewire Handle.
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PhotoniCare Announces a First Close of $4.6 Million in Series B Financing, a Manufacturing Partnership with Gentex Corporation, and Relocation of its Headquarters to Grand Rapids, Michigan
PhotoniCare Inc., a medical device company dedicated to delivering innovation to frontline care that demonstrably enhances patient outcomes, is pleased to announce that it has secured $4.6 million in Series B financing, formed a manufacturing partnership with Gentex Corporation for its first-in-class, FDA-cleared OtoSight™ Middle Ear Scope, and finalized the relocation of its headquarters from Champaign, Illinois to Grand Rapids, Michigan.
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The best sleep earbuds you can buy just got a Cyber Monday discount
The Ozlo Sleepbuds are the most comfortable sleep earbuds I’ve tested, and they’re $30 off during Cyber Monday. But jump on this deal while it’s still live.
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Forbes 30 Under 30 featuring StrokeDx
There are two different primary types of strokes. Diagnosing the correct one is crucial-but can take hours. Ballatori’s and Shahrestani’s company, StrokeDx has developed portable imaging devices that determine stroke type in minutes.
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Cancer Fund Impact Investments
CANCER FUND is pleased to announce its investment in NXgenPort, an early-stage company developing technology to advance remote monitoring of cancer patients’ health. This marks Cancer Fund I’s seventh investment and reflects its dedication to fostering impactful innovations in oncology.
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InkSpace Imaging Submits FDA 510(k) for 1.5T 24-channel Body Array for Siemens Healthineers MRI Scanners
InkSpace Imaging, a leader in MRI coil innovation, has announced the submission for FDA clearance of its next-generation body array for Siemens Healthineers Magnetom 1.5 Tesla MRI scanners.
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Gravitas Medical, Inc. Announces SECOND FDA Clearance for its Entarik System; Neonatal Patients to Benefit from Enteral Nutrition Innovation
Gravitas Medical, Inc. is pleased to announce that it received Neonatal 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance allows Gravitas Medical to market its revolutionary Entarik technology to the US neonatal population.
Acorai closes $4.5M investment from the European Innovation Council (EIC) Fund
Acorai, a Swedish developer and manufacturer of innovative devices for heart failure management, announced the closing of a $4.5M investment from the EIC Fund, Taiwan Medical University, and private investors.
Mentorship Program Sparks U.S.-Latin American Doctor’s Shift to Medtech featuring Samay
Maria Artunduaga’s grandmother never smoked. However, like many members of her generation, she was exposed to second-hand cigarette smoke much of her life.
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Zenflow Announces $24 Million Financing Round to Fund FDA Filing & Commercial Preparation
Zenflow, Inc., a medical device company developing a minimally invasive treatment for urinary obstruction caused by enlarged prostate, or benign prostatic hyperplasia (BPH), today announced that it has closed a $24 million Series C financing round.
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Healionics’ STARgraft Receives FDA Breakthrough Device Designation
Healionics Corporation, a developer of synthetic biomaterial-based medical devices, today announced that its STARgraft arteriovenous graft – designed to provide a safer and more reliable means of bloodstream access for kidney failure patients needing dialysis – has been granted Breakthrough Device designation by the FDA.
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myBiometry raises funding to advance development of fenoTRACK device
MyBiometry has secured a $5m investment in an oversubscribed seed funding round to propel the development of its fenoTRACK device for asthma and chronic obstructive pulmonary disease (COPD).
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Zetagen Therapeutics Announces First Patients Enrolled in Phase 2a Clinical Study of ZetaMet™ (Zeta-BC-003) Metastatic Breast Cancer
Central New York Biotech Accelerator (CNYBAC) — Zetagen Therapeutics, Inc., a private, clinical stage, biopharmaceutical company focused on developing breakthrough therapies, via local administration, for metastatic breast cancer to bone and soft tissues, announced today that the first two patients have enrolled in the phase 2a study, which will evaluate ZetaMet™ (Zeta-BC-003) in the treatment of spinal metastatic lytic breast cancer lesions (ClinicalTrials.gov #NCT05280067).
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Histology in your hands: cross-modal imaging shows living skin in full color featuring Enspectra Health
A long-sought goal in dermatology has been the development of an imaging modality with sufficient resolution and compositional detail to noninvasively interrogate skin histology in vivo.
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Plio Surgical wins big at the InterTradeIreland start-up competition
Medical device developer Plio Surgical was announced as the overall winner at an all-island investor readiness competition, taking home €100,000. The annual InterTradeIreland all-island Seedcorn Investor Readiness Competition aims to improve the investor readiness of new-start and early-stage businesses across the island.
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MedTech Innovator at 10 featuring ExplORer Surgical, BardyDx, and Pathology Watch
Over the 10 years since Paul Grand created the medtech industry’s largest accelerator, it has helped start-ups launch many innovative medical products. We speak with the founders of ExplORer Surgical, BardyDx, and Pathology Watch about the role MedTech Innovator played in their successful exits.
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Bright Uro Announces Oversubscribed $32M Series A Funding Round
Bright Uro, a medical device company with a mission to transform care for lower urinary tract symptoms (LUTS) through innovations in urodynamics, today announced the second closing of its Series A funding round, which was oversubscribed by nearly 40% above and secured a total of $32M for the company.
Telix Partners with Subtle Medical on AI-Enabled SubtlePET™ Software for Faster PET Imaging with Illuccix®
Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces a partnership with California-based Subtle Medical, Inc. (Subtle Medical) for artificial intelligence (AI)-powered positron emission tomography (PET) imaging with Telix’s commercial PSMA-PET1 product, Illuccix® (68Ga-PSMA-11).
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2024 Startup Battlefield Top 20 Finalists: MDC | TechCrunch Disrupt 2024
MDC is revolutionizing surgery with a novel robotic system that provides physicians direct access inside MRI scanners.
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InBrain Neuroelectronics raises $50M Series B to support BCI
InBrain Neuroelectronics announced today that it closed a Series B financing round with proceeds totaling $50 million. The Barcelona, Spain-based company also secured additional funding and support from Merck KGaA.
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Trinity Biotech Announces Strategic Investment in Novus Diagnostics to Advance Rapid Sepsis Testing Platform
Trinity Biotech plc (TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced a strategic investment in Novus Diagnostics, a company pioneering a rapid sepsis testing platform.
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Deephealth Expands Its AI-Powered Cancer Diagnostic and Screening Portfolio with the Acquisition of Kheiron
DeepHealth has acquired Kheiron Medical Technologies Limited, a UK-based AI cancer diagnostic company focused on developing deep learning solutions to support radiologists improve breast cancer detection.
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Loop Earplugs, UBlockout, and Neurovalens Win National Sleep Foundation’s 2024 SleepTech® Award
The National Sleep Foundation (NSF) named Loop Earplugs, UBlockout, and Neurovalens as winners of the 2024 SleepTech® Award. NSF’s SleepTech Award recognizes the year’s most innovative efforts in advancing sleep technology and is a feature of NSF’s ongoing work to encourage and celebrate efforts when sleep science and insight are rapidly incorporated into accessible health products and services.
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Release: NIH announces winners of prize competition to improve postpartum maternal health and health equity through innovative diagnostics featuring CardieX, Caretaker Medical, Sibel Health, and PyrAmes
The National Institutes of Health (NIH) has announced the winners of the Rapid Acceleration of Diagnostics Technology (RADx® Tech) for Maternal Health Challenge, an $8 million prize competition to encourage development of postpartum maternal health diagnostics for use in regions that have limited access to maternity care.
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VitalStream Offers Continuous Hemodynamic Monitoring Solution Amid IV Fluid Shortage
VitalStream can help hospitals reduce their reliance on IV fluids for blood pressure measurement and can be used to decide which patients benefit from fluid.
AccurKardia Receives FDA Breakthrough Device Designation for First-of-its-Kind Aortic Valve Stenosis ECG-based AI Screening Software
AccurKardia, an innovator in ECG-based diagnostics technology, has announced that its Aortic Valve Stenosis (AVS) ECG-based AI screening software has been granted Breakthrough Device Designation by the U.S.
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Emma Watson invests in reproductive health company Hertility
Actress Emma Watson has made a previously undisclosed investment into the women’s health company Hertility, bringing its total funding to more than $14 million, the company told TechCrunch in an interview on Monday.
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New Haven-based digital healthcare firm Wellinks acquires San Francisco tech company
Wellinks Inc., a New Haven-based digital healthcare firm, said Monday it has acquired San Francisco-based medical device and data company Spire Health in a non-cash transaction.
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Open Mind Health Announces Strategic Partnership with NeuroFlow to Enhance Mental Health and Wellness Services
Open Mind Health, a leading provider of innovative mental telehealth and holistic wellness solutions, and NeuroFlow, a renowned leader in behavioral health technology infrastructure, are partnering to strengthen Open Mind Health’s delivery of measurement-based care.
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Meta developed a ‘neural interface’ for its next-gen Orion AR glasses
At the Meta Connect 2024 conference, CEO Mark Zuckerberg said that the company is developing a “neural interface” that can be used to control its prototypical Orion AR glasses.
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NIH Awards Sonavex $2 Million Grant to Conduct Clinical Trial and Seek Regulatory Clearance of EchoGuide
Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced today that it was awarded a $2 million Small Business Innovation Research (SBIR) Phase IIB Grant from the National Institutes of Health (NIH) to advance EchoGuide, Sonavex’s pipeline product designed to reduce cannulation injury for dialysis patients.
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Raydiant Oximetry Secures $1 Million Grant to Advance Fetal Monitoring Technology
Raydiant Oximetry, Inc., a clinical-stage medical device company developing innovations to keep mothers and babies safe during childbirth, has announced the receipt of a $1 million grant from the Bill & Melinda Gates Foundation.
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Caretaker Partners with Red One Medical to Expand Advanced Monitoring to More Veterans and Hospital Departments
VitalStream offers veterans uninterrupted hemodynamic and vital signs monitoring to aid in the early detection of decline and precise treatment.
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Amir Soltanianzadeh, CardiaCare / Solardis Health Ventures – Studio Interview | LSI Europe ’24
CardiaCare is a clinical stage Digital Therapeutic company that develops the world’s first closed loop wearable for non-invasive treatment of cardiac and other Central Nervous System related clinical symptoms.
EDAP and Avenda Health Launch World’s First AI-Assisted Focal One Robotic HIFU
EDAP TMS SA, the global leader in robotic energy-based therapies, and Avenda Health, a leading AI healthcare company, announced a collaboration agreement to offer personalized prostate cancer care, utilizing Avenda’s Unfold AI technology to launch the world’s first AI-assisted Focal One robotic high-intensity focused ultrasound (HIFU) procedures.
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FDA clears EEG for brain analysis from Forest Devices
Forest Devices announced today that it received FDA 510(k) clearance for its SignalNED Model RE system for brain state analysis. This marks the first FDA clearance for the company, which won MedTech Innovator’s 2019 accelerator competition.
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Sparta Biomedical Reports Treatment of First Patients with Breakthrough Device, Ormi
Sparta Biomedical, a private medical device company focused on osteoarthritis repair solutions, today announced that it has successfully implanted its Ormi device in patients with focal knee lesions as part of its first-in-human clinical trial.
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Remedee Labs’ Solution becomes the first CE marked medical device (class IIa) approved for the treatment of fibromyalgia in Europe
Remedee Labs, a French start-up that specializes in non-pharmacological treatments for chronic pain, is announcing today that it has obtained medical device status in Europe for its millimeter wave endorphin stimulator wristband.
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X-Bolt Receives Prestigious ‘Best Technology in Spine’ Award from Orthopedics This Week
X-Bolt Orthopedics, an emerging innovator of bone fixation implants in orthopedics, has been awarded the Best Technology In Spine Award for 2024/2025 by Orthopedics This Week.
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Darmiyan, Inc. Announces Launch of Groundbreaking BrainSee Platform for Alzheimer’s Testing
Darmiyan, Inc., a pioneer in brain technology, is proud to announce the launch of the BrainSee Platform, integrating the first-of-its-kind FDA-approved BrainSee Test for Alzheimer’s disease.
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DASI Simulations earns FDA clearance for second AI-powered imaging product; continues to build structural heart platform
DASI Simulations announced today that its second product – DASI Dimensions – has earned FDA clearance. “Our mission – to provide an artificial intelligence (AI)-powered structural heart platform that allows physicians to be more efficient and use their expertise more effectively – is moving forward with great momentum,”
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EXCLUSIVE: Bloomlife Secures $12.2M Series A to Advance Remote Maternal Care Platform
Bloomlife, a leader in maternal health technology, has successfully raised $12.2 million in a Series A funding round, marking a significant step forward in its mission to advance maternal healthcare.
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Discure Technologies Announces $16 Million in Financing Led by BOLD Capital Partners, Supernova Invest and Sanara Capital
Discure Technologies Ltd., developer of the Discure System, a bioelectronic implantable device for the treatment of degenerative disc disease (DDD), announced today that the Company has secured $11 million in an oversubscribed Series A financing round, following a SAFE (Simple Agreement for Future Equity) raise of $5 million, bringing the total equity financing raised to $16 million.
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HEPTA Medical Secures €5.7 Million Series A, Led by BPI France to Advance Minimally Invasive Lung Cancer Treatment
HEPTA Medical (“HEPTA”), a private medical device company dedicated to providing an efficient, safe, and minimally-invasive thermal ablation therapy for early-stage lung cancer, today announced it has successfully raised €5.7M in the first close of its Series A funding round.
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Lungpacer Medical Announces PMA Submission for AeroPace® System
Lungpacer Medical, a neurostimulation company developing interventional therapies to free patients from mechanical ventilation (MV) and improve diaphragm, lung, heart, and brain health, today announced that the Company’s flagship AeroPace System is under Food and Drug Administration (FDA) review in a premarket approval (PMA) application.
Renata Medical Receives FDA Approval for the Minima Growth Stent, First-of-its-Kind Device for Treating Aortic Coarctation and Pulmonary Artery Stenosis
Renata Medical today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s first-of-its-kind Minima Growth Stent that’s specifically tailored for neonates, infants, and young children, but also designed to be re-expanded over the course of their growth period.
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Vitestro Achieves CE Marking for Autonomous Blood Drawing Device
Vitestro, a pioneer in the field of medical robotics, is proud to announce that its innovative automated blood drawing device has received CE marking. This marks a significant milestone for the company, acknowledging that the device meets the requirements of the European Medical Device Regulation (MDR) and is now approved for commercial use across the European Union.
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Two New FDA-Clearances for Sibel Health Enables Compatibility of Advanced Wearable Sensors to 3rd Party Software Solutions
Sibel Health announces two additional FDA-clearances enabling its advanced wearable sensors to operate with compatible third party software applications.
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Universal DX Initiates Clinical Trial for FDA Approval of Signal-C® Colorectal Cancer Screening Blood Test
Universal DX (“UDX”), a biotech company dedicated to transforming cancer into a curable disease by detecting it early, today announced closure of the Series B which funds the clinical trial for its colorectal cancer screening blood test, Signal-C®, aimed at achieving FDA premarket approval.
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PanTher Therapeutics Receives FDA Clearance of IND Application for Phase 1b Study of PTM-101 for the Localized Treatment of Pancreatic Cancer
PanTher Therapeutics (“PanTher” or the “Company”), a clinical-stage oncology company redefining cancer treatment with therapeutics administered continuously and exclusively at the tumor site, today announced the U.S.
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CroíValve raises $16m in Series B for heart valve treatment device
CroíValve, a medtech start-up that spun out of Trinity College Dublin, has closed a $16m Series B funding round led by the MedTech and Irrus Syndicates.
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Wellinks Integrates Virtual Pulmonary Rehabilitation Program at UMass Memorial Health for Massachusetts Residents Living with COPD
Wellinks, a digital healthcare company offering comprehensive value-based solutions for Chronic Obstructive Pulmonary Disease (COPD) management, today announced plans to integrate its pulmonary rehabilitation program at UMass Memorial Health (UMMH) to support people living with Chronic Obstructive Pulmonary Disease (COPD) in Central Massachusetts.
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Prana Thoracic Completes Series A Extension of $3 Million in Oversubscribed Round, Bringing Total Funding to $9 Million
Prana Thoracic, a Houston-based medtech startup, founded with a vision to transform lung cancer intervention, proudly announces the successful final closing of its Series A extension round.
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Centerline Biomedical receives FDA 510(k) clearance for new IOPS® Viewpoint Catheter, further addressing market need to reduce physician exposure to harmful x-ray radiation during image-guided, endovascular procedures
Centerline Biomedical, Inc. (“Centerline”), an innovation leader in cardiovascular navigation and visualization systems, announced today that the IOPS Viewpoint Catheter has received US Food and Drug Administration (FDA) 510(k) clearance.
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Mindera Health Secures $14M to Advance Commercialization of Psoriasis Precision Medicine Test
Mind.Px™ is a proprietary biomarker test that analyzes a patient’s skin sample to determine the optimal treatment path for psoriasis. By identifying the most effective drug class upfront, Mind.Px™ can significantly reduce the time and cost associated with trial-and-error treatment approaches.
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German Medtech Protembis Gets €20 Million EIB Backing for Technology to Protect Brain During Heart Treatment
The European Investment Bank (EIB) is providing €20 million in venture-debt financing to German medical-technology company Protembis to develop a next-generation device for protecting the brains of patients who undergo certain heart treatments.
CMS Establishes National Payment for AI Breakthrough in Prostate Cancer Diagnosis, Unfold AI
Avenda Health, an AI healthcare company creating the future of personalized prostate cancer care, today announces the Centers for Medicare & Medicaid Services (CMS) has assigned a national payment rate for the company’s innovative prostate cancer mapping technology, Unfold AI.
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Edwards Lifesciences to spend $1.2B on two more M&A deals
Edwards Lifesciences is continuing its M&A run with two more major deals. The cardiac device company announced yesterday evening that it will spend $1.2 billion to acquire two companies: JenaValve Technology and Endotronix.
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Sutter Health to deploy Flosonics Medical’s Doppler ultrasound device
US-based integrated healthcare system Sutter Health is set to implement Flosonics Medical’s wireless, wearable Doppler ultrasound device, FloPatch, to enhance the safety of intensive care unit (ICU) patients.
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eCential Robotics Receives FDA 510(k) Clearance for Spine Navigation and Robotic-Assistance Device
ECential Robotics is proud to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an innovative Spine Navigation and Robotic-Assistance Device.
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Nurami Medical Awarded a €2.5 Million EIC Grant to Accelerate Soft Tissue Repair
Nurami Medical, a pioneering developer of soft tissue repair solutions, announced today that it has been awarded blended financing which includes a €2.5 million grant and additional equity investment from the European Innovation Council (EIC) Horizon Accelerator program.
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Vectorious Medical Technologies Announces First U.S. Patient Implanted with the V-LAP Left Atrial Pressure Sensor
A patient in Cincinnati has become the first in the United States to receive an innovative system that enables remote monitoring of his heart and congestion status, as well as self-adjustment of diuretics.
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Innoblative Announces Successful First-in-Human Use of its Novel Electrosurgical Device for Breast Cancer Treatment
Innoblative Designs, Inc. (Innoblative), a private medical device company addressing clinical unmet needs for patients with breast cancer, announced today that it has initiated its first-in-human clinical experience, successfully treating a 64-year-old patient with stage II luminal A breast cancer.
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Neuspera Medical Raises $23 Million in Series D Financing
Neuspera Medical, Inc., a neuromodulation company pioneering the Neuspera Implantable Sacral Neuromodulation (SNM) System, announced the closing of its Series D funding round raising $23 million and led by Vertex Ventures HC and Treo Ventures with participation by Action Potential Venture Capital, Windham Venture Partners, Olympus Innovation Ventures and another strategic investor.
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FDA clears ImmersiveTouch augmented reality surgical system
ImmersiveTouch announced today that it received FDA 510(k) clearance for its ImmersiveAR augmented reality technology platform.Chicago-based ImmersiveTouch’s ImmersiveAR extends the company’s AI-powered suite of virtual surgical planning products and services.
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Endoron Medical raises US$10 million in Series A funding
Endoron Medical has announced the successful closing of its US$10 million Series A funding round. The round was led by Sofinnova Partners, with significant matching contributions from the European Innovation Council Fund (EIC Fund).
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Medasense Announces a Strategic Agreement With Global Medical Company, Nihon Kohden Corporation
Medasense’s CEO & Founder, Galit Zuckerman, expressed enthusiasm about the collaboration: “We are honored to partner with Nihon Kohden, a company with a long history of excellence, that shares our vision of improving patient care through innovative solutions.
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Endotronix Receives FDA Premarket Approval of the Cordella™ PA Sensor System for the Treatment of Heart Failure
Endotronix, Inc., a privately held company dedicated to advancing the treatment of heart failure (HF) at the intersection of digital health and medtech, today announced Premarket Approval (PMA) from the U.S Food and Drug Administration (FDA) of the company’s Cordella™ Pulmonary Artery (PA) Sensor System for the treatment of New York Heart Failure (NYHA) class III heart failure patients.
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Zynext Ventures invests in MRI systems developer Promaxo
Zydus Lifesciences‘ venture capital arm Zynext Ventures has announced a strategic investment in Promaxo, which develops low-field MRI systems. US-based Promaxo is also engaged in the development of minimally invasive robotics.
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Enspectra receives breakthrough status for AI-powered skin imaging platform
Enspectra Health has secured breakthrough device designation (BDD) from the US Food and Drug Administration (FDA) for its AI-powered VIO Skin Platform.
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AvaSure Teams Up with CLEW Medical to Boost High-Acuity Care with AI-Driven Virtual Surveillance
AvaSure, a market leader in acute virtual care, and CLEW Medical, an AI-enabled clinical surveillance and predictive analytics company, announced their partnership to drive early detection of critical care patient deterioration, leading to more timely interventions, reduced complications, fewer readmissions, and decreased mortality.
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Zeto wins FDA clearance for ONE EEG system
US-based medical equipment manufacturer Zeto has received 510(k) clearance from the Food and Drug Administration (FDA) for its electroencephalogram (EEG) system Zeto ONE across hospital, home, ambulance and air transport environments.
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Medable and Masimo partner to bring wearables to clinical trials
Clinical trial technology provider, Medable, has partnered with wearable device firm Masimo to integrate its pulse oximeter technology into clinical trials.
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StrokeDx Raises Oversubscribed $5 Million Seed Prime Round to Advance Next-Generation Stroke Technology
StrokeDx, a pioneer in next-generation stroke technology, today announced the successful closing of $5 million in Series Seed Prime funding. The oversubscribed round was led by DigiTx Partners, with participation by Freeflow Ventures and other existing investors with extensive accomplishments across neuroradiology, stroke, and medical devices.
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Why Mark Cuban And Others Are Betting $40 Million On This Under 30 Start Up featuring Genetesis
Cofounders of Genetesis, left to right: Vineet Erasala, Peeyush Shrivastava and Manny Setegn.COURTESY OF GENETESISVineet Erasala, Manny Setegn and Peeyush Shrivastava are childhood best friends from Cincinnati, Ohio.
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Oxford Endovascular secures £8 million to take novel brain aneurysm tech to human trials
Oxford Endovascular today announces the successful completion of an 8 million GBP Series A+ funding round. The MedTech start-up, founded in 2015, is developing a novel approach to preventing brain haemorrhage by treating intracranial aneurysms.
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MEACOR Secures $15 Million in Series A Funding to Advance Innovative Transcatheter Heart Valve Repair Technology
MEACOR Inc. is pleased to announce the successful closing of its $15 million Series A funding round. This substantial investment supports MEACOR’s mission to offer a novel transcatheter approach for the treatment of mitral and tricuspid valve regurgitation.
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May Health Raises $25 Million in Series B Funding to Advance Development for Ovarian Rebalancing Therapy
May Health, a clinical-stage medical device company dedicated to helping those living with the endocrine disorder polycystic ovary syndrome (PCOS), today announced it has closed a $25 million Series B financing round, co-led by Bpifrance and Trill Impact with participation from founding investor Sofinnova Partners, as well as Avestria Ventures and Kidron Capital Assets LP.
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CLEW Medical Scores FDA Clearance for Next-Gen AI-Powered Patient Deterioration Prediction
– CLEW Medical, a provider of AI-driven clinical surveillance and predictive analytics, has achieved a breakthrough with FDA 510(k) clearance for its second-generation AI models for predicting patient deterioration.
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Meet the medical device company that won a $100,000 business pitch competition featuring SafePush
A Metairie-based company that makes disposable devices to regulate the flow of medication won the Baton Rouge Entrepreneurship Week business pitch competition Thursday evening.
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Healionics Awarded $1.25M NIH Grant to Support Commercialization of STARgraft Vascular Graft
Healionics Corporation, a developer of biomaterial-based medical devices, today announced it has been awarded a $1.25 million Small Business Innovation Research grant by the National Heart, Lung, and Blood Institute to support the commercialization of its STARgraft vascular graft.
Avenda touts study results of Unfold AI
AI healthcare firm Avenda Health is touting the results of a study showing how the company’s Unfold AI can identify prostate tumor margins and predict the efficacy of focal therapy treatments.
Little Sparrows Technologies Raises $3M Series Seed Round, Announces New Board Members
Little Sparrows Technologies, a neonatal medical device startup and innovator of the award-winning, FDA cleared jaundice treatment, bili-hut™ phototherapy, today announces the addition of three members to its Board of Directors following the successful close of a $3M Series Seed funding round.
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Xealth & Stel Life Partner to Simplify Remote Patient Monitoring with Secure Data Integration
– Xealth, a digital health platform provider, today announced a collaboration with Stel Life, a frontrunner in health monitoring device connectivity.
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Averto Medical Debuts with Oversubscribed $30M Series A Financing to Advance Innovative Medical Device that Avoids Need for Ostomy
Averto Medical Inc (“Averto”, “The Company”), a clinical-stage medical device company pioneering minimally invasive gastrointestinal care, today announced the closing of an oversubscribed $30.5 million Series A financing.
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Remote Pregnancy Care Innovator Nuvo Group Ltd. Becomes Public Company Through Completion of Business Combination with LAMF Global Ventures Corp.
Company Will Begin Trading on NASDAQ Under Ticker Symbol NUVO as of Thursday May 2, 2024
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Caretaker Medical Unveils VitalStream Roadmap for Streamlined Cardiogenic Shock Monitoring at SCAI 2024
Caretaker Medical, a leading innovator in advanced hemodynamic monitoring solutions, today announced the launch of its VitalStream® Cardiogenic Shock Continuous Monitoring Roadmap at the Society for Cardiovascular Angiography and Interventions (SCAI) 2024 meeting.
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Starlight Cardiovascular Awarded $2M NIH SBIR Phase II Grant to Develop Pediatric Cardiology Device
Starlight Cardiovascular, Inc., a company developing pediatric cardiovascular medical devices, announced that it has been awarded a Small Business Innovation Research (SBIR) Phase II grant from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) to advance development of its Pulmonary Flow Restrictor.
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Vitestro Secures $22M for Autonomous Blood Draw Device
Vitestro Secures Oversubscribed Funding Round to Drive European Expansion and U.S. Market Entry
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First adult spine surgery using groundbreaking nView s1 imaging and navigation technology announced
NView medical, a leader in surgical imaging technologies, proudly announces the successful first use of its nView s1 imaging and navigation system in adult spine surgery.
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Provisio Medical Announces FDA Clearance of the Provisio SLT IVUS™ System
Provisio Medical today announced FDA 510(k) clearance of the Provisio™ SLT IVUS™ System. Sonic Lumen Tomography (SLT) technology addresses a critical unmet need for vascular specialists by providing automatic, real-time, accurate, numeric measurements of the flow lumen of blood vessels without the complexities of image interpretation.
Atacor Medical Closes $28m Series C Financing to Deliver Next Generation Extravascular ICD And Pacing Options for Cardiac Rhythm Management
AtaCor Medical Inc., a privately-held medical device company delivering the next generation of extravascular leads to advance the care of cardiac rhythm management (CRM) patients, announced today that it has completed a $28M Series C financing round.
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FDA clears Epitel remote monitoring tech, AI detection platform
Epitel announced today that it received FDA 510(k) clearance for two new patient-focused brain health offerings. The FDA cleared the Remi remote EEG monitoring system for ambulatory use and the Remi Vigilenz AI for event detection.
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Sibel Health awarded a major grant to advance maternal monitoring solution for low-and-middle income countries.
Sibel Health, an award-winning health technology company backed by the Steele Foundation for Hope, announced it has received a $17.5 million dollar grant from the Bill & Melinda Gates Foundation to advance the use of its FDA-cleared wireless monitoring solution, ANNE® One, for labor triage and continuous maternal health monitoring in low-and-middle income countries (LMICs) to reduce obstetrical morbidity and mortality.
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Forcen Closes $8.35 Million in Funding to Develop Its Touch-Tech for Robots
Toronto-based robotics sensing company Forcen has closed an $8.35 million CAD funding round as it looks to scale up its prototype production facilities.
Hyalex announces first patients’ treatment in knee cartilage system trials
Hyalex Orthopaedics has announced the successful treatment of the first patients in the first-in-human clinical trials with its HYALEX Knee Cartilage System.
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Genesis Growth Tech Files Proxy on MindMaze Deal
Genesis Growth Tech Acquisition filed a proxy and prospectus on its $21 million deal with MindMaze, a digital therapeutics firm. The sponsor is obligated to pay MindMaze the $21 million purchase price by May 31.
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Titan Medical progresses with Conavi merger
Titan Medical today provided a progress update regarding its planned merger with surgical guidance technology company Conavi Medical. The companies entered into a definitive amalgamation agreement to combine in an all-stock transaction last month.
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Beating Heart Disease: How ConKay leads the charge against Valvular Regurgitation?
“Our purpose goes beyond technology. We’re driven by a profound commitment to changing lives.”
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Raydiant Oximetry Secures FDA Approval for Lumerah Investigational Device Exemption (IDE) Study
Raydiant Oximetry, Inc., a clinical-stage medical device company that develops medical technologies to improve outcomes for mothers and babies during childbirth, announces that the United States Food and Drug Administration (FDA) has approved the Investigational Device Exemption (IDE) of the Lumerah™ technology for an Early Feasibility Study (EFS) of pregnant women during labor and delivery.
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Liberate Medical Announces PREVENT Study with $6.5M Grant Funding from the US DoD – Enrolls First Patients Globally
Liberate Medical is proud to announce the successful commencement of patient enrollment in the PREVENT trial, a pivotal clinical trial examining the VentFree Respiratory Muscle Stimulator.
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Neurotech startup Neurovalens gets FDA clearance for noninvasive anxiety treatment
A 2019 rule change by the U.S. medical devices regulator aimed at encouraging innovations targeting insomnia and anxiety is bearing fruit: Neurovalens, a Belfast-based startup that for over a decade has been developing technology to deliver noninvasive electrical stimulation of the brain and nervous system, has just had its second head-mounted treatment device cleared by the FDA.
Onkos Surgical Announces First FDA De Novo Approval of an Antibacterial Coating for Tumor and Revision Orthopaedic Implants
Onkos Surgical, an orthopaedic company founded to address the complex clinical challenges associated with bone loss due to tumor, trauma, and revision surgery, announced that the U.S.
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Titan Medical Merges with Conavi Medical
Titan Medical Inc. (“Titan”) announced on March 18, 2024, that it is merging with Conavi Medical Inc. (“Conavi”). Titan is a medical technology licensing company based in Toronto with an extensive patent portfolio focusing on robotic assisted surgery.
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Politico Future Pulse Newsletter featuring Limax Biosciences
Researchers envision using the gel to attach medical devices to organs and eventually engineering it to dissolve after the body heals from an injury. They’ve also formed a startup, Limax Biosciences, to commercialize their technology.
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Biolinq Raises $58 Million to Advance Wearable Biosensors Through Pivotal Trial for Metabolic Health Using Precision Microsensor Technology
Biolinq Incorporated, a healthcare technology company pioneering precision multi-analyte biosensors to improve metabolic health, today announced the completion of $58 million in financing led by Alpha Wave Ventures, with participation from Niterra’s corporate venture capital fund jointly operated with Pegasus Tech Ventures and existing investors RiverVest Venture Partners, AXA IM Alts, Global Health Investment Corporation, Aphelion Capital, Senvest Management, Features Capital and Taisho Pharmaceutical.
Eko Health Gains FDA Clearance For Cardiology Algorithm That Can Detect Heart Failure in 15 Seconds
Eko Health received FDA clearance this week for a new AI-powered tool that aids in the early detection of low ejection fraction, a key indicator of heart failure.
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FDA authorizes Prenosis software as first AI tool that can diagnose sepsis
The health technology company Prenosis on Wednesday announced its artificial intelligence-powered diagnostic tool for sepsis is the first to receive approval from the U.S.
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Neurava raises over $2M to advance life-saving epilepsy monitoring device
Neurava announced that it has completed and oversubscribed its Series Seed round, raising $2.26 million. Neurava is developing novel and innovative wearable devices for the estimated 3.5 million Americans and 65 million people worldwide with epilepsy to mitigate the risk of SUDEP, or Sudden Unexpected Death in Epilepsy.
Genetesis Announces Formal Publication of Results from the MAGNETO Trial
Genetesis, Inc., a leader in the field of magnetocardiography (MCG), today announced that official results from its MAGNETO trial were published in a special issue of the American Heart Journal Plus: Cardiology Research and Practice.
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Photopharmics kickstarts phototherapy trial for Parkinson’s disease
US-based equipment manufacturer Photopharmics has announced the initiation of its ‘Celeste light for PD’ clinical trial investigating the Celeste phototherapy device.
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Meet the 2024 $200K Challenge Finalists featuring Relavo Medical
A disinfecting connection device that reduces infection risk associated with dialysis.
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FormaPath announces the novel tissue biopsy grossing platform: nToto™
In conjunction with a poster presentation at the United States and Canada Association of Pathologists Annual (USCAP) meeting titled “Current State of Intra-/Interobserver Accuracy and Reproducibility in Tissue Biopsy Grossing and Comparison to an Automated Vision System”
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Protembis raises $32.6M, adds Shockwave exec to board
Cardiovascular medical device maker Protembis announced today that it completed a $32.6 million (€30 million) Series B financing round. The Aachen, Germany-based company plans to use the funds to support enrollment for its PROTEMBO FDA investigational device exemption (IDE) trial.
Built in Baltimore: CoapTech, Inc. Announces Market Launch of its Second Generation Magnetic Balloon Catheter for the PUMA-G System
, CoapTech, Inc., a medical device company delivering transformative solutions for minimally-invasive surgery, announced today the market launch and historic first bedside use case of its second generation magnetic balloon catheter.
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Flosonics Medical Secures $20 Million USD in Series C Funding Led by New Leaf Venture Partners to Accelerate Growth
Flosonics Medical, a leader in wearable medical ultrasound, today announced its Series C financing, raising $20 million USD. The round was led by New Leaf Venture Partners, with participation from previous investors Arboretum Ventures, Genesys Capital, and iGan Partners.
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Titan Medical enters merger with Conavi Medical
Titan Medical announced today that it entered into a definitive amalgamation agreement to combine with Conavi Medical.
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ConKay Medical Systems Raises $1.8M in Oversubscribed Seed Funding Round
ConKay Medical Systems, a medtech start-up company developing a unique device for treating patients suffering from valvular regurgitation, has closed an oversubscribed $1.8M seed round.
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SafeGuard Surgical Receives FDA “Breakthrough” Designation, Secures Funding from Tom Pepin and NFL QB Jameis Winston
SafeGuard Surgical, a leading medical technology company focused on life-saving biodegradable solutions, announced today a major milestone in its mission to improve global healthcare.
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Gradient Denervation Technologies Enrolls First Patient in Early Feasibility Study of Pulmonary Artery Denervation System
Gradient Denervation Technologies, a Paris-based medical device company developing a minimally-invasive, ultrasound-based device designed to treat pulmonary hypertension patients with associated heart failure, announced today that the Food and Drug Administration (FDA) has approved the initiation of the PreVail-PH2 Early Feasibility Study in the United States.
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Bloomlife and Valley Perinatal Services Partner to Transform High-Risk Maternal Care
Bloomlife, an award winning women’s health company, and Valley Perinatal Services (VPS), Arizona’s leading high-risk maternal fetal medicine group, today announced a commercial partnership along with results from the initial deployment of Bloomlife’s remote maternal care platform Bloomlife Connects.
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Bone Health Technologies Raises $5M to Advance Osteopenia Treatment
Bone Health Technologies (BHT) has recently closed a $5 million funding round to enhance care for individuals with low bone density. This round saw contributions from Esplanade Ventures, Berkeley Catalyst Fund, and Terumo Medical, a global leader in medical technology.
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Phagenesis raises $42m to take medical device for swallowing disorders to the US
K medtech startup Phagenesis has raised a $42m Series D to roll out its medical device for swallowing disorders in the US and expand its footprint in Europe.
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Augment Health announces investment from Vanderbilt University as part of latest funding round
Augment Health, Inc., a medical technology company developing next generation urologic monitoring tools for patients with chronic conditions, recently announced an investment from Vanderbilt University’s Innovation Investment Committee (“IIC”).
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Healionics Closes $5.5 Million Series A-3 Financing Round
Healionics Corporation, a developer of biomaterial-based medical devices, today announced the close of a $5.5 million equity financing round led by Keiretsu Capital with participation by several prominent angel groups.
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Tasso Announces One Million Device Milestone
Last week we accomplished a huge milestone and shipped our one millionth device. This was an incredible moment for our company as a whole and something that was hard to imagine when we first started out nearly 12 years ago.
InkSpace Imaging Announces a Strategic Distribution Partnership with American Medical Imaging
InkSpace Imaging announced a strategic distribution partnership with American Medical Imaging (AMI), a leading US distributor of medical imaging equipment.
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Irish medtech star Pumpinheart to raise €5 million in seed funding
Pumpinheart, a medtech start-up based between Dublin and Galway, expects to raise a €5 million seed funding round later this year. The investment will fine tune its technology designed to help people with heart failure.
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FDA Clearance of VerTouch™ from IntuiTap Medical Could Revolutionize Epidurals
IntuiTap Medical proudly announces FDA clearance of their cutting-edge medical device, VerTouch. VerTouch eliminates the guesswork from spinal punctures making them more accurate and consistent.
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Sibel Announces its 4th FDA Clearance for Continuous Wearable Vital Signs Monitoring with ANNE® One and Additional Strategic Collaboration with Ann & Robert H. Lurie Children’s Hospital of Chicago
Sibel Health, a leading digital health company, announced today that its continuous wearable monitoring solution, ANNE® One, has received another 510(k) clearance from the U.S.
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Think Big, Start Small, and Prioritize Ruthlessly: Interview with InterShunt CEO Harlee Sorkin featuring InterShunt
Harlee Sorkin is a co-founder of Common Place Holdings, a venture studio that has given birth to eight different medtech startups, including InterShunt, which Harlee is leading as its CEO today. Prior to that, Harlee proved his business acumen by leading Traco Labs to a successful exit.
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DASI Simulations closes $5 million convertible note funding round
DASI Simulations, a medical technology start-up offering a novel AI-powered medical platforms to advance toward lifetime management and improved outcomes for structural heart interventions, has closed it $5 million convertible note round. The company has now surpassed $7 million in funds raised.
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Denmark’s Neurescue raises €6.7M to develop cardiovascular devices to help emergency patients
Copenhagen-based Neurescue, a medical device startup that claims to pioneer an improved treatment of cardiac arrest, has secured DKK 50M (approximately €6.7M) in a Series A round of funding.
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Galway-based Mirai Medical secures financing ahead of seeking FDA approval
Mirai Medical, a medtech company pioneering an energy technology for use in the treatment of cancer, has secured €4 million in funding.
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Funding of €6.8 million announced for sustainable disruptive technology
Minister for Enterprise, Trade and Employment, Simon Coveney TD, Minister for Further and Higher Education, Research, Innovation and Science, Simon Harris TD and the Minister of State for Trade Promotion, Digital and Company Regulation, Dara Calleary TD, today announced funding of a further €6.8 million for a twelfth project under Call 6 of the Disruptive Technologies Innovation Fund (DTIF).
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Caira Set to Change How We See Knee Surgery: Vanguards of Health Care
Caira Surgical is innovating radar technology to make it precise enough for use in navigating surgeons through knee replacement procedures, where every millimeter matters for an accurate outcome, co-founders Jon Greenwald and Mort Meftah explain to Bloomberg Intelligence.
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Trinity College spin-out aims to make colon cancer surgery safer and improve long-term patient outcomes
When surgeons remove a diseased part of the intestine during gastric surgery, the reconnection of the two healthy ends, usually with suturing or stapling, is called an anastomosis.
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NetScientific’s Glycotest secures US$1m follow-on investment from Fosun
NetScientific, a deep tech and life sciences venture capital investment group, announced that its portfolio company Glycotest has secured a US$1m follow-on investment from Fosun Industrial.
Bone Health Technologies’ Osteoboost Cleared by FDA
The U.S. Food and Drug Administration (FDA) has granted clearance for Bone Health Technologies’ Osteoboost, a non-pharmacological device-based prescription treatment for postmenopausal women diagnosed with osteopenia (low bone density).
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Osso virtual reality training academy adds 5 orthopedic modules
Immersive surgical training program company Osso VR has added five new orthopedic training modules to its Osso Academy, a virtual reality medical training library.
FDA Clearance Granted for First AI-Powered Medical Device to Detect All Three Common Skin Cancers (Melanoma, Basal Cell Carcinoma and Squamous Cell Carcinoma)
DermaSensor Inc. announces FDA clearance for its real-time, non-invasive skin cancer evaluation system. For the first time, the 300,000 primary care physicians in the U.S.
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Bloomlife Announces FDA Clearance of Bloomlife MFM-Pro
Bloomlife, the award winning maternal health company, has received clearance from the US Food and Drug Administration (FDA) for Bloomlife MFM-Pro, their first maternal and fetal monitoring device.
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InkSpace Imaging receives FDA Clearance for a 24-channel Small Body Array Compatible with Siemens Healthineers 3T Systems
InkSpace Imaging, a leader in innovative diagnostic medical device technology, is proud to announce it received FDA clearance for its next-generation Small Body Array for the Siemens Healthineers Magnetom Skyra and Vida series 3T MRI scanners.
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FDA grants first clearance to AI program for diagnosing idiopathic pulmonary fibrosis
The artificial intelligence developer Imvaria has claimed a de novo clearance from the FDA for a digital diagnostic that analyzes chest CT scans for the signs of idiopathic pulmonary fibrosis.
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Sonavex Announces Successful Clinical Study of EchoMark & EchoSure and Initiation of the MAFASA Randomized Controlled Trial
FDA IDE approval of Sonavex’s randomized trial comes months after meeting the endpoint of its first clinical study
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Darmiyan Receives FDA Approval for BrainSee, the First Prognostic Test for Predicting Likelihood of Progression to Alzheimer’s Dementia
Today marks a turning point in the battle against Alzheimer’s disease as Darmiyan, Inc., a leading company in brain health innovation announces the FDA’s approval of its first-in-class (De Novo) clinical test, BrainSee.
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Distalmotion, Proximie partner for robotic surgery platform extension
istalmotion has announced a partnership with Proximie, a health technology platform, to globally extend the capabilities of its Dexter robotic surgery system.
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Dental robotics company Neocis raises $20M
Neocis, maker of surgical technology for robot-assisted dental implants, announced today that it raised $20 million in additional funding. Maimi-based Neocis received investments from Mirae Asset Capital/Mirae Asset Venture Investment.
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Linear Health Sciences Awarded IV Therapy Products – Needleless Connectors Agreement with Premier, Inc.
Linear Health Sciences has been awarded a national group purchasing agreement for the IV Therapy – Needleless Connectors category with Premier, Inc. Effective Jan.
Medable’s Intelligent Automation Capabilities Reduce Clinical Trial Technology Deployment Timelines
Medable Inc., the leading technology provider for modern clinical trials, announces new intelligent automation technology applied across its clinical trials platform to cut standard trial build timelines by at least half.
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Knowtex and 4D EMR Announce Groundbreaking Partnership to Revolutionize Clinical Workflow with Specialty-Specific Voice and Generative AI EMR System
Knowtex and 4D EMR, two innovative leaders in medical technology, are thrilled to announce a pioneering partnership that will introduce the first specialty-specific voice and generative AI electronic medical records (EMR) workflow.
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FDA grants breakthrough device designation for Renovos’ bone graft gel
UK-based Renovos Biologics has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for Renovite BMP-2 (bone morphogenic protein 2), a synthetic nanoclay bone fusion gel.
Nanowear Announces FDA 510(k) Clearance for AI-enabled Continuous Blood Pressure Monitoring and Hypertension Diagnostic Management: SimpleSense-BP
Nanowear, a leader in healthcare-at-home remote diagnostics, announced that its nanotechnology-enabled wearable and software platform, SimpleSenseTM, has received FDA 510(k) clearance for a novel AI-enabled Software-as-a-Medical Device (SaMD).
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Bloomlife and PeriGen Partner to Improve Access to Critical Maternal and Fetal Health in the Face of Maternity Care Deserts
Bloomlife, an award-winning maternal health company, and PeriGen, the market leader in applying artificial intelligence to improve safety in childbirth, today announced a partnership to improve access to essential monitoring of high-risk pregnancies.
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Enspectra Health Announces US FDA Clearance of VIO™ System, First of Its Kind Technology to Visualize Skin Cellular Structures in Real-Time
Enspectra Health, a health tech company, announces US FDA 510(k) clearance of the VIO System, launching a new era in noninvasive imaging. VIO, the first of its kind technology, combines reflectance confocal and multiphoton microscopy to enable cellular resolution, cross-sectional imaging of skin in seconds.
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Medicare OK clears sales hurdle for heart surgery simulation software
Medicare will now reimburse nearly $1,000 per procedure for heart surgery planning software from an Ohio State University spinoff – clearing a hurdle for increasing sales to hospitals.
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Teijin Limited Signs Joint R&D Agreement with Garwood Medical Devices
Garwood Medical Devices, a breakthrough New York medtech company, and Teijin Limited, a leading Japanese conglomerate with pharmaceutical and implantable medical device businesses, have announced a joint research and development agreement designed to enable Garwood and Teijin to bring Garwood’s novel infection control technology to Japan.
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Galway medtech breakthrough firm SymPhysis raises €1.5m
SymPhysis Medical has received €1.5m in funding and is seeking an additional €4.5m-plus early next year to support the continued development of its breakthrough medical device, FDA approval and the creation of new jobs.
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Sentante Secures €6 Million in New Funding to Revolutionize Endovascular Care
Sentante, a pioneering medical device company headquartered in Lithuania, announces the closing of a €6 Million seed funding round led by Practica Capital with participation of EIC fund.
GT Medical enhances GammaTile Therapy with Cesium-131 seed business acquisition from Isoray Medical
USA —GT Medical Technologies, a US-based medical equipment manufacturer, has agreed to acquire the radioactive Cesium-131 seed business and its infrastructure from Isoray Medical, a subsidiary of Perspective Therapeutics.
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Encellin Closes $9.9M Financing Led by Khosla Ventures to Advance Cell Encapsulation Platform for Endocrine Disorders
Encellin, a biotechnology company developing a cell encapsulation platform with an initial focus on Type 1 Diabetes (T1D), announced the closing of a $9.9M financing round led by Khosla Ventures, with participation from Y Combinator.
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Gravitas Medical Inc. Announces SECOND FDA Breakthrough Device Designation for its Entarik System; Pediatric Patients to Benefit from Enteral Nutrition Innovation!
Gravitas Medical Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted a second Breakthrough Device Designation to Entarik, the innovative Enteral Feeding System.
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Xpan secures FDA 510(k) clearance and announces successful completion of initial human clinical cases in the United States
Xpan Inc., a medical device company focused on minimally invasive surgical innovation, is proud to announce 510(k) clearance from the U.S. Food & Drug Administration for the XpanTM Universal Trocar System, and successful completion of initial clinical procedures in the United States.
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Vivante’s GIThrive Becomes First Digestive Health Platform Selected for The Evernorth Digital Health Formulary
Digital digestive health solution provider Vivante Health today announced the addition of its GIThrive solution to the Evernorth Digital Health Formulary, which connects employers, insurers, and customers with innovative, affordable, and evidence-based care that meets their broader health care needs.
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Movn Health Selected as Winner of Point32Health’s Second Innovation Challenge
Point32Health, the parent company of Harvard Pilgrim Health Care and Tufts Health Plan, has announced Movn Health as the winner of its second annual Innovation Challenge.
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OtoNexus Medical Technologies Selected for Elite FDA STeP Program
OtoNexus Medical Technologies, the developer of the Novoscope ultrasound otoscope for immediate and automatic differentiation of bacterial middle ear infections, is excited to announce its recent selection into U. S. Food and Drug Administration Safter Technologies Program (STeP).
Bone Health Technologies Earns 4th Patent for Osteoboost Device
Bone Health Technologies (BHT), an innovator in health technologies to improve bone health, has been granted its fourth patent to further its commercialization of the Osteoboost device, which has been shown in clinical trials to reduce the loss of bone mass in post-menopausal women.
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Nitinotes Surgical in Full Swing: Impressive Board Appointment, Over 90 Patients Treated, 400+ Sutures Performed, and a $10.1M Series B Funding Round Closure
Nitinotes, developers of EndoZip™, a revolutionary, fully automated suturing device, announced the appointment of Mr. John Barr as the new Chairman of the Board of Directors.
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Medtech startup focuses on a real pain point featuring Sparta Biomedical
The human knee is a marvel. It’s the hinge at the center of our gait, the evolutionary adaptation that makes humans the only fully bipedal mammals on the planet.
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Bright Uro Announces $23M Series A Funding Round Led by Laborie – Expands Senior Leadership Team to Accelerate Next Phase of Commercialization
Bright Uro, a medical device company with a mission to transform care for lower urinary tract symptoms (LUTS) through innovations in urodynamics, today announced the initial closing of its $23M Series A financing round led by Laborie Medical Technologies, a leading global provider of urology diagnostic and therapeutic solutions.
Inflammatix Receives Breakthrough Device Designation from FDA for TriVerity™ Acute Infection and Sepsis Test System
Inflammatix, Inc., a pioneering molecular diagnostics company, announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s lead product, the TriVerity™ Acute Infection and Sepsis Test System.
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FormaPath (formerly Parker Isaac Instruments) Announces Advancement in Cancer Pathology With the Launch of AdiPress
Today, FormaPath announced the commercial launch of AdiPress, the first and only automated tool to standardize lymph node dissection. With this innovation, cancer-focused pathology practices can now automate the recovery of lymph nodes within fatty cancer tissue, to ensure more precise staging of cancer patients to guide their follow up therapy intended to prevent cancer recurrence.
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Savage Medical Exits Stealth With Over $3 Million to Enable Minimally Invasive Colorectal Tumor Removal
Savage Medical, Inc. (“SavageMed”, “Company”, “We”, or “Us”), a San Francisco Bay Area-based, clinical-stage medical technology company enabling minimally invasive colorectal tumor removal, today announced a launch out of stealth with over $3 million in total funding, including oversubscribed financing from leading early-stage medical technology investors including Synergy Ventures, Life Science Angels and AlwaysraiseVC.
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Pristine Surgical fully launches single-use arthroscope in the U.S.
Pristine Surgical announced today that it accelerated the launch of its first-of-its-kind Summit 4K single-use surgical arthroscope.Summit combines a 4K single-use surgical arthroscope with the company’s cloud-based software Pristine Connect. The device provides a high-definition image every time.
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Kheiron’s AI Tool Mia Increases Breast Cancer Detection Rate by 13%, Nature Study Reveals
UK-based cancertech company Kheiron has made a significant leap in the fight against breast cancer with their AI tool, Mia, as evidenced by a recent study published in Nature Medicine.
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Genesis Growth Tech Acquisition Inks $21M Deal with MindMaze
Genesis Growth Tech Acquisition in an 8-K said it entered into a business combination agreement with digital therapeutics firm Mind Maze for $21 million.
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Universal DX Announces Strategic Collaboration with Quest Diagnostics to Bring Advanced Colorectal Cancer Screening Blood Test to Patients and Providers in the United States
Universal DX (“UDX”), a biotech company on a mission to transform cancer into a curable disease, today announced a strategic collaboration with Quest Diagnostics (“Quest”) (NYSE: DGX), the nation’s leading provider of diagnostic information services, designed to improve colorectal cancer screening in the United States – for which more than 110 million people may be eligible.
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Innovative Research, Inclusive Trials, and New Funding Drives Hope for People with Parkinson’s Disease featuring PhotoPharmics
This investment is a pivotal moment in our journey to transform the treatment landscape for Parkinson’s disease.”— Kent Savage, CEOAMERICAN FORK, UT, UNITED STATES, November 15, 2023 /EINPresswire.com/ — PhotoPharmics, an innovator in Parkinson’s disease research and treatment, today announced the successful first close of an $16 million investment round.
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Sonic Healthcare Agrees US$150 Million Acquisition of Pathology Watch
Sonic Healthcare acquired Utah-based medical-tech provider Pathology Watch for US$150 million in what the Australian company called a strategic move that would accelerate its transition to digital pathology services.
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Koya Medical Raises New Capital with OrbiMed to Support Growth
OrbiMed, a leading healthcare investment firm and Koya Medical, a healthcare company with a mission to transform venous and lymphatic treatments through novel, people-centric solutions, today announced the closing of a financing for up to $30 million.
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Oxford Nanopore and Day Zero Diagnostics Partner to Develop a New Class of Bloodstream Infection Diagnostics
Oxford Nanopore, the company delivering a new generation of nanopore-based molecular sensing technology, and Day Zero Diagnostics (DZD), an infectious disease diagnostics company harnessing the power of whole-genome sequencing and AI to combat the rise of antibiotic-resistant infections, today announced a collaboration to develop an end-to-end solution for the diagnosis of bloodstream infections, a leading cause of sepsis.
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Neurent Medical Announces New CPT Code® for Chronic Rhinitis Treatment Offering Significant Symptom Improvements
Neurent Medical, a company pioneering innovative non-surgical interventions to treat chronic inflammatory sinonasal diseases, today announced a significant milestone for the chronic rhinitis market.
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Remote Medication Monitor Receives Funding from Rady Venture Fund featuring Cari Health
he Rady Venture Fund, a student-assisted venture capital investment fund, established at the Rady School of Management in 2009 to support the school’s educational and entrepreneurial objectives, is proud to announce its newest investment: CARI Health.
Avenda Health’s Revolutionary AI Mapping Tool for Prostate Cancer Achieves Landmark Category III CPT Code Designation
The American Medical Association (AMA) has announced its 2024 Current Procedural Terminology (CPT) code set will include a new Category III code for Avenda Health‘s innovative Unfold AI™, a cancer AI platform that creates new clinically meaningful insights to aid physicians and patients in making informed treatment decisions.
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Inari Medical plans to buy LimFlow Medical for up to $415M
Inari Medical (NASDAQ: NARI)+ today announced a definitive agreement to purchase LimFlow Medical for up to $415 million. The deal comes just weeks after Paris-based LimFlow won FDA premarket approval (PMA) for its breakthrough system to treat chronic limb-threatening ischemia (CLTI).
Access Vascular to Ramp Production With $22 Million Series C Financing
Access Vascular, Inc. (AVI), a company addressing the most common and costly vascular access complications with its advanced biomaterial platform, today announced that it raised a Series C round worth $22 million from a consortium of new and existing investors.
FDA clears non-invasive insomnia-treating device from Neurovalens
Neurovalens announced today that the FDA granted clearance to its Modius Sleep device for treating chronic insomnia.Belfast, Northern Ireland-based Neurovalens develops non-invasive neurotechnology. The company took part in the MedTech Innovator Accelerator program last year.
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AMA Issues CPT Code for EchoSure
CPT Code establishes a standard reimbursement pathway for the EchoSure System effective July 1, 2024
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Alyve Medical Announces Publication of Clinical Trial on Neuralign S in the Treatment of Posterior Shoulder Instability
Alyve Medical Inc., a global medical technology company and leader in data-driven joint kinematics tools and personalized neuromuscular electrical stimulation (NMES) technologies, announced today the publication of results from an independent multi-center randomized controlled trial evaluating the safety and efficacy of Neuralign S™ (formerly known as Shoulder Pacemaker) in the treatment of functional posterior shoulder instability.
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The Best Inventions of 2023: Improving Stroke Recovery MicroTransponder Vivistim Paired VNS System
MicroTransponder’s Vivistim Paired VNS system is a chest implant that helps chronic ischemic stroke survivors regain impaired motor function in their arms and hands by stimulating the nearby vagus nerve, the body’s “superhighway”
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Day Zero Diagnostics Names Jeff Mirviss Chair of Board of Directors
Day Zero Diagnostics Inc. (DZD), an infectious disease diagnostics company harnessing the power of whole-genome sequencing and AI to combat the rise of antibiotic-resistant infections, announced today that independent board member, Jeff Mirviss, has been appointed board chair.
Moon Surgical announces first commercial Maestro surgical robot cases in France
Moon Surgical today announced the successful completion of the first 10 laparoscopic surgeries with its Maestro system in France.The procedures — bariatric and abdominal surgery procedures — took place at the Arnault Tzanck Institute in Nice, France.
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Conavi Medical Announces Limited Market Release of the Novasight Vantage Hybrid Imaging System
Conavi Medical Inc., (“Conavi” or the “Company”) developer of the Novasight Hybrid System and a leader of hybrid imaging guidance for minimally invasive cardiovascular interventions, today announced the limited market release for their new Novasight Vantage hybrid imaging system in the U.S.
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Protembis Announces FDA Approval of its Pivotal Investigational Device Exemption (IDE) Study
Protembis GmbH (Protembis) a privately-held emerging cardiovascular medical device company, announced today the FDA has approved the PROTEMBO Pivotal IDE Trial (NCT05873816).
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Sidekick Health acquires PDTx company and more digital health announcements
Digital care management platform Sidekick Health announced it acquired Hamburg-based aidhere, a prescription digital therapeutic for people with obesity.
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Senzo Health Raises Additional $1.8M in Funding
Senzo Health, a London, UK-based life sciences company developing diagnostic technologies, raised additional $1.8M in funding.
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ZKR Orthopedics announces FDA Breakthrough Device designation for the LIFT Implant Technology
ZKR Orthopedics, Inc., a clinical stage medical device company, today announced that its LIFT implant technology has been granted Breakthrough Device Designation by the U.S.
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Endotronix Receives IDE Approval for the Market Expanding PROACTIVE-HF 2 Clinical Trial
Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), announced it has received Investigational Device Exemption (IDE) approval from the FDA for a subsequent multicenter study, PROACTIVE-HF 2, which will evaluate the company’s Cordella Sensor for pulmonary artery (PA) pressure-guided therapy.
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Rhaeos, Inc. Receives $1.5 Million Blueprint MedTech Grant from the NIH to Transform Hydrocephalus Management
Rhaeos, Inc, a clinical stage medical device technology company, is pleased to announce that it has been awarded a $1.5 million grant (Federal Award # 1UG3NS130338) from the National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS) through its Blueprint MedTech program.
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RevBio Awarded a $3.4 Million NIH Grant for Its Novel Regenerative Bone Adhesive to Treat Complex Fractures
RevBio, Inc., announced that it has been awarded a grant from the National Institute on Aging (NIA), part of the National Institutes of Health (NIH), through its Commercialization Readiness Program of up to $3.4 million over the next three years (1SB1AG085803-01).
Promaxo Receives Direct Investment from Surgical Robotics Industry Pioneer Fred Moll and Announces Appointment as Strategic Advisor
Promaxo, Inc. (“Promaxo” or the “Company”), a medical imaging, robotics, and AI technology company, announced today that it has received a direct investment from Fred Moll, M.D., industry pioneer and leader in surgical robotics and minimally invasive surgery, with more than 40 years of experience of building and leading innovative medical device companies.
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French VR therapy provider HypnoVR strengthens market hold with Oncomfort acquisition
French VR-based digital therapy provider HypnoVR has acquired Belgian digital sedation company Oncomfort. The financials of the deal have not been disclosed.
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Anumana wins FDA clearance for ECG-AI algorithm
Anumana announced that it received FDA 510(k) clearance for its AI-powered ECG-AI LEF medical device.
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Addressing the Cost vs. Quality Conundrum: 3EO Health Receives FDA Emergency Use Authorization, Launches Groundbreaking Point of Care Technology
3EO Health, a “Point of Life” diagnostics company focused on the development of high-performing low-cost molecular diagnostics for both point of care and at-home testing announced today the receipt of an emergency use authorization (EUA) for its SARS-CoV-2 molecular test.
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Alyve Medical Awarded Most Fundable Company Recognition by Pepperdine Graziadio Business School
Alyve Medical, a global medical technology company and leader in data-driven joint kinematics tools and personalized neuromuscular electrical stimulation (NMES) technologies, is delighted to announce that it has achieved Silver recognition on the Pepperdine Graziadio Business School’s sixth annual Most Fundable Companies® List.
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Strados Labs Announces Pediatric Asthma Study to Validate its Wearable Device in Children with Wheeze
Strados Labs has partnered with Ann & Robert H. Lurie Children’s Hospital of Chicago for a clinical trial to evaluate the effectiveness of its RESP™ Biosensor in children presenting with wheeze.
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Surgery Center is First in Southern California to Adopt New Wireless Technology for Arthroscopy featuring Lazurite
De La Vina Surgicenter in Santa Barbara, CA, and medical device and technology company Lazurite® announced that De La Vina is the first healthcare center in Southern California to adopt Lazurite’s new ArthroFree® Wireless Surgical Camera System.
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GI health platform Vivante Health secures $31M
Digital gastrointestinal health company Vivante Health announced it closed a $31 million Series B funding round led by new investor Mercato Partners, bringing its total raise to $47 million.
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Day Zero Diagnostics Announces Completion of $16M Financing Round
Day Zero Diagnostics Inc. (DZD), an infectious disease diagnostics company harnessing the power of whole-genome sequencing and AI to combat the rise of antibiotic-resistant infections, announced today the recent completion of a $16M round of financing.
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Tasso Receives CE Mark Certification for Tasso+™, Latest Generation Whole Blood Collection Lancet Device
Tasso, Inc., the leading provider of patient-centric clinical-grade blood collection solutions, today announced it received CE Mark certification for its Tasso+™ device, a convenient, virtually pain-free blood lancet that collects whole liquid blood samples.
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InBrain Neuroelectronics wins FDA breakthrough nod for intelligent network modulation system
InBrain Neuroelectronics announced today that it received FDA breakthrough device designation for its intelligent network modulation system.
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CardiaCare Completes Seed Extension Raise to Support Clinical Pilot Studies
CardiaCare, a medical device company developing a breakthrough wearable technology for detecting, monitoring, and non-invasively treating cardiac arrhythmias using drug-free neuromodulation, recently closed an over-subscribed Seed Extension round.
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Conavi Medical Announces Close of Financing to Bolster Novel Intravascular Imaging Technology
Conavi Medical, Inc. (www.conavi.com), a leader in hybrid intravascular imaging, is pleased to announce the close of $12.5 mil USD of funding, including participation from existing investors.
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FDA Approves Blood Flow-Diverting LimFlow System for No-Option CLTI
The US Food and Drug Administration has approved the LimFlow self-expanding covered stent system for arterialization of deep veins in the foot in no-option patients with chronic limb-threatening ischemia (CLTI) who are facing major amputation, its manufacturer announced today.
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Sparta Biomedical Closes an Oversubscribed Convertible Round to Advance its Breakthrough Device
Sparta Biomedical Inc., a privately held medical technology company, revolutionizing osteoarthritis treatment, is pleased to announce the close of a heavily oversubscribed convertible funding round.
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Morgantown-based Intermed Labs leverages AI and 3D printing to make prosthetics accessible featuring Fingy3D
Retired coal miner Mark Lance was working with his son at his farm, cutting branches that were overhanging the house. Lance was the ground man holding the rope while his son cut the branches.
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Sparta Biomedical’s Breakthrough Device, Ormi, to be Featured at the 17th ICRS World Congress on September 10, 2023
Sparta Biomedical, a privately held medical device company specializing in partial knee resurfacing, is excited to announce Dr. Adam Yanke’s presentation at the 2023 ICRS World Congress in Barcelona, Spain.
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Gradient Denervation Technologies closes €14m Series A led by Sabadell Asabys
Gradient Denervation Technologies (“Gradient”), a medical device company developing an innovative catheter-based solution for the treatment of pulmonary hypertension, announces today the successful closing of a €14m Series A financing that will support ongoing clinical development and evaluation of the ultrasound-based catheter device.
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VeinWay Closes Oversubscribed SAFE Round and Begins Series A Round
Vascular Surgeons Stephen Black, MD, and Houman Jalaie, MD, PhD join VeinWay’s Scientific Advisory Board.
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Admetsys’ FDA Breakthrough Designation Accelerates Arrival of Fully Autonomous Clinical Robotics in Hospital
Admetsys Corporation, a biomedical technology company specializing in critical care automation, announced today that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.
Vitestro starts largest-scale clinical trial globally for its autonomous blood drawing device, with enrolment of first patients in A.D.O.P.T.
Vitestro, expert in medical robotics, has launched the A.D.O.P.T. Trial for its autonomous blood drawing device (image). With an anticipated sample size of over 10,000 patients, this is the most significant study globally to date of autonomous blood collection. Vitestro expects to obtain CE marking by the end of 2024.
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Abbott to Acquire Bigfoot Biomedical, Furthering Efforts to Develop Personalized, Connected Solutions for People with Diabetes
Abbott (NYSE: ABT) and Bigfoot Biomedical today announced a definitive agreement for Abbott to acquire Bigfoot, a leader in developing smart insulin management systems for people with diabetes.
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CardieX Sets U.S. IPO at 1.33 Million ADSs Priced at $7.50-$8 Each
Australian medical-device maker CardieX on Wednesday said it plans to sell more than 1.33 million American depositary shares at between $7.50 and $8 apiece in its U.S. initial public offering.
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PolyVascular, CobiCure partner on non-surgical pediatric heart valve
CobiCure Medical Technologies announced that it provided $2 million in funding to PolyVascular to advance a pediatric heart valve.
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Sparta Biomedical Celebrates Prestigious Recognition in MedTech and Significant Milestone
Sparta Biomedical Inc, a pioneering medical technology company specializing in redefining osteoarthritis treatment, proudly reflects on a momentous period marked by significant recognition and notable achievements.
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Zetagen Therapeutics Secures 9.79 Million USD Series B Funding Raise for Advancement of ZetaMet™ and ZetaMAST™ for Treatment of Metastatic Bone and Soft Tissue Lesions
Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company focused on driving breakthrough innovation in the treatment of metastatic cancers to bone and soft tissue organs as well as osteologic interventions, today announced the close of $9.79 million USD Series B funding round.
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RevBio Receives FDA Approval to Conduct its Second U.S.-Based Clinical Trial for Dental Implant Stabilization
RevBio, Inc., announced that it has received approval from the U.S. Food and Drug Administration to start a 20-patient clinical trial to examine the safety and efficacy of a more rapidly replaced, pH modified porous formulation of the company’s bone adhesive biomaterial called Tetranite® to immediately stabilize dental implants following tooth extractions.
Astellas and Eko Health Announce Agreement to Incorporate Next Generation Eko CORE 500™ Digital Stethoscope into Z1608, an Innovative Solution Under Development for Heart Failure Patients Built on Welldoc’s Proven Digital Therapeutic Platform
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Eko Health Inc. (Co-Founder and CEO: Connor Landgraf, “Eko”) announced today that they have entered into a License & Supply Agreement for the global supply and license of Eko’s latest digital stethoscope, the CORE 500™, and a custom suite of Eko’s AI-powered cardiovascular disease detection software.
Major $148 million boost for 40 job-creating diversification projects featuring OncoRes Medical
The Cook Government is charging ahead with its plan to diversify Western Australia’s economy, with a massive $148 million funding injection to 40 innovative, job-creating projects across the State through its signature Investment Attraction Fund.
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NIH Awards Prenosis With Two Grants Totaling $4.8 million to Enable Precision Medicine for Sepsis
Prenosis, Inc., an artificial intelligence company enabling precision medicine in acute care, announced today that it has been awarded two Phase 2 SBIR grants totaling $4.8M in funding by the National Institute of General Medical Sciences (NIGMS), a division of the National Institute of Health (NIH).
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Current Surgical Receives $400k Grant from NIH’s National Cancer Institute to Develop Surgery Platform for Early-Stage Cancer
Current Surgical Inc., a medical technology company developing a new surgical platform to improve the safety and efficacy of cancer surgery, today announced that it has received a $400,000 grant from the National Institutes of Health (NIH) to support the development of its technology.
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Eclipse Regenesis Reaches First-in-Human Milestone with Treatment for Short Bowel Syndrome
Twenty-four years ago, then pediatric surgery fellow James Dunn, MD, PhD had an idea for a way to help children with short bowel syndrome (SBS), a devastating condition that makes normal eating impossible because there isn’t enough functional small intestine to absorb adequate nutrition.
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Biocomposites invests in Renovos Biologics – developers of the RENOVITE® nanoclay therapeutic delivery platform
Investment will help fund pre-market approval for use in spine, trauma and orthopaedics
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Liberate Medical Raises $6.2M in Series B Financing
Liberate Medical, a Crestwood, KY-based company which specializes in in the development of novel non-invasive neurostimulation devices, raised $6.2M in Series B funding.
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Augmedics snaps up $82.5M to advance spinal surgery using AR and AI
Spinal is one of the fastest-growing categories of surgery, with the number of operations taking place annually now approaching 8 million. But their frequency belies the complexity and sometimes less-than-perfect outcomes of these procedures.
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StrokeDx Named 2023 Vision Award Winner at WSGR Medical Device Digital Health Conference
Neuroimaging stroke diagnostic startup takes top award from among five finalists
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Telix to acquire Lightpoint Medical and its radio-guided surgery business
Australia-based Telix Pharmaceuticals has signed an agreement to acquire UK-based Lightpoint Medical along with its SENSEI radio-guided surgery business.
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Lenox Hill first in NYS to use virtual reality platform for complex mandibular surgery
Northwell Lenox Hill Hospital is the first hospital in New York State to use ImmersiveTouch’s state-of-the-art surgical planning technology, which creates virtual and augmented reality 3D models of patients’ anatomy for enhanced visualization, custom surgical solutions, and improved patient communication.
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Anumana Receives U.S. FDA Breakthrough Device Designation for its Cardiac Amyloidosis Algorithm
Anumana, Inc., a leading AI-driven health technology company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its ECG-AI algorithm designed to aid the early identification of cardiac amyloidosis, a life-threatening, rare, underdiagnosed cause of heart failure.
LEADOPTIK Receives Investment from Applied Ventures
New investment adds to recent $5 million venture funding to speed development of lung cancer detection product using advanced metasurface technology
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CorWave Raises €26M in Second Closing of Series C Funding
CorWave, a Clichy, France-based company developing cardiac assist devices, raised €26M in second closing of Series C funding.
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Merit Acquires Bluegrass Vascular’s Surfacer Inside-Out Access Catheter System
Merit Medical Systems, Inc. recently announced the acquisition of the Surfacer Inside-Out access catheter system from Bluegrass Vascular Technologies, Inc.
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4 Houston startups selected for preeminent medtech accelerator
our Houston startups have been selected for the 2023 cohort of the MedTech Innovator’s four-month accelerator program.
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MedTech Innovator chooses 3 Minnesota startups for global accelerator
Three Minnesota-based medical startups were chosen among the 61 global companies selected for MedTech Innovator’s four-month accelerator program, which will get started at a summit in Mountain View, California Wednesday.
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Four Irish start-ups bag spots in MedTech Innovator 2023
Galway-based Mirai and Plio as well as Dublin’s Pumpinheart and Xtremedy will accelerate with the MedTech Innovator starting next week.
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Nutromics bags $7M in pre-Series A funding
Diagnostics company Nutromics has raised A$11 million ($7 million) ahead of its Series A funding round later this year.
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Prenosis Inc. Receives BARDA Contract to Study Utility of Its Sepsis Diagnostic Tool
Prenosis Inc., an artificial intelligence company enabling precision medicine in acute care, announced today it has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA), a component of the Administration for Strategic Preparedness and Response (ASPR), within the U.S.
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RevBio is Awarded a $2 Million Grant to Advance the Development of its Novel Dental Adhesive Bone Scaffold Product
RevBio, Inc., announced that it has been awarded a $2 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Dental and Craniofacial Research (NIDCR), part of the National Institutes of Health (NIH).
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Candesant Biomedical Announces $35M in Series B Financing to Advance Commercialization of Brella™, the First and Only FDA-cleared 3-Minute SweatControl Patch™
Candesant Biomedical, Inc. (“Candesant”), a private medical device company focused on the development and commercialization of non-invasive treatments for hyperhidrosis or excessive sweating, today announced the closing of a Series B financing, raising a total of $35 million to advance the commercialization of Brella, the first-and-only FDA-cleared 3-Minute SweatControl Patch.
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Xtremedy Medical: Zapping wound infections to accelerate healing
Founded in 2020, Galway-based Xtremedy is raising seed funding to start clinical trials for its novel medical device to treat diabetic foot infections.
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NeuroFlow, Atlantic Health System partner to launch collaborative care model
Pennsylvania-based NeuroFlow, a behavioral health company, has partnered with New Jersey-based Atlantic Health System to advance a collaborative care model for adult behavioral health patients at 16 accountable care organization (ACO) sites.
LEADOPTIK Raises $5 Million in Series Seed Funding to Advance Early Lung Cancer Detection with Cutting-Edge Imaging Technology
LEADOPTIK Inc., a Silicon Valley-based medical imaging company today announced that it has raised $5 million in an oversubscribed series seed funding, led by MetaVC Partners with participation from SOSV, Sony Innovation Fund, TSVC, ENEA, Arash Ferdowsi (co-founder of Dropbox), Ray Muzyka (co-founder of BioWare), and others.
Moon Surgical Appoints Fred Moll, MD, as Board Chair and Raises Additional $55.4 Million in New Funding with Leading Investors Sofinnova Partners and NVIDIA
Moon Surgical, a French-American pioneer in collaborative robotics, announced today that it has secured $55.4 million in additional funding to support the continued development and planned commercialization of its Maestro System.
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CORRECTING and REPLACING Universal DX Presents Data from Large, 1,000-patient, Multi-Cohort Study Proving 93% Sensitivity for Colorectal Cancer and 54% Sensitivity for Advanced Adenoma at 92% Specificity
Universal Diagnostics (Universal DX), a bioinformatics and multi-omics company on a mission to transform cancer into a curable disease, today announced the results of a large international multi-cohort case-control study, which demonstrate that cell-free DNA methylation and fragmentation signals combined with machine-learning can be used to detect early-stage colorectal cancer (CRC) with 93% and pre-cancerous advanced adenomas (AA) with 54% sensitivity at 92% specificity.
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Gaylord Specialty Healthcare First in Nation to Adopt Ground-Breaking Pharyngeal Electrical Stimulation Technology to Treat Patients with Dysphagia featuring Phagenesis
Gaylord Specialty Healthcare, a nonprofit rehabilitation-focused healthcare system, is proud to announce that it is the first healthcare organization in the nation to use the Phagenyx® Neurostimulation System from Phagenesis, Ltd. to treat dysphagia among stroke patients.
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CardiaCare Names Ken Nelson Chairman of its Board of Directors
CardiaCare, a clinical stage digital therapeutic company developing the world’s first non-invasive, neuromodulation wearable for atrial fibrillation treatment, announced today that Ken Nelson has been appointed Chairman of the Board.
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Tricog Raises $8.5 Million In Series B2 Funding
Heart health AI firm Tricog has raised $8.5 million in a Series B2 funding round from OMRON HEALTHCARE, Japan and Sony Innovation Fund, Japan. Existing investors UTEC – The University of Tokyo Edge Capital, Japan, Inventus Partners LLP and SG Innovate, Singapore, participated in this round.
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Distalmotion raises $150M to accelerate FDA approval and clinical experience
Distalmotion announced today the first closing of its USD 150 million financing. This significant fundraise reinforces the confidence of its existing investors led by Revival Healthcare Capital.
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Xenocor Completes Oversubscribed $10 million Series A to Lead the Future of Laparoscopic Visualization
Led by GenHenn Venture Fund I, Xenocor will leverage the capital to facilitate launch and rapid adoption of the 5mm articulating Saberscope
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Candesant Biomedical Receives FDA Clearance of Brella™1, the First and Only 3-Minute SweatControl Patch™, to Significantly Reduce Primary Axillary Hyperhidrosis (Excessive Underarm Sweating)
New Non-Invasive Treatment Significantly Reduces Excessive Underarm Sweating and Significantly Improves Quality of Life – Including Reducing the Negative Impact of Excessive Sweating on Daily Activities – After a Single In-Office TreatmentFDA Clearance Based on Data from Randomized, Double-Blind, Multicenter Pivotal SAHARA Study Demonstrating Brella is Effective and Well ToleratedBrella-Treated Participants Maintained Sweat Reduction for Three Months and Longer in Some
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Genetesis Receives 2nd FDA Breakthrough Device Designation for Non-Invasive Diagnosis of Myocardial Ischemia Using CardioFlux MCG
Designation represents progress for patients with suspected Coronary Microvascular Dysfunction as the FDA recognizes disease’s debilitating impacts and the lack of effective non-invasive options for efficient diagnosis
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MY01, Inc. Receives $12.5M Funding to Accelerate Growth
MY01, Inc., a medical technology company that uses microsensors to aid physicians in diagnosing compartment syndrome, today announced it has raised a $12.5 million USD Series A funding round.
EvoEndo CEO to leave, replacement named
EvoEndo announced today announced a new CEO and COO along with the departure of previous CEO Heather Underwood.
Prapela receives NIH Grant to improve the treatment of Apnea of Prematurity in collaboration with Tufts Medical Center and the University of Alabama at Birmingham
Prapela, Inc., an infant health company in Biddeford, ME, was awarded a grant through the National Institutes of Health (NIH) Blueprint MedTech program and National Institute on Drug Abuse (NIDA), to support the development and evaluation of Prapela’s pad to treat apnea in preterm newborns in collaboration with neonatologists at Tufts Medical Center and the University of Alabama at Birmingham.
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Portable X-ray vision is one step closer to reality with OXOS Medical
The global medical imaging market was valued at a touch over $28 billion in 2021, and is only expected to rise with an increase in demand for early-detection services as well as lifestyle and age-related conditions.
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Northgate® Technologies Inc Announces Acquisition of Allotrope Medical™ Inc.
Northgate Technologies, Inc. (NTI) announced today that it has successfully completed the acquisition of Allotrope Medical™ Inc, a US-based medical device manufacturer that develops an electrosurgical ureter identification system.
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Gravitas Medical Announces US FDA Clearance of the Entarik Platform
Gravitas Medical today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its innovative Entarik Feeding Tube System and Feeding Tube.
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GT Medical Technologies Raises $45 Million in Oversubscribed Series C Financing Led by Gilde Healthcare
GT Medical Technologies, Inc., a medical device company dedicated to improving the lives of patients with brain tumors, announced that it has raised $45 million in a Series C financing led by Gilde Healthcare Partners with participation from existing institutional investors MVM Partners, MedTech Venture Partners, and BlueStone Venture Partners.
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FDA Issues Clearance for Woven Orthopedic’s Simple Solution to Massive, Unspoken Challenge in Orthopedic Spine Surgery
Woven Orthopedic Technologies, developer of an implantable sleeve to aid screw fixation in challenging scenarios, announced today that its Ogmend® Implant Enhancement System has received 510(k) clearance from the Food and Drug Administration (FDA) for use in spine surgery.
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MindMics Joins Qualcomm Voice and Music Extension Program to Bring Next Generation of Health Monitoring Enabled Through Earbuds
MindMics, the inventor of sound-based technology™ for in-ear earphones and hearables, today announced that it has joined the Qualcomm® Voice and Music Extension Program.
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Caira Surgical Unveils Caira TKA Radar Navigation System During CG 2023 Musculoskeletal Conference
Caira Surgical, the pioneer in radar surgical tracking for navigated and robotic joint replacement surgery, unveiled today its revolutionary new technology for advanced joint replacement, the Caira TKA Radar Navigation System, during the CG 2023 Musculoskeletal Conference presentation by Caira’s Chief Executive Officer Jon Greenwald.
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Where Is the Innovation in Sterilization? (featuring Phiex Technologies)
There are many ways to wage wholesale death and destruction upon the microscopic world. Chemical, thermal, radiation, and other energy-based means abound.
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Puzzle Medical Closes CAN$ 34 million Series A Funding Round to Complete Human Feasibility Study Led by Cordis-X
Puzzle Medical, a Montreal-based startup developing a percutaneous heart pump designed to support cardiac and renal function in patients with advanced heart failure, announced today the successful closing of its CAN$ 34 million Series A funding round led by Cordis-X, a Cardiovascular-Focused Investment Vehicle Backed by Ajax Health, Hellman &Friedman, and KKR.
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FDA authorizes marketing of Medasense’s NOL® (nociception level index) technology through a De Novo grant
Medasense Biometrics Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted marketing authorization to the PMD-200 patient monitor with NOL® technology developed for monitoring nociception (the physiological response to pain) through the De Novo premarket review pathway.
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Current Surgical is developing a ‘smart’ needle designed to treat cancerous tumors
D.C.-based Current Surgical this week announced a $3.2 million seed. The round, which brings the firm’s total raise up to $4 million, was led by True Ventures and features 1517 Fund and SciFounders.
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Rhaeos Raises $10.5M in Series A Funding to Launch Novel Hydrocephalus Shunt Monitor and Accelerate Pipeline Product Development
FlowSense shunt monitor quickly and non-invasively detects the flow of cerebrospinal fluid in implanted shunts, addressing a significant unmet need in hydrocephalus patient management
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VA names NeuroFlow a winner in $20 million Mission Daybreak grand challenge to reduce Veteran suicides
The U.S. Department of Veterans Affairs has named NeuroFlow as a winner in Mission Daybreak — a $20 million challenge designed to help the VA develop new suicide prevention strategies for Veterans. As a winner, NeuroFlow will receive $500,000.
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Macmillan invests in Neutrocheck device for home-testing neutropenic sepsis
This could save time and reduce stress for cancer patients as well as reduce pressure on the NHS.
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National Kidney Foundation Innovation Fund Announces Investment in Relavo
The National Kidney Foundation (NKF) today announced the latest investment from its Innovation Fund, the philanthropic impact investment program of NKF.
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RevBio Receives a Strategic Investment from Pacific Dental Services to Support Ongoing Clinical Trials in Implant Dentistry
RevBio, Inc. announced that it has received a strategic investment from Pacific Dental Services® (PDS) to support the clinical development of its bone adhesive biomaterial for implant dentistry.
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Cork medtech company acquired by German firm featuring AventaMed
Cork-based medical technologies company, AventaMed has been acquired by German firm, Karl Storz for an undisclosed amount.
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Laborie Expands NICU footprint with Acquisition of Novonate
Leading diagnostic and therapeutic medical technology company, Laborie Medical Technologies Corp. (Laborie), announced that it has acquired Novonate, Inc.
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Insulet pays Bigfoot Biomedical $25M for pump-based automated insulin delivery technology
Bigfoot acquired the pump technology through its 2015 takeover of Asante Solutions, the manufacturer of the 510(k)-cleared Snap insulin pump. At the time, Bigfoot predicted the acquisition would accelerate the development of its system for managing Type 1 diabetes.
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29 cutting-edge medtech innovations recognized with Edison Awards featuring Endiatx and DermaSensor
More than two dozen medical technology developers are winners of the 2023 Edison Awards.
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Harvard spin-off CELLVIE raises $5.5M of additional funding to accelerate the development of Therapeutic Mitochondria Transplantation as a new treatment modality
Cellvie Inc., a leader in Therapeutic Mitochondria Transplantation (TMT), an approach developed at Harvard, closes a $5.5 Million financing to get Series A-ready by the end of 2023.
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Aluna Raises $15.3M in Series B Funding To Empower Asthma, COPD and Cystic Fibrosis Patients and Their Doctors
Aluna, the award-winning lung health management platform, today announced it has completed a $15.3 million Series B round of financing to continue growing its solution among doctors and patients managing asthma, cystic fibrosis and COPD.
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Alleviant Medical Closes $75M in Financing; Receives FDA IDE Approval for Pivotal Clinical Trial
Alleviant Medical, Inc., a privately-held medical device company developing a no-implant interatrial shunt for heart failure, today announced the closing of a $75 million equity financing co-led by S3 Ventures and RiverVest Venture Partners.
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First Impressions are Crucial in Medtech, Interview with Retia Medical CEO Marc Zemel
The medtech industry is a cause close to Marc Zemel’s heart. After getting a master’s degree in mechanical engineering from MIT and an MBA from Yale, Marc decided that he wanted to use his education to make a real difference in the world.
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Strados Labs Forms Collaboration with Boehringer Ingelheim for its Idiopathic Pulmonary Fibrosis (IPF) Pilot Study
Starting in early 2023 the biopharmaceutical company will use the Strados RESP™ Biosensor to remotely monitor cough and crackles in patients at home
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Going wireless in the hospital operating room; Cleveland-area startup Lazurite wins FDA OK for new camera to replace wired technology
We’re living in a wireless world. So why, Eugene Malinskiy wondered, were surgeons still dealing with bulky, heavy wires in the operating room?
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New Data from Universal DX Demonstrates Effective Detection of Early-stage Colorectal Cancer Using Combination of Methylation, Fragmentation and Machine Learning
Universal Diagnostics (Universal DX), a bioinformatics and multi-omics company on a mission to transform cancer into a curable disease, today announced the results of an international, observational cohort study which evaluated the effectiveness of utilizing a combination of cell-free DNA (cfDNA) methylation, fragmentation and machine learning to detect early-stage colorectal cancer (CRC).
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Synergia Medical Increases Series B Funding to €12.8 Million with an Additional €3.8 Million
Synergia Medical, a preclinical medical device company that has developed NAO.VNS (Vagus Nerve Stimulation), the first non-metal optoelectronic neurostimulator for the treatment of drug-resistant epilepsy, today announced the successful completion of an additional €3.8 million of Series B funding bringing the total to €12.8 million.
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CARI Health Raises $2.3M in Seed Round to Advance Remote Medication Monitoring
Digital health startup CARI Health has closed an oversubscribed $2.3 million seed round that will help it bring the world’s first wearable real-time medication monitor to market.
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Pristine Surgical’s Summit arthroscope secures FDA 510(k) clearance
edical technology manufacturer Pristine Surgical has secured 510(k) clearance for its Summit 4K single-use surgical arthroscope from the US Food and Drug Administration (FDA).
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AVS (formerly known as Calcium Solutions) Raises $20 Million in Series B Round to Advance Pulsatile Intravascular Lithotripsy (PIVL) Solutions
AVS, an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease with its PIVL™ therapy, announced today that it raised $20 million in Series B financing.
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Prapela Receives FDA’s Breakthrough Device Designation to Investigate the Use of Stimulation to Treat Apnea of Prematurity
Prapela, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to explore the use of its proprietary stimulation to treat apnea of prematurity (AOP), a cessation of breathing for 20 seconds or longer and a major morbidity of preterm infants.
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Zimmer Biomet to Acquire Embody, Inc.
Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced that it has reached a definitive agreement to acquire Embody, Inc., a privately-held medical device company focused on soft tissue healing, for $155 million at closing and up to an additional $120 million subject to achieving future regulatory and commercial milestones over a three year period.
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Mayo Clinic takes a stake in PillBot developer Endiatx
Mayo Clinic and Endiatx have signed a know-how license agreement covering the ongoing development of Endiatx’s PillBot.The deal gives Mayo Clinic an equity stake in the robotic stomach camera startup, Endiatx co-founder and CEO Torrey Smith told MassDevice.
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Garwood Medical Devices, LLC named as an Awardee in the Innovations for Vets QuickFire Challenge Innovation
December 16, 2022, Garwood Medical Devices, LLC has been selected as an awardee of the Innovations for Vets Quickfire Challenge launched by Johnson & Johnson Innovation – JLABS with the Johnson & Johnson Office of Military and Veterans Affairs.
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Anumana and Pfizer Partner to Enable Early Detection of Underdiagnosed Cardiovascular Disease
Anumana, Inc., an AI-driven health technology company and portfolio company of nference, has entered into a multi-year agreement with Pfizer, Inc. for Anumana to develop an artificial intelligence electrocardiogram algorithm (AI-ECG) designed to enable the early suspicion of cardiac amyloidosis.
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CardiaCare Announces Licensing and Distribution Agreement to Commercialize its Digital Neuromodulation Wearable for Non-invasive Atrial Fibrillation Treatment
CardiaCare, a clinical stage digital therapeutic company developing the world’s first non-invasive, personalized neuromodulation wearable for atrial fibrillation treatment, announced today the execution of a strategic licensing agreement with Dr.
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Confronting EtO sterilization with Phiex Technologies CEO CL Tian
EPA shutdowns and a mammoth plaintiff settlement against Ethylene Oxide (EtO) created a logistical nightmare for the medical device industry. Phiex Technologies co-founder & CEO CL Tian and her team are on a mission to change all that.
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AuriGen Medical crowdfunds nearly €3m in three weeks
AuriGen Medical, an Irish medical devices start-up has raised almost €3 million through crowdfunding in just three weeks.
Cardiosense, Inc., Completes $15.1 Million Series A Financing to Advance Artificial Intelligence Platform for Heart Disease
Cardiosense, Inc., a Chicago-based digital health company leveraging artificial intelligence and multi-sensor devices to enable early detection of cardiovascular disease, announced today that it has raised $15.1 million in Series A funding, co-led by Broadview Ventures and Hatteras Venture Partners, with participation from Laerdal Million Lives Fund, OSF Ventures, UnityPoint Health Ventures, and Portal Innovations.
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Money Moves: iECURE, Avisi Technologies and Invent Analytics just scored $75M+ in venture capital
Avisi Technologies raised a seed roundMedtech startup Avisi Technologies has raised a seed round, CEO Rui Jing Jiang confirmed to Technical.ly. The company — a 2020 RealLIST Startups honoree — aims to treat open-angle glaucoma with an ocular implant that’s designed to remove excess fluid from inside the eye.
First AI-Powered Precision Oncology Platform for Prostate Cancer Care, iQuest™, Receives FDA Clearance (featuring Avenda Health)
Avenda Health, an AI healthcare company creating the future of personalized prostate cancer care, today announced its cancer management platform, iQuestTM, has received 510(k) clearance by the U.S. Food and Drug Administration (FDA).
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Lazurite is Recognized in the 2022 Medical Device Network Excellence Awards & Rankings for its ArthroFree™ System
Medical device and technology company Lazurite has received recognition from Medical Device Network Excellence Awards & Rankings, one of the largest, most prestigious, and widely recognized programs in the industry.
Moon Surgical wins first FDA 510(k) clearance for surgical robot
Moon Surgical announced today that it received FDA 510(k) clearance for its Maestro surgical robotics system.
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Lazurite™ and Hospital for Special Surgery Announce a Collaboration Agreement Focused on Lazurite’s ArthroFree™ Wireless Surgical Camera System
Medical device and technology company Lazurite and Hospital for Special Surgery (HSS), the world’s leading academic medical center focused on musculoskeletal health, today announced a new collaborative relationship based on Lazurite’s ArthroFree™ Wireless Surgical Camera System, the first wireless surgical camera system to receive market clearance from the U.S.
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Kheiron Medical Technologies and Microsoft Join Forces To Support Breast Cancer Detection
Kheiron Medical Technologies announced a new technology collaboration with Microsoft that is already supporting the detection of breast cancers alongside radiologists.
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Dublin medtech Novus Diagnostics raises €5m for its rapid sepsis test
Irish medtech Novus Diagnostics has secured €5m in equity financing to further develop its rapid detection sepsis test.
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New View Surgical, Inc. Closes $12.1M Series B-1 Financing, Readies Limited Market Release of its VisionPort™ System For Minimally Invasive Surgery
New View Surgical, Inc., an emerging medical device company developing proprietary imaging and access technologies for minimally invasive surgery (MIS), today announced the closure of a $12.1M Series B-1 equity financing round to fund the commercialization of its VisionPort™ System.
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Johnson & Johnson Innovation Names Awardees in the Innovations for Vets QuickFire Challenge: Lung Cancer & Physical Trauma
Johnson & Johnson Innovation, together with Johnson & Johnson Office of Military and Veterans Affairs, announced that AmacaThera, Hawkeye Bio, Inc., Garwood Medical Devices, LLC, Immunophotonics, Limax Biosciences, and Nanochon have been selected as the awardees in the Innovations for Vets QuickFire Challenge: Lung Cancer & Physical Trauma.
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Neocis Secures $40M in Additional Funding to Continue Transforming Dental Surgery With Robotics
Neocis®, manufacturer of Yomi® and the global leader in robot-assisted dental implant surgery, announced today that the company has completed its latest round of financing.
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AdvaMed 2022: Phiex Technologies Takes Medtech Innovator Top Honors; A Look At All Finalists
Phiex Technologies Inc. won the audience vote for the grand prize of $350,000 and MedTech Innovator Award 2022 at the AdvaMed MedTech Conference in Boston, beating out finalists Moon Surgical, Limax Biosciences, LiveMetric and 52 North Health, which received $25,000 each.
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NeuroFlow nets $25M in growth capital, new Air Force partnership
NeuroFlow, a behavioral health startup, has clinched $25 million in growth capital.
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Bay Area Business Accelerator Candidates
$35,000 grantTero-Pekka Alastalo | CardioSignalTero-Pekka Alastalo, MD, PhD, is the president and chief medical officer of CardioSignal, a San Francisco area company that’s developed novel digital biomarkers for heart diseases.
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Genetesis Announces Close of $17.5 Million Series C Financing
Genetesis, the market leader in next-generation biomagnetic imaging, has announced that it has closed $17.5 million in Series C Financing. The round was led by Mithril Capital with participation from Cercano Management as well as from existing investors, including JobsOhio Growth Capital, Ohio Innovation Fund and CincyTech.
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Arterys and Tempus’ Precision Merger
Arterys was just acquired by precision medicine AI powerhouse Tempus Labs, marking perhaps the biggest acquisition in the history of imaging AI, and highlighting the segment’s continued shift beyond traditional radiology use cases.
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Starlight Cardiovascular Secures $9.48M in Series A Financing to Advance Pediatric Health
Starlight Cardiovascular announced today that it has closed the first $9.48M in an $11.45M Series A financing, which will be used to progress development of its portfolio of pediatric interventional cardiology devices. The financing is led by Bird B and included conversion of previously-issued notes.
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Koya Medical Announces Two Clinical Data Publications for Dayspring® Active Compression Treatments for Lymphedema and Venous Disease
Koya Medical, a healthcare company on a mission to transform lymphatic and venous care through a comprehensive suite of innovative, people-centric platforms, today announced two clinical data publications for the treatment of lymphedema and venous disease with its Dayspring® active compression system, including results from the multi-center, randomized, crossover head-to-head trial (NILE) published in the Journal of Vascular Surgery.
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FDA Clears World’s First Single-use 5mm Laparoscope with Auto-Focus
Xenocor, a Utah-based medical device company, today announced that the FDA cleared the enhanced version of their Saberscope, the world’s first true HD, fog free, articulating, single-use laparoscope.
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Puzzle Medical Devices Inc. Wins TCT 2022 Shark Tank Innovation Competition
The Cardiovascular Research Foundation (CRF) is pleased to announce that Puzzle Medical Devices Inc. has won the TCT 2022 Shark Tank Innovation Competition for its novel circulatory support device that is implanted percutaneously in the abdominal aorta.
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Former NASA Astrophysicist Creates MindMics Earbud Biometric Technology To Reduce Stress
Stress is part of almost everyone’s daily lives. Studies show that it not only affects a person’s mental health, it also takes a physical toll on the body, releasing inflammatory hormones that can increase cardiovascular and cancer risk, among other issues. It has economic consequences as well.
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Embody, Inc. Announces $10.4 Million Series C Funding Round
Funds to Support Commercial Expansion and Post-Market Clinical Studies of Tapestry® for tendon and ligament injuries.
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NYU Langone Health Orthopedic Surgeon Performs First Surgery Using New Wireless Surgical Camera
NYU Langone Health today announced the completion of the first orthopedic surgery in the United States using a completely wireless camera system. Orthopedic surgeon Laith M.
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Sentec and PyrAmes form partnership to bring noninvasive care to critically ill infants
Sentec and PyrAmes have established a commercial partnership to bring Boppli, PyrAmes’ first-of-its-kind continuous noninvasive blood pressure device, to neonatal intensive care teams throughout the United States.
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New Findings from Universal DX: Through a Simple Blood Test, Our Body’s Gut Bacteria Can Help Detect Early-Stage Colorectal Cancer
Universal Diagnostics (Universal DX), a bioinformatics and multi-omics company on a mission to transform cancer into a curable disease, today announced the results of a proof of principle study demonstrating that the analysis of microbiome signatures in plasma can assist in early detection of colorectal cancer (CRC).
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Synergia Medical Successfully Raises Series B Funding of €9 Million
Drug Resistant Epilepsy TreatmentSYNERGIA MEDICAL SUCCESSFULLY RAISES SERIES B FUNDING OF €9 MILLIONThis financing assures the First-In-Human implantation of the NAO.VNS in 2023
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Lab-on-a-patch maker Nutromics scores $14M from Dexcom Ventures, others
Medtech startup Nutromics has received a $14 million investment from strategic investors, including Dexcom Ventures, VU Venture Partners, and Artesian Investments.
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Otolith Labs Announces $20 Million Series A Financing by Morningside Ventures
Otolith Labs, a medical technology company developing noninvasive wearable medical devices for the treatment of vestibular disorders, today announced the closing of a $20 million Series A financing round by Morningside Ventures.
Neurofenix puts a new spin on home stroke rehabilitation with the NeuroBall
Millions around the world suffer strokes every year, and millions more are in recovery from one they’ve suffered. Regaining the use of affected limbs and capabilities is a long road, but one that can be shortened by intensive rehabilitation efforts — which Neurofenix has shown can take place in the home rather than during frequent trips to the hospital.
Avenda Health Raises $10M in Series B, Innovating Detection and Treatment for Prostate Cancer Care
Avenda Health, an AI healthcare company creating the future of personalized prostate cancer care, today announced it has raised $10M in Series B funding led by VCapital.
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Sibel Health raises $33M to scale wearable sensors for remote monitoring in the hospital
Bio-integrated sensor developer Sibel Health announced today that it closed a $33 million Series B financing round.
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NIH announces prize winners of maternal health diagnostics challenge (featuring Raydiant Oximetry)
Newswise — The National Institutes of Health today announced the winners of its NIH Technology Accelerator Challenge (NTAC) for Maternal Health, a prize competition for developers of diagnostic technologies to help improve maternal health around the world.
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Retia Medical Raises $15M in Funding
Retia Medical, a Valhalla, NY-based innovator in advanced hemodynamic monitoring, secured $15m in Series B funding.
FDA clears Onkos Surgical’s 3D-printed pelvic reconstruction implants
The field of medicine has moved into a new dimension in recent years as 3D printing technology has become more accurate and been adapted to work with biocompatible and biological materials that can be shaped into implants, drugs, scar tissue and even replacement organs.
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FDA Accepts & Closes LimiFlex PMA Module (featuring Empirical Spine)
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently had its Premarket Approval (PMA) Module II accepted and closed by the US Food & Drug Administration (FDA), an important milestone in the commercial approval process for its LimiFlex™ Dynamic Sagittal Tether™ (DST).The LimiFlex DST is the first-of-its-kind surgical option for grade 1 degenerative spondylolisthesis (degen spondy) patients with spinal stenosis.
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Medtronic lands option to buy artery disease player CathWorks for up to $585M
Medtronic made a minority investment in CathWorks in 2018, positioning it to monitor the progress of the Israeli startup. The U.S. Food and Drug Administration granted 510(k) clearance to FFRangio late in 2018.
FDA Clears Eko’s Heart Disease Detection Ai For Adults And Pediatrics
Eko, a digital health company advancing heart and lung disease detection, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Eko Murmur Analysis Software (EMAS) for detecting and characterizing murmurs found in adults and pediatric patients.
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This cardiac care startup just landed $20M for virtual rehab services (featuring Moving Analytics)
Moving Analytics (Movn), a virtual at-home intervention program for high-risk cardiac patients, claims to be “the most clinically validated” cardiac rehabilitation program on the market.
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Anumana Announces Issuance of New American Medical Association CPT Category III Codes for Novel ECG AI Analysis of Cardiac Dysfunction
Anumana, Inc., an AI-driven health technology company from nference, Inc., today announced the American Medical Association (AMA) has issued new industry-first Category III Current Procedural Terminology (CPT) codes for novel assistive AI algorithmic electrocardiogram risk assessment for cardiac dysfunction, encompassing Anumana’s pipeline of AI-enhanced ECG-based algorithms currently in development for FDA regulatory clearance.
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Surmodics acquires Vetex Medical to boost thrombectomy portfolio
Medical device and in vitro diagnostics company Surmodics has acquired Ireland-based medical device maker Vetex Medical to extend its thrombectomy portfolio.
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Centerline Biomedical Raises $33 Million in Series B Financing
Centerline Biomedical, Inc. (Centerline), a private medical technology company, announced the closing of a $33 million Series B equity financing led by Cleveland Clinic with participation by GE Healthcare, RIK Enterprises, JobsOhio, Jumpstart Ventures and G2 Group Ventures.
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The European Commission grants €2.5 million to ATRO Medical for the accelerated development of their artificial meniscus
The Dutch startup works on the first anatomical meniscus prostheses for patients with chronic knee pain. Their ground-breaking innovation continues to attract international attention, paving the way towards full-scale healthcare implementation.
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Cordis-X Makes Strategic Investment in Adient Medical
Cordis-X is betting big on a next-generation technology that could provide protection against pulmonary embolisms (PE).
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Bright Uro Launches with $6 Million in Seed Financing and Grant from National Institutes of Health
Bright Uro, a medical device company with a mission to transform care for lower urinary tract symptoms (LUTS) through innovations in urodynamics, announced today the launch of the company with $4 million in seed financing from Academy Investor Network, Fred Moll, and several other prominent angel investors.
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Moon Surgical Raises $31.3 Million to Accelerate Development of Maestro Robotic System
Moon Surgical, a pioneer in collaborative robotics, today announced that it has secured $31.3 million in Series A funding. The financing round was led by GT Healthcare Capital & Partners, with participation by Johnson & Johnson Innovation – JJDC, Inc.
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Most competitive EIC Accelerator cut-off awards major funding round to 74 of Europe’s high potential start-ups (featuring ATRO Medical, InVera Medical – formerly Venari Medical, and Selio Medical)
The European Commission selected 74 innovative companies under the first 2022 EIC Accelerator cut-off. They are set to receive up to €382 million of funding in a combination of grants and investments.
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Dutch Startup Helping Vets Gets J&J Award (featuring ATRO Medical)
ATRO Medical B.V., based in the Netherlands, has been recognized by Johnson & Johnson Innovation as an Awardee in the Veterans Lead QuickFire Challenge.
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Multi-center trial shows promising results for implant-free interatrial shunt device to treat heart failure patients (featuring Alleviant Medical)
Results from early clinical evaluation of the Alleviant System to treat heart failure patients with preserved and reduced ejection fraction (HFpEF and HFrEF) was presented today as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2022 Scientific Sessions.
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Linear Health Sciences Gets FDA Clearance for Its Orchid Safety Release Valve
Linear Health Sciences has received the FDA’s 510(k) clearance and Health Canada approval for its Orchid SRV safety release valve.
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Sidekick and Pfizer launch digital therapeutics solution to tackle Atopic Dermatitis
Iceland-based international digital therapeutics innovator, Sidekick Health, has partnered with Pfizer Inc., one of the world’s premier innovative biopharmaceutical companies.
Australian medical device company secures additional $12.5m to advance its breast cancer imaging system towards clinical trials (featuring OncoRes Medical)
Australian medical device company OncoRes Medical today announces it has secured $12.5m to advance its innovative imaging system, to facilitate real-time tumour assessment to help surgeons more accurately identify and remove cancerous tissue such as breast cancer.
How to Apply an Engineering Mindset to Your Medical Device Startup: Interview with Access Vascular CEO Jim Biggins
It’s easy to see that Jim Biggins, Founder and CEO of Access Vascular, is an entrepreneur at heart. He started business ventures as a teenager and has since strategically steered his career path to strengthen the skills needed to eventually launch his own medical device company in 2015.
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San Diego startup creates first portable “cold cap” to save chemotherapy patients’ hair
For many cancer patients, one of the worst parts of the disease stems from the treatment itself: hair loss from chemotherapy.
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DTx firm Sidekick eyeing new partnerships after $55m round
The Iceland-based digital health company – which has just raised $55 million in second-round funding – has been working with Bayer on an app/medicine combination for patients with peripheral artery disease since 2019, and in the following year cut a deal with Pfizer to take a similar approach to five inflammatory disease.
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Strados Labs Receives FDA 510(k) Clearance for Home Use of its Smart Sensor Platform for Respiratory Health, RESP®
Strados Labs, a medical technology company harnessing the power of smart sensors, machine learning and proprietary algorithms to provide early detection and predictions of worsening respiratory diseases, today announced it has received FDA Class II 510(k) clearance for home use of its first product, RESP®, which make this its second FDA clearance in less than 18 months.
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Ictero Medical Closes $6M Series A Financing
Ictero Medical, Inc., a medical device startup developing a novel cryoablation system to treat high-risk patients with gallstone disease, raised an oversubscribed $6M Series A financing led by MedTex Ventures, S3 Ventures, and an undisclosed strategic investor.
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FDA Clears Caretaker Medical’s Patient Monitor for Continuous Hemodynamic Parameters
Caretaker Medical, a digital health provider of wireless patient monitoring technologies, has received FDA 510(k) clearance for four new continuous hemodynamic parameters, adding cardiac output, stroke volume, heart rate variability, and left ventricular ejection time to its VitalStream non-invasive patient monitoring platform.
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NIDO Surgical Announces the Acquisition of SEPIA Device
NIDO Surgical announced today the acquisition of its innovative epicardial ablation technology, SEPIA (Solution for Epicardial Ablation), by an undisclosed medical device company involved in the electrophysiology space. As part of the transaction, the buyer has agreed to accelerate product development of the device.
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Innara Health and Cardinal Health Join Forces to Advance Neonatal Feeding Development
Innara Health, the industry leader in feeding development for newborns and infants born prematurely is collaborating with Cardinal Health on the redesign of the NTrainer System. The next generation NTrainer will be smaller, more intuitive, and easier to integrate into NICU feeding protocols.
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LimFlow Raises $40 Million (€36 Million) in Series D Financing
LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), today announced it has closed a $40 million (€36 million) oversubscribed Series D financing round.
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Tympany Medical: Human-centred design for medical devices
Galway medtech Tympany Medical is drumming up interest for its innovative endoscope design.
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Early Money: A startup from Apple Health vets that promises personalized fitness and nutrition feedback raised $12M (featuring Cor)
Some veterans of Apple Inc.’s health and fitness efforts think they can help you figure that out. Their new startup, dubbed Cor, offers a device that can help people assess how their individual bodies respond to particular fitness and nutrition regimes.
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Osso VR nets $66 million for surgical training
San Francisco’s Osso VR collected $66 million in Series C funding led by Oak HC/FT, the parties tell Axios exclusively.
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Philips and Nuvo Group Collaborate to Extend Prenatal Care Delivery Starting in Rural Colorado
Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and Nuvo Group, a private company commercializing INVU by Nuvo™, an FDA-cleared, prescription-initiated, remote pregnancy monitoring platform, today announced a collaboration to develop a more inclusive pregnancy care experience from the prenatal stage through labor and delivery.
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symplr Purchases GreenLight Medical, Leading Provider of Healthcare Supply Chain Management Software
Symplr®, the leader in enterprise healthcare operations, backed by Clearlake Capital Group, L.P. (together with its affiliates, “Clearlake”) and Charlesbank Capital Partners (together with its affiliates, “Charlesbank”), today announced that it has entered into an agreement to purchase GreenLight Medical, Inc.
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Vivante Health Raises $16M in Series A Round Led by 7wireVentures; Adds Multiple Fortune 500 Clients
Vivante Health, the leading digital solution for digestive health and disease, has announced a $16 million Series A funding round led by 7wireVentures.
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Bluegrass Vascular Closes $5M in Convertible Debt Financing
Bluegrass Vascular Technologies has closed $5 million in convertible debt financing for its innovation, the Surfacer Inside-Out Access Catheter System. Convertible debt notes enable a startup without a valuation to raise capital quickly and less expensively than equity as an alternative to a conventional bank loan.
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Fierce Medtech Names Tasso as One of Its “Fierce 15” Med Tech Companies of 2021
Tasso, Inc., a leader in clinical-grade blood collection technology, today announced that it has been named by Fierce Medtech as one of 2021’s Fierce 15 med tech companies, designating it as one of the most promising private med tech companies in the industry.
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Venari Medical announces publication of pre-clinical data in leading scientific journal Phlebology and changes name to InVera Medical™
InVera Medical™ (formerly known as Venari Medical) are delighted to announce the publication of its pre-clinical feasibility study of the InVera™ minimally invasive, exclusively mechanical venous ablation device in Phlebology, an official journal of several international venous societies.
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MindMaze to advance digital neurotherapeutics with $105-million raise
MindMaze announced Thursday that it secured a $105-million financing round to accelerate its global growth plans, support ongoing R&D and consolidate the clinical development pipeline of its digital therapeutic solutions for neurological diseases.
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Epitel Secures $12.5 Million Series A Financing for Wearable, Wireless EEG Monitoring System
Epitel introduces REMI, a wearable, wireless EEG monitoring platform for seizure detection. Epitel’s first FDA-cleared product can be rapidly and easily applied by a nurse or hospital technician.
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Orthox Closes $12.5m Series A Financing for Clinical Trials of Knee Cartilage Repair FibroFix™ Product Platform
Orthox Limited, a clinical stage company developing medical implants to repair damaged knee articular cartilage and other orthopaedic injuries, announces the completion of a further $4.3m (£3.2m) to close its $12.5m (£9.2m) Series A financing round.
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Day Zero Diagnostics Announces Completion of $21M Financing
Day Zero Diagnostics, Inc., an infectious disease diagnostics company harnessing the power of whole-genome sequencing and machine learning to combat the rise of antibiotic-resistant infections, announced the completion of a $21M venture equity financing.
Feb 8, 2022 Entrepreneurship Impact Spotlights News and Events From Plastic Surgeon-in-Training to Inventor: How a Family Tragedy Led One Latina to Improve Lung Disease Diagnosis for the World
Maria Artunduaga is the CEO and founder of Samay, a successful startup aimed at providing low-cost, at-home diagnostics for dangerous respiratory conditions.
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Koya Medical secures US$26 million in Series B funding to advance portfolio of active compression therapies for lymphoedema and venous disorders
Koya Medical has announced the close of a US$26 million Series B financing. The round was led by 3×5 Partners, along with new investors including Asahi Kasei Ventures, Cadence Healthcare Ventures, and existing investors Arboretum Ventures and Scientific Health Development, among others.
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CroíValve Raises an €8M Series A Round to Support a Feasibility Clinical Study Expands the Board of Directors and Leadership Team
CroíValve, a Dublin based medical device company developing a novel treatment for tricuspid regurgitation, has raised a Series A round to fund a Feasibility clinical study with its DUO Coaptation Valve system.
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Applaud Medical wins FDA breakthrough device designation for urinary stone device
Applaud Medical Inc. has secured breakthrough device designation from the FDA for its acoustic enhancer technology to be used in conjunction with ureteroscopy with laser lithotripsy (URS-LL) for the fragmentation of calcium-based urinary stones.
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Vynca Secures $30 Million in Funding to Expand Integrated Palliative Care Platform
Vynca, a leading technology-enabled provider of holistic care for those with serious illnesses, raised $30 million in growth capital. The investment was led by Questa Capital with participation from existing investors including Generator Ventures, First Trust Capital Partners, 4100 Group and OCA Ventures.
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SafeHeal Closes €40 Million Financing Co-Led by Sofinnova Partners and Genesis MedTech To Finance Its Colovac Device Through a Pivotal Clinical Trial in the United States
SafeHeal, a leading innovator in the field of digestive surgery and developer of the Colovac device, announced today a successful 40M€ financing, co-led by Sofinnova Partners and Genesis MedTech Group.
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New Procedure to Revolutionise Paediatric Ear Surgery Performed for the First Time using AventaMed Solo + Tympanostomy Tube Device (TTD)
Immediately after the procedure, Dr. Pimentel said, “The case went very well – even better than I imagined. The child did very well during the brief procedure which lasted less than 5 minutes.
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BioVentrix Expands Heart Failure Treatment Portfolio with Acquisition of MateraCor, Inc.
BioVentrix, Inc., a privately held medical device company focused on less invasive therapies to treat the left ventricle (LV), known to be the root cause of congestive heart failure (CHF), today announced that it has acquired MateraCor, Inc., a company focused on preventing progression of, and reversing, heart failure through the use of injectable alginate-based hydrogel.
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CoapTech Awarded Seed Fund Grant from Pennsylvania Pediatric Device Consortium
CoapTech, Inc, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced today it has been awarded a $50,000 grant by the Children’s Hospital of Philadelphia-based Pennsylvania Pediatric Medical Device Consortium (“PPDC”) for its PUMA-G Peds System, a device designed to provide a safer way to place feeding tubes in children.
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Distalmotion Raises $90M to Accelerate Adoption of Surgical Robot Dexter
Distalmotion announced today the closing of a USD 90 million Series E financing to support the global commercialization of its surgical robot Dexter. Revival Healthcare Capital (Revival) led the round with participation from 415 CAPITAL (415), as well as existing investors.
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Spect Is Fighting Blindness With a New Portable Eye Camera and Tele-Ophthalmology Platform
ChallengeToday, one in three Americans are diabetic or pre-diabetic. Globally, that number stands near a half billion, according to the WHO. In the best-case scenario, when a person is diagnosed with diabetes (typically type II), they’re under the care of a primary care physician.
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Iterative Scopes Announces $150 Million Series B to Advance AI-Driven Precision Medicine for Gastroenterology
Series B round co-led by leading global investment firms Insight Partners and Clearlake Capital, with participation from existing investors
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Pops Self-care Platform Users Achieve Significantly Improved HbA1c Results in Clinical Study Published in the International Journal of Digital Health
The International Journal of Digital Health has published the 24-month clinical study results showing a sustained and significantly improved HbA1c result for people with diabetes utilizing the Pops Self-care Platform for self-management. https://www.graphyonline.com/archives/IJDH/2021/IJDH-107/
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Orbit Genomics Raises $3 Million to Launch a Lung Cancer Diagnostic Test
Orbit Genomics, Inc., an early-stage genomics company, today announced that it has received $3 million in funding to launch its first product, OrbiSeq™ – L, a lung cancer diagnostic test which demonstrated significantly higher accuracy than any test currently marketed.
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Strados Labs, Growing Medtech Company, Raises $4.5M in Pre-series A Funding Round
Strados Labs, a medical technology company harnessing the power of smart sensors, machine learning and proprietary algorithms to provide early detection and predictions of worsening respiratory diseases, today announced its pre-series A round of funding at $4.5M.
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COPD Foundation and Wellinks Collaborate to Evaluate Integrated Virtual COPD Management Solution
The COPD Foundation, a patient advocacy and research organization, and Wellinks, a digital health care company offering the first-ever integrated, virtual chronic obstructive pulmonary disease (COPD) management solution, today announced a partnership to recruit eligible patients for a new research study through the Foundation’s COPD Patient-Powered Research Network (COPD PPRN).
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Caira Surgical Secures $5M Series Seed Financing to Develop New Standard of Care Navigation and Robotic Solutions for Joint Replacement Surgery
Caira Surgical announced its latest influx of $5M seed capital in an oversubscribed series seed financing that closed last month. Caira’s investor syndicate includes smart-money venture and strategic MedTech investors.
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Telemedicine Startup Spect Raises $3.5 Million to Build Digital Eye Screening Platform
Spect is a telemedicine startup company that leverages artificial intelligence (AI) to diagnose eye diseases in patients. The startup business recently secured $3.5 million in new funding from investors to help accelerate the growth of its company and telemedicine platform.
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Rhaeos, Inc. Raises $2.2 Million in Oversubscribed Seed Round
Rhaeos, Inc., a private, clinical stage medical device company developing a platform wireless and non-invasive wearable sensor initially targeting the neurosurgical suite, today announced the successful closing of its oversubscribed $2.2 million seed financing.
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Conavi signs $20m funding deals for Novasight Hybrid system
The system facilitates simultaneous imaging of coronary arteries with both intravascular ultrasound and optical coherence tomography
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Tasso Secures $100M in Series B Financing
Tasso, Inc., a leader in clinical-grade blood collection technology, today announced that it has completed an oversubscribed $100 million Series B financing round, bringing the total funding to date to $131 million.
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Severe Heart Failure Treatment : FineHeart Completes its Series B Funding Taking the Total to €21 Million
FineHeart S.A, a preclinical medical device company that has developed the ICOMS FLOWMAKER®, an Implantable Cardiac Output Management System designed to address the unmet need of patients suffering from severe heart failure, today announced further funding of €6 million bringing the Series B total to €21 million, giving FineHeart a cash runway until the end of 2023.
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Irish start-up Altratech raises €5m for molecular detection research
The company’s team of 20 scientists and engineers are working on ‘next-generation molecular detection’.
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Neonatal Incubator Developed by mOm and eg technology Achieves First Clinical Use in the UK
Created by mOm Founder & CEO, James Roberts, and developed by mOm & the engineering team at eg technology, this innovative, lightweight incubator helped to sustain a premature baby’s life at St Peter’s Hospital, Chertsey.
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Tympany Medical raises €3.5m for specialised ear surgery device
Galway-based medtech company Tympany Medical has raised €3.5 million in a seed investment round from backers that include the venture arm of the Mayo Clinic, which has been consistently ranked as the best hospital in the US.
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FDA approves Neurent Medical’s NEUROMARK to treat chronic rhinitis
Neurent Medical has secured approval from the US Food and Drug Administration (FDA) for its NEUROMARK Rhinitis Neurolysis Therapy (RNT).
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Strados Labs Granted CE Mark for its RESP™ Smart Sensor Platform
Strados Labs, a medical technology company harnessing the power of smart sensors to aid in early detection and predictions of worsening diseases for enhanced patient care, announced today it was granted a CE Mark for the Company’s RESP™ Smart Sensor Platform for respiratory health.
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Avodah Closes $7 Million Seed Round to Scale Digital Healthcare Platform with AI Capabilities
Avodah, a transformative SaaS company powering human-centered integrated artificial intelligence (AI) capabilities, announced today closing $7 million in seed funding to advance AvodahMed’s digital healthcare platform.
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U.S. Department of Defense Awards Prenosis Up to $4.3 Million to Improve Early Sepsis Identification for Warfighters Using Point-of-Care Predictive Diagnostics
Prenosis to provide enhanced Sepsis identification in remote environments with portable “Prenostics”, promising a new era of preemptive and precise diagnostic testing
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PathologyWatch Raises $25M to Advance AI-Driven Skincare Research and Diagnostics
The Series B funding round will help PathologyWatch digitize biopsies, increase access to top skincare physicians, and further AI research
Eko Launches the Next-Generation DUO
Eko, a cardiopulmonary digital health company, has launched the next-generation Eko DUO. DUO is the first U.S. Food and Drug Administration (FDA)-cleared cardiac assessment tool that functions as an electrocardiogram (ECG) and digital stethoscope to detect early signs of heart disease and facilitate timely care and personalized disease management.
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The 6 most high-profile device company acquisitions in 2021 (featuring 7D Surgical)
From Johnson & Johnson’s latest robotics acquisition to NuVasive’s acquisition of an emerging spine technology, here are six medtech deals that caught the eye of readers in 2021.
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Nihon Kohden Buys Advanced Medical Predictive Devices, Diagnostics, and Displays (featuring AMP3D)
Nihon Kohden, a global leader in precision medical products and services, has acquired Advanced Medical Predictive Devices, Diagnostics and Displays Inc.
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FDA clears the nView s1 imaging system with integrated navigation
nView medical Inc. (nView) announces the 510(k) clearance of the nView s1 with navigation option by the U.S. Food and Drug Administration (FDA).
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National Health Care Associates and Circadia Technologies Announce Partnership to Enhance Positive Health Outcomes for Seniors
National Health Care Associates Inc., a network of affiliated skilled nursing, rehabilitation and assisted living centers throughout the northeast, and Circadia Technologies Ltd.
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Wellinks nabs $25M for virtual solution that treats COPD using medical devices linked with an app
Wellinks has raised $25 million in series C funding for its virtual platform for treating chronic obstructive pulmonary disease (COPD), the company announced Wednesday.
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Biolinq secures $100m funding for wearable glucose biosensor platform
The company intends to utilise the funds to support the development of world’s smallest microarray of sensors for continuous glucose monitoring
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Fogarty Innovation Graduate Raydiant Oximetry Raises $5 Million in Oversubscribed Series A2 Financing Round to Support Clinical Study
Innovative technology designed to keep mothers and babies safe during childbirth
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MY01 Continuous Compartmental Pressure Monitor granted Breakthrough Device Designation from the FDA
The Breakthrough Device Designation is an FDA designation granted to devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
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Sibel Health Gets 510(k) Clearance for Wireless Medical Monitor
Sibel Health has received its first 510(k) marketing clearance from the FDA for its Anne One wireless vital signs monitoring platform.
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INVEST Pitch Perfect winner spotlight: Strados Labs and its ‘Holter for the lungs’
Strados Labs has developed a wearable device that senses lung sounds in patients with asthma, COPD, and other respiratory disorders. The startup, which has FDA clearance and a growing list of customers, was judged the winner in the Pitch Perfect competition at MedCity News’ recent INVEST Digital Health conference.
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PhotoniCare CEO, Ryan Shelton, Wins NWA Pitch Competition
The Northwest Arkansas Tech Summit declared Ryan Shelton, CEO and Co-founder of PhotoniCare, as winner of the pitch competition.
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CorWave receives 2021 HealthTech Award in medtech
Organised by France Biotech, the French professional association of healthtech entrepreneurs, the event rewards the companies that have made the biggest impact on the sector this year.
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Kheiron partners with Waleed Pharmacy in Oman
Mia®, a deep learning artificial intelligence (AI) solution that works with radiologists to improve breast cancer detection, avoid unnecessary biopsies and ultimately improve the patient experience for all women is being launched in Oman.
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CathWorks FFRangio System Granted National Reimbursement Approval in Japan
CathWorks announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has agreed to provide reimbursement for the CathWorks FFRangio System, making it more broadly available for coronary artery disease decision-making in Japan.
GT Medical Technologies Wins Prestigious Innovator of the Year Award at the 2021 Governor’s Celebration of Innovation
GT Medical Technologies, Inc. today announced it was named a winner of the Innovator of the Year in the small company category at the 2021 Governor’s Celebration of Innovation, presented live on stage by the Arizona Technology Council and the Arizona Commerce Authority on October 13.
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Wristband to Detect Strokes: Interview with Sandra Saldana, CEO of Alva Health
Medgadget had the opportunity to speak with Sandra Saldana, CEO & Co-Founder of Alva Health about the firm’s technology.
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HealthTech Arkansas picks 5 for new cohort
Startup incubator and new business accelerator HealthTech Arkansas has selected five new companies to participate in its next cohort that launches on Nov. 2.
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How AI is helping to make breast cancer history, featuring Kheiron
Every October for the last four decades, Breast Cancer Awareness Month has helped to raise visibility of the most prevalent cancer on Earth — one that takes almost three-quarters of a million lives every year.
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Global Healthcare Exchange Announces Acquisition of Explorer Surgical
Global Healthcare Exchange (GHX) today announced it has acquired Chicago-based Explorer Surgical Corp., operator of a comprehensive digital and remote case support platform that connects suppliers with healthcare provider teams.
Global Healthcare Exchange Announces Acquisition of Explorer Surgical
Global Healthcare Exchange (GHX) today announced it has acquired Chicago-based Explorer Surgical Corp., operator of a comprehensive digital and remote case support platform that connects suppliers with healthcare provider teams.
Subtle Medical Receives Health Canada Approval for Increased Imaging Efficiency
Subtle Medical, a healthcare technology company improving the quality and efficiency of medical imaging, announced today Health Canada/Santé Canada approval for their suite of AI-powered image enhancement solutions.
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Prenosis Announces Partnership to Combat Hospital Sepsis Using Precision Diagnostics
Prenosis, Inc., a precision diagnostics company transforming clinical diagnosis with predictive intelligence, announced today the expansion of an existing partnership with Roche Diagnostics that will total close to $6M to improve and expedite the clinical recognition of sepsis through advanced precision diagnostics.
Subtle Medical Receives Health Canada Approval for Increased Imaging Efficiency
Subtle Medical, a healthcare technology company improving the quality and efficiency of medical imaging, announced today Health Canada/Santé Canada approval for their suite of AI-powered image enhancement solutions.
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Novian Health Granted FDA Breakthrough
FDA also granted breakthrough designation to Novian Health’s laser therapy for breast cancer. The minimally invasive system is designed to destroy tumors using laser ablation, enabling breast cancer patients to get treated without surgery.
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How COVID-19 drove the need to make physicians’ lives easier featuring MedAware
Electronic health record burnout is a global issue that, like everything else in healthcare, has been exacerbated by the COVID-19 pandemic.
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Leading Pregnancy App Babyscripts Announces Partnership With Nuvo Group to Deliver First-of-its-Kind Comprehensive Remote Pregnancy Care Solution
Babyscripts, the leading virtual care platform for managing obstetrics, announced today that they are entering into a collaboration with Nuvo Group, a company commercializing INVU by Nuvo™, an FDA-cleared, prescription-initiated, remote pregnancy monitoring platform.
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Knee Kinesiography – Recognized by the American Association of Orthopaedic Surgeons (featuring Emovi)
The American Academy of Orthopedic Surgeons has just recognized that when integrated in patient education, Knee Kinesiography with the KneeKG system provides statistically significant and clinically superior improvements compared to the results obtained with current standard of care.
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MEET THE 2021 FOURTH REVOLUTION AWARD WINNERS, feat Rhaeos
The FlowSense technology was born out of the Rogers Research Lab at Northwestern University. Leading engineers and neurosurgeons recognized an unmet clinical need in hydrocephalus patients and developed a technology to assess fluid flow subdermally in shunts.
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This startup wants to build a needle-free CGM using nanotechnology
Graphwear co-founders Saurabh Radhakrishnan and Rajatesh Gudibande want to make CGMs that use nanotechnology to measure blood glucose levels.
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MindMaze Group Secures USD 125 Million Financing to Accelerate Commercialization and Expansion of its Digital Neurotherapeutics Platform
MindMaze, a global pioneer in the multibillion-dollar digital neurotherapeutics market, today announced the closing of a USD 125 millioninvestment round that will be utilized to drive the continued growth of its SaaS-based digital neurotherapeutics platform.
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Magellan Healthcare Debuts High-Touch, High-Tech Collaborative Care Management Solution Powered by NeuroFlow
Magellan Healthcare, the behavioral and specialty healthcare division of Magellan Health, Inc. (NASDAQ: MGLN), today announced a collaborative care management solution for health plans and providers that will enhance behavioral healthcare services delivered in physical healthcare settings.
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Magellan Healthcare Debuts High-Touch, High-Tech Collaborative Care Management Solution Powered by NeuroFlow
Magellan Healthcare, the behavioral and specialty healthcare division of Magellan Health, Inc. (NASDAQ: MGLN), today announced a collaborative care management solution for health plans and providers that will enhance behavioral healthcare services delivered in physical healthcare settings.
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Meet cellvie founder Alexander Schueller and find out how he leverages the power of evolution through mitochondria therapy
Many of us remember learning about the mitochondria, the powerhouse of the cell, in school. But few of us learned what happens when the cell’s powerhouse no longer works properly: Mitochondria dysfunction has been tied to many medical conditions, including heart disease, stroke, diabetes, Parkinson’s, and Alzheimer’s.
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DZD Wins Disruptive Technology Award at the 2021 AACC Annual Scientific Meeting
Day Zero Diagnostics, Inc., an infectious disease diagnostics company harnessing the power of whole-genome sequencing and machine learning to combat the rise of antibiotic-resistant infections, has won the 2021 Disruptive Technology Award from The American Association for Clinical Chemistry (AACC) and the Audience Choice Award.
Nanowear Receives FDA 510(k) Platform Clearance to Implement Forthcoming AI-based Diagnostics in its Closed Loop Hospital-at-Home Network
Nanowear, a leading hospital-at-home and remote diagnostic platform informed by proprietary cloth nanotechnology and AI, today announced that it received its third FDA 510(k) clearance and first software-only clearance as an end-to-end digital platform, illustrating unique capabilities available to enterprise customer channels across a broad spectrum of diagnostic and monitoring verticals.
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Who won the INVEST Digital Health Pitch Perfect contest? feat. Strados Labs
The INVEST Digital Health Pitch Perfect contest spotlighted 18 companies across three categories: home health, chronic disease management and value-based care, and technology to support payer and provider efficiency. So who emerged as the winners and how did the judges arrive at their choices?
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BARDA partners with Aidar Health, Inc. to develop and validate machine learning algorithm for rapid health assessment and patient triage
Integrated devices and artificial intelligence (AI)-enabled technologies like AIDI have the potential to provide early and actionable health status information to empower individuals and health care providers.
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Who won the INVEST Digital Health Pitch Perfect contest? (featuring Strados)
The INVEST Digital Health Pitch Perfect contest spotlighted 18 companies across three categories: home health, chronic disease management and value-based care, and technology to support payer and provider efficiency. So who emerged as the winners and how did the judges arrive at their choices?
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BARDA partners with Aidar Health, Inc. to develop and validate machine learning algorithm for rapid health assessment and patient triage
Integrated devices and artificial intelligence (AI)-enabled technologies like AIDI have the potential to provide early and actionable health status information to empower individuals and health care providers.
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Is India geared up for regular screening of CHDs in kids?
Chennai: Congenital Heart Defects (CHDs) are among the most common types of birth defects. One out of 100 babies is born with CHD worldwide and nearly 40,000 infants in the US are born with CHD each year.
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Is India geared up for regular screening of CHDs in kids? (featuring HD Medical)
Chennai: Congenital Heart Defects (CHDs) are among the most common types of birth defects. One out of 100 babies is born with CHD worldwide and nearly 40,000 infants in the US are born with CHD each year.
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21 start-ups selected to innovate for healthy ageing, feat. SepTec
The awards are part of the Healthy Longevity Global Competition – a multiyear, multimillion-dollar international competition seeking breakthrough innovations to extend human health and function later in life.
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Xealth Secures $24 Million in Series B Funding to Accelerate Digital Health
Xealth, the leader in enabling digital health at scale, today announced that the company has secured $24 million in Series B funding led by Advocate Aurora Enterprises, a subsidiary of Advocate Aurora Health.
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Co-founder of Avisi Technologies named one of the Greater Philadelphia’s Inno Under 25
Along with co-founder Brandon Kao, Rui Jing Jiang started Avisi Technologies in 2017, developing VisiPlate, a nanotechnology-enabled ocular implant to treat glaucoma.
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Co-founder of Avisi Technologies named one of the Greater Philadelphia’s Inno Under 25
Along with co-founder Brandon Kao, Rui Jing Jiang started Avisi Technologies in 2017, developing VisiPlate, a nanotechnology-enabled ocular implant to treat glaucoma.
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Bluegrass Vascular Announces Decision by Medicare to Assign a New Technology Ambulatory Payment Classification (APC) for the Surfacer® System Procedure
Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that the Centers for Medicare & Medicaid Services (CMS) has finalized a new Healthcare Common Procedure Coding System (HCPCS) code and New Technology Ambulatory Payment Classification (APC) assignment for use of the Surfacer® Inside-Out® Access Catheter System (Surfacer System) procedure.
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Rhaeos, Inc. Awarded $4 Million NIH SBIR Grant to Expand Quantitative Measurement Capabilities of its FlowSense™ Noninvasive Wireless Sensor
Rhaeos, Inc., a private medical device company focused on the care of patients with hydrocephalus, announced today it was awarded a $4 million, multi-year grant from the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program through the National Institute of Neurological Disorders and Stroke (NINDS).
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Vertigo Treatment Receives FDA Breakthrough Device Designation, featuring Otolith Labs
“We’ve heard repeatedly from participants in our clinical studies that the Otolith technology brings instant relief from their vertigo symptoms, some of whom have described the treatment as life-changing,”
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Madorra wins FDA breakthrough nod for home vulvovaginal atrophy treatment device
Madorra this week said it has received FDA breakthrough device designation for its noninvasive, home-use device for moderate to severe vulvovaginal atrophy.
Nutromics won in the category of ‘Technology Platform Solution of the Year’ at the AIIA’s 2021 national iAwards!
We are excited to announce that last night Nutromics won in the category of ‘Technology Platform Solution of the Year’ at the AIIA‘s 2021 national iAwards!
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InBrace Raises $102M Series D Financing
InBrace, the orthodontic company behind the novel Smartwire™ category of behind-the-teeth, teeth straightening, today announced the closing of an oversubscribed $102 million Series D financing by funds affiliated with new investor groups co-led by Farallon Capital Management, L.L.C.
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Stryker Acquires Med Device Company Gauss Surgical
– Stryker today announced the acquisition of Gauss Surgical, a Menlo Park, CA-based medical device company that has developed Triton™, an artificial intelligence-enabled platform for real-time monitoring of blood loss during surgery. Financial details of the acquisition were not disclosed.
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Sentien Biotechnologies Partners with BARDA to Evaluate High Dose Cohort in Phase 1/2 Trial of SBI-101 for Treatment of Acute Kidney Injury Associated with Sepsis
Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, today announced a partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S.
Onkos Surgical raises $15M Series C
Onkos Surgical, a leading innovator of solutions for musculoskeletal oncology and complex orthopedic procedures based in Parsippany, announced Wednesday that it has raised $15 million in Series C funding from its existing investor syndicate.
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Australian medtech startup Nutromics bags $4M in pre-market funding for continuous molecular monitoring device
Nutromics, an Australian medical technology startup, has raised A$5.7 million ($4.1 million) in a pre-market funding round participated by private investors. This brings its total capital raised in the past three years to A$10 million ($7.2 million).
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Eclipse Regenesis Awarded National Institutes of Health (NIH) Grant
Eclipse Regenesis, Inc., developer of the first restorative therapy to address pediatric and adult Short Bowel Syndrome, has been awarded a National Institutes of Health Small Business Innovation Research (NIH SBIR) Fast Track grant of $1.7 million.
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Genetesis Announces New Scientific Advisory Board
Genetesis, the market leader in the design, development and commercialization of biomagnetic imaging solutions, today announced its new Scientific Advisory Board (SAB).
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Trinity Health Mid-Atlantic teams with NeuroFlow to offer mental health app to workers
Independence Blue Cross Foundation is teaming up with Trinity Health Mid-Atlantic and health tech company NeuroFlow to support its workers’ mental health.
Lightpoint Medical and Telix Pharmaceuticals Announce Strategic Collaboration Agreement
Lightpoint Medical, a leading medical device company developing and marketing miniaturized imaging and sensing tools for minimally-invasive and robot-assisted surgery, announced today that it has signed a strategic collaboration agreement with Telix Pharmaceuticals Limited.
1st Covid Vaccine For Children Above 12 Approved In India, featuring PharmaJet
India’s drug regulator on Friday approved Zydus Cadila’s three-dose COVID-19 DNA vaccine for emergency use in adults and children aged 12 years and above, bringing in the sixth vaccine authorised for use in the country.
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CloudCath, American Renal Associates Partner on Dialysis Study
CloudCath, developer of a remote monitoring and predictive analytics platform for catheter-based treatments, is collaborating with American Renal Associates (ARA), a leading provider of outpatient dialysis services.
Scancell Holdings PLC to use needle-free technology for next-generation vaccine candidates, featuring PharmaJet
Scancell Holdings PLC (AIM:SCLP, FRA:SCP) (AIM:SCLP) said it will use PharmaJet’s needle-free technology to administer Covid vaccine candidates SCOV1 and SCOV2 in its COVIDITY phase I clinical trial.
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Ischemia Care Launches Gene Signature LDT to Detect and Differentiate Stroke
Molecular diagnostic testing for stroke is in its infancy, but Ischemia Care…
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Auctus Surgical: FDA Breakthrough Device Designation, Key Patent for Non-Fusion Scoliosis System
Auctus Surgical, a company devoted to non-fusion options for scoliosis patients, is developing a one-of-a-kind vertebral body tethering (VBT) system to treat pediatric scoliosis with a non-fusion, dynamic approach.
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Koya Medical Secures First Reimbursement Codes for Dayspring, for Lymphedema; Publishes Clinical Data Demonstrating Improved Function, Appearance, Mood and Symptoms
Koya Medical, a healthcare company focused on developing breakthrough treatments for lymphedema and venous diseases, announced today that its wearable, active compression therapy system for lymphedema—Dayspring™— was issued new billing codes by the Center of Medicare & Medicaid Services (CMS) in accordance with the Healthcare Common Procedure Coding System (HCPCS).
Encellin Closes $5.9M Seed Co-Led by Khosla Ventures and SV Latam Capital
Encellin, a personalized regenerative medicine biotech company developing novel cell-based approaches to deliver sustained therapies with a single implant, today announced the closing of a $5.9M Seed financing round.
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Embody Announces $20.5M Funding Round
Embody, Inc., a privately-held medical device company focused on soft tissue healing, announced today that it has secured $11.5 million in an oversubscribed equity financing and entered into a debt financing agreement led by Horizon Technology Finance Corporation (NASDAQ: HRZN) (“Horizon”) to provide up to $9 million in term loans, of which an initial $5 million has been funded, for a total of $20.5 million in available funds.
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AI Health Startup Iterative Scopes Raises $30M Series A
Iterative Scopes, a Massachusetts-based AI Health startup, raised $30 million in Series A funding to apply the potential of AI to gastroenterology.
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OrthoPediatrics, Mighty Oak Medical Extend Partnership
“Our partnership with OrthoPediatrics is based on a shared mission and passion to help each child who is experiencing a medical challenge. Knowing how much is at stake, the Mighty Oak team has dedicated itself to providing the most detailed concierge presurgical plans, the most exact spine models, and the most accurate patient-specific spine guides available anywhere in the world.
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US Naval Academy Awards New NeuroFlow Contract to Support the Well-Being and Endurance of USNA Midshipmen
– NeuroFlow, a provider of technology and services for the integration of behavioral health, has been hired by the US Naval Academy to support the well-being of the Midshipmen during their 47-month journey to be commissioned as naval officers.
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Amwell acquires two digital health startups for $320M as Telehealth M&A Frenzy Continues, featuring SilverCloud Health
Amwell is acquiring two digital health startups for a combined $320 million as the publicly traded telehealth company looks to expand its platform offerings beyond the Covid-fueled virtual care boom.
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Saranas snags $12.8M Series B
A Houston company that’s changing the game when it comes to early bleed detection has raised its next round of funding.
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Evren Technologies receives FDA Breakthrough Device Designation for the Phoenix®
Evren Technologies, Inc. announced today that its non-invasive Phoenix® earbud device received Breakthrough Device Designation from the U.S. Food and Drug Administration for the treatment of Post-traumatic Stress Disorder (PTSD).
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Top Boston Startups to Watch in 2021, featuring Day Zero Diagnostics
The Boston startup ecosystem is one of the most active and thriving in the world, which also means that there are a lot of top startups in Boston. The total early-stage startup funding in the ecosystem dwarves the global average of $431 Million with a total of $3.9 Billion.
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Business of Health: Fast BioMedical Named Top MedTech Startup
MedTech Innovator has unveiled its Top 50 Medtech Startups Selected for its annual showcase. Indiana’s own FAST BioMedical was one of just few startups in the Midwest to be selected. Joe Muldoon explains how his startup is working to transform patient care through innovation.
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Surmodics acquires Vetex Medical to boost thrombectomy portfolio
Medical device and in vitro diagnostics company Surmodics has acquired Ireland-based medical device maker Vetex Medical to extend its thrombectomy portfolio.
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Medtech firm IntuiTap Medical raises $5.5M Series A for clinical trials
IntuiTap Medical develops a device aimed at making the administration of spinal injections more accurate and efficient for health care providers.
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Osso VR raises $27M to train surgeons via simulations
Osso VR has raised $27 million to train doctors and other medical professionals using virtual reality surgery simulations.
Putting digital therapeutics to work for mental health, featuring SilverCloud Health and Xealth
National Institute of Mental Health data shows that more than 17.3 million U.S. adults have suffered from an episode of major depression in the past year, and one in three are afflicted by an anxiety disorder. Mental health conditions often go underdiagnosed and undertreated.
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Alio Raises $20M Series B
Alio Medical, a wearable technology company enabling greater insights through clinical grade real-time data, announced the close of a Series B financing round totaling $20 million.
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Mobility-Enabled Compression Device for Lymphedema: Interview with CEO of Koya Medical
Koya Medical, a medtech company based in California, has developed the Dayspring active compression system for the treatment of lymphedema. The company received FDA clearance for the use of Dayspring on the upper extremities in June 2020, and just recently announced 510(k) clearance for use in the lower extremities.
Onkos Surgical wins FDA clearance for BioGrip 3D-Printed implant
Onkos Surgical today announced that it received FDA 510(k) clearance for its BioGrip 3D-printed implant technology.
Bone Health Technologies Receives Patent for OsteoBoost Vibration Belt
Bone Health Technologies, an innovator of progressive new therapies for improving bone health, announced that the United States Patent and Trademark Office (USPTO) has awarded its second patent for the OsteoBoost Vibration Belt.
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Vivante Health Expands Product Suite to Include the GIMate
Vivante Health, the leader in digital medicine for digestive health and disease, proudly announces the GIMate, a first-of-its-kind handheld breath hydrogen monitor.
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Neurescue’s Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest
Neurescue, a medical device company developing innovative cardiovascular solutions to improve the outcomes for emergency patients, today announced that the U.S.
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CloudCath Announces Collaboration with American Renal Associates in Pre-Market Clinical Study for Peritoneal Dialysis Patients
CloudCath, developer of a remote monitoring and predictive analytics platform for catheter-based treatments, today announced a collaboration with American Renal Associates (ARA), a leading provider of outpatient dialysis services.
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A Conversation With Sana Health’s Richard Hanbury
For me, the Sana Health device was truly a gift from the universe. I’ve been very open about my struggles with pain stemming from my autoimmune disorders and I was extremely grateful when representatives at Sana connected with me and offered to send me a device to help with my healing.
Localized Prostate Cancer Therapy: Interview with Shyam Natarajan, CEO of Avenda Health
Avenda Health, a medtech company based in Santa Monica, California has developed the Focal Therapy System. It provides AI-powered prostate cancer therapy with the aim of treating only tumorous tissues, while reducing side-effects compared with conventional therapies.
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Medical Device Company FineHeart Successfully Raises €15 million
FineHeart S.A, a preclinical medical device company that has developed theICOMS FLOWMAKER®, an Implantable Cardiac Output Management System designed to address the unmet need of patients suffering from severe heart failure, today announced the successful completion of a €15 million funding round.
Empirical Spine Closes $10 Million Series B Financing
Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced the closing of a Series B financing of $10 million. SHD (Scientific Health Development) led the round, with additional investment from GP&G (Green Park & Golf) and other syndicate members.
Zenflow Announces $24 Million Financing Round; Appoints Susan Stimson as President
Zenflow, Inc., a medical device company developing a minimally invasive treatment for urinary obstruction caused by enlarged prostate, or benign prostatic hyperplasia (BPH), today announced that it has closed a $24 million Series B financing round.
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PAVmed Launches Digital Health Company Veris Health Inc.
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical technology company, today announced the launch of a new subsidiary, digital health company Veris Health Inc.
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Medical device-maker Allotrope Medical raises $4M Series A round
Houston-based medical device company Allotrope Medical Inc. raised a $4 million funding round, the firm announced June 1.
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Venari Medical: Galway medtech with a potentially life-changing device
NUI Galway BioInnovate spin-out Venari Medical has developed a minimally invasive medical device that it hopes can tackle CVD at early and extreme stages.
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BrainSee Enterprise Software Is Reliable, Accurate for Alzheimer’s Disease Detection, featuring Darmiyan
Today the American Society of Neuroradiology published Introducing BrainSee, a summary of study results presenting the 91 percent accuracy rate of the new AI-powered and patented technology by Darmiyan Inc.
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Forest Devices Announces That FDA Has Designated the AlphaStroke Technology a Breakthrough Device
Medical technology pioneer Forest Devices, Inc. (FDI), a medical device company focused on identifying patients with large vessel occlusive (LVO) strokes in the prehospital environment, today announced that the U.S. Food and Drug Administration (FDA) has designated its AlphaStroke technology as a Breakthrough Device.
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Colorado Awards $8.6M in Grants to Startups, featuring Orbit Genomics
Thirty-six Colorado startups secured almost $8.6 million in grants as part of the Colorado Office of Economic Development and International Trade’s Advanced Industries Accelerator Program.
‘If it’s smooth sailing, then you’re not disrupting big enough’ Glamour article featuring IntuiTap Medical
IntuiTap Medical co-founder Jessica Traver talks to Glamour about reinventing the spinal tap.
Alleviant Medical Announces Presentation of Clinical Data at American College of Cardiology and EuroPCR Conferences
Alleviant Medical Inc., a privately-held medical device company, today announced one-month and three-month follow up data from the first in human clinical study (ALLEVIATE-HF-1) of its technology for the treatment of heart failure with preserved ejection fraction (HFpEF).
This imaging device could be a breakthrough for breast cancer treatment, featuring OncoRes Medical
Having breast surgery to remove a cancerous lump is traumatic enough. Learning that you’ll need another operation to remove cancer cells that the surgeon couldn’t detect the first time only adds to the worry — and the cost.
Avenda Health’s Male ‘Lumpectomy’ Receives Breakthrough Device Designation
Avenda Health has been awarded Breakthrough Device Designation for a male “lumpectomy” product in development designed to treat prostate cancer in-office while preserving quality of life.
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PolyVascular Awarded $2 Million Small Business Innovation Research Grant to Bring the First Polymer-Based Heart Valve for Children to Clinical Trials
PolyVascular, leading the effort to improve children’s lives with a novel polymeric transcatheter valve (PTV) for children, announced that it was awarded a $2 million Small Business Innovation Research (SBIR) Phase II grant earlier this year to bring its polymeric stent-mounted valve (SMV) to clinical trials within the next two years in an effort to address pediatric congenital heart disease (CHD), which affects over 1 million patients around the world.
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Bigfoot Scores FDA Clearance for Diabetes Management System
Bigfoot Biomedical is a company that MD+DI readers should be quite familiar with by now. In 2017, the diabetes company was selected as the readers’ choice for Medtech Company of the Year.
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Mindera Raises Over $12M Series A-2 Financing
Mindera Corporation today announced a $12.6M Series A-2 capital raise. The round was led by Mountain Group Partners, Rockmont Investments, and Scientific Health Development.
Nanowear announces commercial distribution partnership in A.I.-based post-surgical recovery monitoring
Nanowear www.nanowearinc.com, the leading nanotechnology and A.I.-based remote diagnostic company, today announced a commercial distribution partnership with a world leading aesthetic and reconstructive surgical device-manufacturer, to enhance and optimize post-surgical recovery for both patients and surgeons.
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FineHeart Breaks New Ground With Successful Removal of the ICOMS FLOWMAKER® in a 90-day In-vivo Trial
This study confirms the ICOMS FLOWMAKER’s ability to support cardiac function without any heart alteration after being implanted for 30 days. The device’s unique fixation system allows for easy removal performed on a beating heart, unchanged blood flow, and without trauma to the myocardium.
Bone Health Technologies Closes $2.5M
Bone Health Technologies has closed a $2.5 million funding round and appointed three members to its Board of DIrectors: Karen Drexler; Nancy Lynch, M.D.; and Sam Goldberger, M.D.
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Soundbite Medical Solutions Announces FDA Approval for SoundBite® Crossing System – Peripheral (14P)
The SoundBite® Crossing System – Peripheral (14P) is a recanalization tool, designed to help physician’s placement of conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions (CTOs) in patients suffering from heavily calcified above-the-knee (ATK) and below-the-knee (BTK) peripheral artery disease (PAD).
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PyrAmes Raises $6 Million in Series A Financing
PyrAmes, Inc., a digital healthcare company focused on innovative products for continuous blood pressure monitoring, today announced the completion of a $6 million Series A financing. The investment round was led by GSR Ventures, with co-investments from Keytone Ventures, XTX Ventures and other investors.
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Moving Analytics Raises $6M to Increase Virtual Cardiac Rehab Solutions and Expand Team Amidst Telehealth Industry Growth
Moving Analytics, a telehealth company providing virtual cardiac rehab solutions, today announced it raised $6M in a Series Seed-2 round. The round was led by Aphelion Capital, LLC, through Cardeation Capital, with co-investments by OCA Ventures and Seae Ventures.
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Medable Secures Another $78 Million Funding to Fuel Digital Innovation for Patient-Centered Drug Development
Medable Inc. today announced $78 million in new funding to fuel advances in the delivery of digital and decentralized clinical trials, accelerating the industry’s shift to patient-centered drug development.
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2Morrow Raises $1.5M to Increase Access to Evidence-Based Digital Health
2Morrow, Inc., a leader in offering evidence-based, digital health platforms, announces a $1.5M investment led by Seattle area life science investor WRF Capital.
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Moray Medical Boosts Seed Funding to $5.7 Million
Robotics startup Moray Medical announced it has closed a total of $5.7 million in seed funding, an increase of $2.4 million compared to the initial raise reported in January.
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FDA Grants Donisi De Novo Clearance for Innovative Contact-Free Multiparameter Health Sensing Solution
The U.S. Food and Drug Administration (FDA) has granted Donisi‘s revolutionary contact-free multiparameter measurement system de novo clearance, making Donisi the first to bring this innovative technology to the medical market.
Explorer Surgical raises nearly $2.6M
Explorer Surgical has raised nearly $2.6 million as it brings on medtech company customers looking to communicate with surgeons remotely.
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Empirical Spine’s LimiFlex Device Granted Breakthrough Designation Status
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device status to Empirical Spine Inc.’s LimiFlex Paraspinous Tension Band.
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Sentien Biotechnologies Completes Enrollment of First Cohort in Phase 1/2 Trial of Ex Vivo MSC Therapy for the Treatment of Severe COVID-19
Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, today announced it has completed enrollment of the first cohort in its Phase 1/2 study of SBI-101 for the treatment of severe COVID-19.
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Augmedics, Augmented Reality Surgical Image Guidance Pioneer, Raises $36 Million in Series C Fundraising
Augmedics, a pioneer in augmented reality surgical image guidance, announced today that it has raised $36 million in an over-subscribed Series C financing with an international syndicate of Israel-US investors.
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PolyVascular Awarded $2 Million Small Business Innovation Research Grant to Bring the First Polymer-Based Heart Valve for Children to Clinical Trials
PolyVascular, leading the effort to improve children’s lives with a novel polymeric transcatheter valve (PTV) for children, announced today that it was awarded a $2 million Small Business Innovation Research (SBIR) Phase II grant earlier this year to bring its polymeric stent-mounted valve (SMV) to clinical trials within the next two years in an effort to address pediatric congenital heart disease (CHD), which affects over 1 million patients around the world.
This new artificial heart responds to the patient, featuring CorWave
Heart disease is the world’s biggest killer, and around one in five people in developed countries will suffer heart failure in their lifetime.
Lightpoint Medical Announces $8 Million in Funding to Support Commercial Launch of its Robotic Cancer Detection Probe
Lightpoint Medical, a medical device company developing miniaturized cancer detection tools for robot-assisted surgery, announced today that it has completed an $8 million financing round.
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Endotronix Celebrates 100th Implant Of The Cordella Pulmonary Artery Pressure Sensor For Proactive, Remote Management Of Heart Failure
Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced the 100th global implant of the Cordella Pulmonary Artery Pressure Sensor (Cordella Sensor) by Cardiologist and top worldwide implanter Faisal Sharif, MD of Bon Secours Hospital and Director of Cardiovascular Research at NUIG, both in Galway, Ireland.
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LimFlow Receives Japan PMDA Approval for Clinical Study of Minimally-Invasive Technology Designed to Prevent Amputations in Chronic Limb-Threatening Ischemia Patients
LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved its Clinical Trial Notification (CTN) for the Japanese cohort of the ongoing PROMISE II pivotal trial of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System.
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SeaSpine® Announces Agreement to Acquire 7D Surgical
SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today that it has entered into an agreement to acquire all of the issued and outstanding shares of 7D Surgical, Inc., a privately-held, Toronto-based company, in a cash and stock deal valued at $110 million, subject to customary adjustments.
Up to 10% of intraoperative time is spent on preventable delays, ExplORer Surgical drives improved efficiencies
ExplORer Surgical, the only comprehensive intraoperative case support and workflow platform for surgical teams, is announcing enhanced efficiency and proficiency through its powerful data insight technology.
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Vetex Medical Announces Positive One-Year Outcomes for Revene Thrombectomy Catheter
Vetex Medical Ltd. today announced positive one-year results from a European clinical study of patients with iliofemoral vein thrombus that demonstrated that the ReVene® Thrombectomy Catheter significantly improved their symptoms and quality of life, while reducing their leg swelling.
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Bigfoot Biomedical® Secures up to $57 Million in Combined Debt and Equity Financing from Madryn Asset Management
Bigfoot Biomedical, a company dedicated to better health outcomes for people with insulin-requiring diabetes, announced today that it has secured new financing of up to $57 million from Madryn Asset Management LP, an alternative asset management firm focused on investments in innovative health care companies.
Inflammatix Secures $102 Million in Series D Financing Led by D1 Capital Partners to Commercialize Novel Host Response Diagnostics
Inflammatix, a pioneering molecular diagnostics company, announced today the closing of a $102 million Series D round of financing to support development and commercialization of its novel immune response diagnostics portfolio.
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A bracelet that triggers the production of endorphins, without addiction, featuring Remedee
The start-up, which has already obtained a patent for its invention, hopes to conduct a clinical trial in 2021 and 2022.
Promaxo Receives 510(k) Clearance from the FDA for its Innovational MRI Platform
The United States Food and Drug Administration (FDA) has granted Promaxo, Inc. (Promaxo) a 510(k) clearance for its revolutionary office-based MRI system. The 510(k) clearance enables practices and hospitals to accurately and seamlessly guide prostate interventions under the Promaxo scanner.
Access Vascular, Inc. Secures $20 Million in Series B Financing
Access Vascular, Inc., a company addressing the most common and costly venous access complications, today announced it has closed on a Series B round of financing. TVM Capital Life Science led the round with a $15 million commitment, with existing investors also participating.
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Soundbite Medical Wins Health Canada Approval for PAD Treatment
The privately-held firm recently received Health Canada’s blessing for the SoundBite Crossing System – Peripheral (SCS-P) with the 0.014-inch Active Wire (14P).
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Vetex Medical Receives FDA Clearance for Revene Thrombectomy Catheter
Vetex Medical Ltd. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the ReVene® Thrombectomy Catheter. ReVene uses dual-action technology designed to de-clot peripheral vessels, such as in Deep Vein Thrombosis (DVT), through wall-to-wall contact in a single session without the use of thrombolytics.
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Protembis announces completion of 20 cases in European CE mark study with the ProtEmbo® Cerebral Protection System
Protembis GmbH, a privately held emerging medical device company, announced today the successful completion of 20 clinical cases in its European regulatory study of the ProtEmbo® Cerebral Protection System.
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Redox Raised $45M To Connect Healthcare Data In The Cloud
The Redox cofounders got a taste of the coming digital health revolution while working at Verona, Wisconsin-based Epic Systems in the late aughts. That’s when they saw the hundreds of different interfaces electronic health records needed to connect to within a health system.
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Forest Devices Announces Positive Study Results for Their Stroke Detection Technology
Medical technology pioneer Forest Devices, Inc. (FDI) today announced the publication of positive results from the EDGAR study of its AlphaStroke™ technology in identifying patients with large vessel occlusive (LVO) strokes in emergency departments in the American Heart Association Journal, STROKE.
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MedAware Systems Launches AI Post Market Surveillance for Neuromodulation Devices
MedAware Systems’ Science of Health Informatics (SOHInfo) announces the launch of its comprehensive AI-powered surveillance service for Spinal Cord and Peripheral Nerve stimulation devices from all major manufacturers.
HydroMID Midline Catheter from Access Vascular Receives FDA Clearance
Access Vascular, Inc. today announced FDA clearance of its HydroMID™ midline catheter. HydroMID, which is made of Access Vascular’s proprietary biomaterial that has been shown to reduce thrombus accumulation by up to 97 percent when compared to standard polyurethane catheters,1 is the second device in its planned portfolio to obtain clearance.
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Fibralign Announces Start of European Lymphedema Prevention Clinical Study
Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced enrollment of the first patient in a multi-site, randomized clinical trial in Europe evaluating its BioBridge® Collagen Matrix as a novel preventative treatment for secondary lymphedema.
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Puzzle Medical Devices Inc. Receives U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for Its Revolutionary Minimally Invasive Transcatheter Heart Pump
Puzzle Medical Devices Inc., (www.puzzlemed.com) announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its revolutionary transcatheter pump to address heart failure.
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Flow expands portfolio of brain stimulation technologies with Halo acquisition
Swedish firm Flow Neuroscience has added to its portfolio of brain stimulation technologies for improving mental wellbeing by acquiring US start-up Halo Neuroscience.
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Interventional Robotics Startup Moray Medical Secures $3.3 Million Seed Financing Led by 415 CAPITAL
Moray Medical announced today that it has raised $3.3 million in seed funding led by 415 CAPITAL, which invested alongside a number of prominent medtech entrepreneurs.
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PEDRA™ Technology Receives FDA Breakthrough Device Designation for its PEDRA™ Xauron™ Real-Time Tissue Perfusion System
PEDRA™ Technology, a privately-held company, announced today that the U.S Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for the periprocedural use of its PEDRA™ Xauron™ Perfusion System in the treatment of critical limb threatening ischemia (CLTI).
Alleviant Medical Receives Breakthrough Device Designation From FDA for Transcatheter Technology
Alleviant Medical Inc., a privately-held medical device company, today announced that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its transcatheter technology.
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Israeli AI FemTech solution secures prestigious US cancer grant of $2.3M to advance women’s health (featuring MobileODT)
MobileODT, an Israeli FemTech startup focusing on AI-powered cervical screening, has caught the eye of the US National Cancer Institute (NCI), with the NCI awarding Mobile ODT with a $2.3 million grant.
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Harvard spin-off CELLVIE closes $5M seed round in pursuit of a new treatment modality: therapeutic mitochondria transfer
cellvie Inc., the leader in Therapeutic Mitochondria Transfer (TMT) and a Harvard University spin-off, closes a $5M round to advance its product pipeline, including a first application in rejuvenation.
Lightpoint’s SENSEI robotic gamma probe gains CE mark for sentinel lymph node detection
Lightpoint Medical announced Wednesday that its SENSEI robotic gamma probe received the CE mark for intra-operative detection of sentinel lymph nodes. The company said the approval makes SENSEI the first robotic gamma probe to be commercially available to hospitals in Europe.
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Hillrom Announces Planned Acquisition Of Bardy Diagnostics, Inc.
Hillrom (NYSE: HRC) today announced it has reached a definitive agreement to acquire Bardy Diagnostics, Inc. (BardyDx), an innovator in digital health and a leading provider of ambulatory cardiac monitoring technologies.
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BIRD – Israel-U.S. Binational Industrial R&D Foundation to Invest $7.45M in Eight New Projects, featuring Donisi Health
During its meeting on December 22, 2020, held via video conference, the Board of Governors of the Israel-U.S. Binational Industrial Research and Development (BIRD) Foundation approved $7.45 million in funding for eight new projects between U.S.
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HealthyU’s 7 lead ECG makes it easier to monitor patients remotely
HD medical is hoping to bridge the gap between your home and the doctor’s office with HealthyU, a little device that measures your vital signs remotely and feeds them directly to your medical provider.
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GTT Group’s Patent Equity Fund Ideaship Invests in 8chili to Deploy Revolutionary Surgical Technology to Build the Foundation for Autonomous Surgeries
Ideaship, a patent leveraged venture capital firm that provides patent development support to early-stage startups, announced it has invested in 8chili, Inc. The investment will assist 8chili’s mission to reimagine surgical training and surgeries with 8chili’s patent pending device, NAVIX AIR.
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Koya Medical Closes $11M Financing to Accelerate Treatment for Lymphedema and Venous Disorders
Koya Medical (www.koyamedical.com), a healthcare company focused on treating lymphedema and vein disease, today announced the close of a $11 million Series A investment round.
Promaxo Raises $4.17M in Funding Round Led by Huami Corporation
Promaxo, Inc. (Promaxo), the medical imaging, robotics, and AI technology company, and Huami Corp. (NYSE: HMI) today announced closing an investment round of $4.17M led by Huami.
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Itamar Medical acquires Spry Health to improve remote sleep apnea treatment
Leading Israeli sleep apnea digital health company Itamar Medical has announced its acquisition of Spry Health in a bid to expand its product offerings into remote monitoring and support for the condition.
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Novus Diagnostics gets €2.4M grant for rapid sepsis test
Irish company Novus Diagnostics has been awarded €2.4 million in funding to commercialise its rapid sepsis test.
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NEUROFLOW closes $20M Series B Investment
NeuroFlow, the market leader in solutions supporting technology-enabled behavioral health integration, announces today the initial closing of a $20M Series B financing round led by Magellan Health (NASDAQ: MGLN), in addition to a syndicate including previous investors.
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Rhaeos: Greater Insight for Hydrocephalus Solutions
Though uncommon, hydrocephalus impacts patients’ lives chronically, requiring regular hospital visits to respond to symptoms and simply monitor status.
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CathWorks Announces $30M in New Financing
CathWorks reported the completion of a $30 million Series D financing round. Proceeds from the financing will be used to expand commercialization of the company’s FFRangio system.
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Avisi closed an oversubscribed Seed round
We are elated to announce the closing of our oversubscribed Series Seed financing; we raised ~$2M in 2020, $1M of which was in the form of grant funding from the National Science Foundation (NSF).
How artificial intelligence and augmented reality are changing medical proctoring during COVID-19 (featuring ExplORer Surgical)
Medical device specialists often monitor the work of surgeons to provide case support during procedures in the operating room. However, during the COVID-19 pandemic, medical proctoring has gone remote.
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Vancouver-based Stoko creates products for ‘athletes of all abilities’
Formerly known as Embrace Orthopaedics, the Vancouver-based brand Stoko merges “functional support and activewear” for athletes.
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Mitochondrial Transplantation to Treat Ischemia-Reperfusion Injury: Interview with Dr. Alexander Schueller, CEO of cellvie
cellvie, a company based in Houston, Texas, is developing a mitochondrial transplantation therapy to help reduce the damage caused by ischemia-reperfusion injury.
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Strados Labs receives FDA 510(k) clearance for its wireless lung sound measurement platform, RESP™
Strados Labs, a health technology developer of remote respiratory devices and software, today announced it has received FDA Class II 510(k) clearance for its first product, RESP™, a system for measuring, recording and analyzing lung sounds remotely across healthcare settings.
Onkos Surgical® continues its innovation in musculoskeletal oncology and complex orthopaedic reconstruction with the launch of the ELEOS™ Proximal Tibia with BioGrip™ technology
Onkos Surgical, Inc., an innovator in the field of musculoskeletal oncology and personalized orthopaedics, continues to deliver on its promise of commercializing innovative solutions with the launch of the new ELEOS Proximal Tibia with BioGrip technology.
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€7.4 Million in blended funding awarded to SepTec to develop and scale ground-breaking innovation
The #EICAccelerator results were released last week for the final (and most competitive ever!) cut-off of the new blended programme. SepTec Ltd is proud to announce that we were one of the 38 companies chosen as Europe’s most promising start-ups and SMEs by the European Innovation Council and was awarded €7.4 Million in blended funding to develop and scale up our ground-breaking innovation.
Avenda Health Receives FDA Clearance for their Focal Laser Ablation System
Avenda Health, a software and medical device company that spun out of UCLA, announced today that the Food and Drug Administration (FDA) has cleared their focal laser ablation system.
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Centerline Biomedical Kicks Off First Clinical Study of Intra-Operative Positioning System Technology
Centerline Biomedical, Inc. (Centerline) announced Tuesday the completion of the first surgical case in its MOTION clinical study of its innovative Intra-Operative Positioning System (IOPS™) surgical navigation platform.
FDA Awards Genetesis Breakthrough Device Designation for CardioFlux® Imaging Technology
Genetesis, Inc. announced today that its flagship product, CardioFlux®, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for the diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome.
Osteoporosis Prevention Product Wins FDA Breakthrough Device Designation (featuring Bone Health Technologies)
Bone Health Technologies, creator of the OsteoBoost Vibration Belt that promises to reduce the risk of osteoporosis, has been granted “Breakthrough Device”
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Avelas Receives FDA Breakthrough Therapy Designation for Pegloprastide (AVB-620) for Use During Breast Cancer Surgery
Avelas Biosciences, Inc., pioneering the field of intraoperative fluorescent cancer imaging, today announced that the company has received Breakthrough Therapy designation from the U.S.
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U.K. Invests $330M to Lead the World In Healthcare AI (featuring Kheiron Medical Technologies)
The year 2020 has undoubtedly provided those in healthcare and technology communities with multiple problems to solve. From enabling telemedicine at scale to creating and distributing an entirely new vaccine, the problems caused by the pandemic have required collaboration, investment and adoption at speed previously unseen in healthcare.
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Day Zero Diagnostics Wins $300K NIH Grant to Refine HAI Outbreak Analysis Service
Infectious disease startup Day Zero Diagnostics last week received a $300,000 grant from the National Institutes of Health to further develop its nanopore sequencing-based technology for the analysis of healthcare-associated infection (HAI) outbreaks.
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Conversations with Medtech Pioneers: MedTech Innovator’s 2020 Grand Prize Winner, Rhaeos
The largest global medtech-only accelerator, Medtech Innovator had over 1,000 applicants in 2020 and CEO, Paul Grand, and his team successfully pivoted in March 2020 to a virtual competition due to COVID.
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Safety and Efficacy of Intermittent Colonic Exoperistalsis Device to Treat Chronic Constipation: A Prospective Multicentric Clinical Trial, featuring MOWOOT
Chronic constipation is associated with various comorbidities and reduced quality of life. Current solutions, either pharmacological or invasive, show limited efficacy.
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Vectorious’ In-Heart Microcomputer Wins FDA Breakthrough Nod
Vectorious Medical Technologies today announced that the FDA has granted breakthrough device designation for the company’s left atrial pressure (LAP) monitoring device.
First Use of nView’s Novel 3D Imaging Technology in Pediatric Spine Surgery
Children’s National Hospital today performed the first surgical use of breakthrough medical imaging technology designed specifically for kids. The innovation, insta-3D™ imaging from company nView medical, is designed to make 3D images available in the operating room quickly and safely.
GT Medical Technologies Announces $16 Million Financing to Expand Availability of Targeted Therapy for Patients with Recurrent Brain Tumors
GT Medical Technologies, Inc., a company dedicated to improving the lives of patients with brain tumors, today announced it has raised $16 million in a Series B financing led by MVM Partners with participation from existing investors MedTech Venture Partners and BlueStone Venture Partners.
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New Diabetes ‘CGKM’ Sensor Will Monitor Both Glucose and Ketones (featuring PercuSense)
Glucose monitoring has come a long way in helping to reduce dangerous low blood sugars, but we haven’t seen the same capabilities for detecting and preventing high blood sugars that can lead to deadly Diabetic Ketoacidosis (DKA).
Explorer Surgical Launches Advanced Video for Remote Surgery
ExplORer Surgical, a Chicago-based startup that’s developed an interactive platform for surgeons, has launched a new suite of advanced audio and video capabilities to make remote support easier in the operating room (OR).
Subtle Medical Raises $12.2 Million in Series A Funding to Expand Its AI Imaging Solutions
Subtle Medical, a healthcare technology company, just announced its latest funding round – a $12.2 million Series A investment led by 3E Bioventures Capital with participation from Fusion Fund, Data Collective, Delta Capital, Tsingyuan Ventures and continued support from other seed investors.
Medable raises $91M for Its Clinical Trial Management Software
The clinical trial management software developer Medable has raised $91 million in a new round of financing as life sciences companies struggle with how to conduct the necessary validation studies of new drugs and devices in a pandemically challenged environment.
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Allotrope Medical Announces FDA Clearance of StimSite™
Allotrope Medical™ Inc., a company committed to advancing surgical safety and precision, today announced its FDA clearance of their device, StimSite. StimSite provides ob/gyns, general and colorectal surgeons the new ability to use their existing surgical instruments to help locate and identify ureters using electrical stimulation.
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X-COR Therapeutics, an Alira Health Ventures Portfolio Company, Closes Initial $2.6M Funding Round.
Alira Health (www.alirahealth.com), a leading international healthcare and life sciences advisory firm, congratulates X-COR Therapeutics for closing a $2.6M seed financing to continue developing its novel extracorporeal carbon dioxide removal device toward clinical trials.
CoapTech Awarded $1.6M from NIH for Pediatric Feeding Tube Placement Device
CoapTech Inc. announced today that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) within the National Institutes of Health (NIH) awarded CoapTech a two-year, $1.6M R44 Small Business Innovation Research (SBIR) Phase II grant on September 22, 2020 to finalize development of and trial its Pediatric PUMA-G System.
Nanowear Receives FDA 510(k) Clearance for SimpleSENSE, a Cloth-Based Wearable Remote Diagnostic Monitoring Platform
Nanowear www.nanowearinc.com, the leading connected-care and remote diagnostic platform, today announced it has received FDA Class II 510(k) clearance for a first-of-its-kind cloth-based diagnostic platform, SimpleSENSE.
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UCSF Rosenman Institute Announces Companies Chosen for “ADAPT” Program (featuring Vynca)
The UCSF Rosenman Institute announced today the startups selected in “UCSF Rosenman ADAPT,” a competitive global program for startup companies developing solutions to increase healthcare efficiency.
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SepTec Is One of the 6 Winners of the Eit Health UK-Ireland #Headstart €10,000 Top up Pitch
SepTec Ltd Is immensely proud to be one of the 6 winners of the EIT HEALTH UK-IRELAND #Headstart €10,000 top up pitch! This is a massive opportunity for the team and we are extremely grateful!
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Avisi Technologies: $1M NSF Grant
In 2017, Brandon Kao of Penn Engineering and Rui Jing Jiang and Adarsh Battu of the Wharton School devised a way to use a nanoscale material in the treatment of a form of glaucoma.
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PercuSense Announces Project with the University of Melbourne funded by The Helmsley Charitable Trust to Develop a Single Sensor Continuous Glucose and Ketone Monitor
PercuSense, an intelligent biosensor and digital health company, announced it has been awarded a $2.5 million program-related investment in the form of a loan from The Leona M.
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Robotic Catheterization for Mitral Valve Repair: Interview with Mark Barrish, CEO of Moray Medical
At present, mitral heart valve failure is treated through invasive surgery or via a transcatheter procedure called Transcatheter Edge-to-Edge Repair (TEER). However, this procedure is difficult to perform, potentially resulting in suboptimal outcomes in challenging cases and if done by inexperienced clinicians.
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Venari Medical Secures $5.3M Investment to Advance the Minimally Invasive Treatment of Chronic Venous Disease
Venari Medical, an innovative medical device company based in Galway (Ireland), recently raised $5.3 million (€4.5 million) in seed equity funding to accelerate the development of its ground-breaking BioVena™ device for the treatment of chronic venous disease.
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Sidekick Health Scores $20M for Its Gamified Digital Care Platform
Nordic digital therapeutics company, Sidekick Health, has closed a $20 million Series A led by pan-European VC Wellington Partners and healthcare focused VC Asabys Partners. Existing investors, Novator and Frumtak Ventures, also participated in the oversubscribed round.
FineHeart Achieves Milestone For Its Miniaturized Heart Pump Technology with Successful Completion of 30-Day Preclinical Study
FineHeart, SA, a preclinical-stage medical device company developing an Implantable Cardiac Output Management System (ICOMS) to address the unmet need of patients suffering from severe heart failure has announced the successful completion of a 30-day preclinical study.
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Lief Selected as the Winner of the Lyfebulb-Orexo Us Innovation Award in Substance Use Disorder
So honored and beyond excited to be selected as the winner of the Lyfebulb–Orexo US, Inc. Innovation Award in Substance Use disorder! It is truly humbling to work on a product than can touch so many lives, from anxiety to depression to substance use, and we’re incredibly grateful for this opportunity to help more patients.
Avenda Health Won 1st Place at Focal Therapy Gauntlet and Was Selected as the “Most Promising Ablative Technology.”
We competed in the Focal Therapy Gauntlet (https://lnkd.in/gPjzZXY) with 9 other cutting edge treatments for #prostate cancer at FOCAL 2020. Avenda Health won 1st place and was selected as the “Most Promising Ablative Technology.”
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FlowSense Monitors Hydrocephalus Shunts: Exclusive with Anna Lisa Somera, CEO of Rhaeos
Hydrocephalus patients have an excess of cerebrospinal fluid in the brain, which needs to be drained away through a ventricular shunt. However, these shunts regularly fail, with potentially life-threatening results.
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Admetsys Secures CE Mark Approval For PrecisionOne™ Automated Glycemic Control And Continuous Diagnostics System
Admetsys Corporation, a biomedical technology company specializing in critical care automation, announced today that it received European regulatory approval (CE Mark) for its flagship PrecisionOne™ automated glycemic control and continuous diagnostics system.
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Interventional Radiologists Report 100% Clinical Success Using Absorbable IVC Filters in First Human Study (featuring Adient Medical)
Implanting absorbable vena cava filters in patients with increased risk of pulmonary embolism resulted in a 100% clinical success rate, according to the results of a first in-human study published Tuesday.
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Savonix and Fujitsu Connected Technologies Limited Partner to Introduce Savonix Mobile App on Raku-Raku Smartphone F-42A
Savonix, a global leader in digital cognitive health testing, and Fujitsu Connected Technologies Limited (FCNT), one of the major smartphone manufacturers in Japan, unveiled Savonix Mobile–a digital cognitive testing app–on the Raku-Raku Smartphone F-42A.
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iDentical Raises $3.6M With its Novel Technology Designed to Address Dental Pain Point
COVID-19 might have temporarily closed dentist offices, but that hasn’t stopped iDentical from raising a healthy amount of cash for its innovative alternative to traditional dental implants.
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Vynca and Cerner Empower Patients and Clinicians to Honor End-Of-Life Care Decisions
Vynca, a national leader in advance care planning solutions, today announced a relationship with Cerner Corporation (Nasdaq: CERN), a global health care technology company, to help individuals and their families, caregivers and clinicians navigate the complex advance care planning process to ensure future care preferences are honored.
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Israeli pain monitoring co Medasense raises $18m
Israeli pain response monitoring company Medasense Biometrics Ltd. today announced that it has raised $18 million in a series C round from Spain’s Sabadell Asabys venture capital firm, Israeli family offices and returning investors Baxter Ventures, Olive Tree Ventures and LGL Capital.
Osso VR raises $14 million to bring virtual reality to surgical and medical device training
As remote work becomes the order of the day in the COVID-19 era, any tool that can bring training and education services to folks across industries is gaining a huge amount of investor interest — and that includes healthcare.
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Avisi Technologies Eyes Goal of Human Trials With $1M National Science Foundation Grant
RealLIST Startups 2020 honoree Avisi Technologies, maker of an ocular implant to treat glaucoma, is the recent recipient of a $1 million Small Business Innovation Research Phase II grant from the National Science Foundation (NSF) — funds cofounder Rui Jing Jiang said will go toward bringing the startup’s research to life in preclinical work.
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Exclusive: First full at-home COVID-19 test (featuring Gauss)
Gauss, a computer vision startup, and Cellex, a biotech company that works on diagnostics, are announcing the first rapid COVID-19 test that can be fully performed by people at home without involving a laboratory.
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Wireless EEG for Fast Prep and Easy Use: Q&A with Aswin Gunasekar, CEO of Zeto
Conn Hastings, Medgadget: Please give us an overview of conventional EEG devices, and their limitations.
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7D Surgical’s Largest Financing Round to Bolster Product Development, Expansion Plans
7D Surgical has completed its largest financing round to date, according to a Sept. 15 announcement.
Fibralign Announces CE Mark Approval for BioBridge
Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced that it has received CE mark for its first product, the BioBridge® Collagen Matrix.
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PhotoniCare Announces More Than $7M in Funding for Commercial Expansion of First-In-Class Ear Imaging Technology
PhotoniCare, Inc., a company dedicated to revolutionizing healthcare by providing physicians with better diagnostic tools, today announced an oversubscribed $5.2 million Series A financing led by i2E Management Company Inc., with co-investment from OSF Ventures, Sony Innovation Fund, and Dreampact Ventures.
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Miracor Medical Raises €24M in Funding
Miracor Medical SA, an Awans, Belgium-based provider of innovative solutions for the treatment of severe cardiac diseases, closed a €24M Series E round of financing.
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ODS Medical, Inc. closes a new financing round to further support product development diversification of applications
ODS Medical, Inc., a Montreal based medical technology company, is pleased to announce a new financing round to support product engineering and regulatory work.
CoapTech Raises $7M in Series B Funding Led by Hunniwell
CoapTech Inc (Baltimore, MD), a leading medical device start-up pioneering the world’s first and only ultrasound-based feeding tube placement system, announced today the closing of a Series B investment of $7 million led by Palo Alto-based medical device venture capital firm Hunniwell Lake Ventures.
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Sidekick Health wins the eHealth Award 2020
The eHealth Award is an annual award to Nordic small businesses that have an innovative eHealth solution or product that has shown benefits for patients, citizens, healthcare professionals or healthcare organisations.
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LensGen® Closes $10 Million Financing and Welcomes James V. Mazzo to its Board of Directors
LensGen, Inc., an ophthalmic medical device company and developer of Juvene®, a disruptive fluid-optic intraocular lens (IOL) for cataract and presbyopia treatment, announces the initial Closing of a $10 million of the $20 million Bridge Financing.
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Money Moves: 3 life science and health IT companies raise funds — and one goes public (featuring Strados Labs)
Strados Labs has been awarded a National Science Foundation (NSF)Phase I Small Business Innovation Research grant for nearly $225,000 to conduct research on its wearable platform for remote respiratory monitoring.
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Sentien Biotechnologies Announces Open IND in Phase 1/2 Trial of SBI-101 for Patients with COVID-19
Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application for the evaluation of Sentien’s lead asset, SBI-101, for the treatment of severe COVID-19.
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Oncodisc, Inc. Awarded Competitive Grant from the National Science Foundation to Develop Cancer Technology
Oncodisc, Inc. today announced that it is the recipient of a competitive National Science Foundation (NSF) Small Business Innovation Research (SBIR) grant award.
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HD Medical Awarded FDA Clearance For HD Steth
HD Medical, Inc. of Silicon Valley today announces that its flagship product, HD Steth, has received FDA clearance for all three product classification codes of DQD, DQC and DPS for Electronic Stethoscope, Phonocardiograph and Electrocardiograph combined into one device.
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Forest Devices Launches Collaboration With Alberta Health Services
Medical technology pioneer Forest Devices, Inc. (FDI) today announced a commitment to improve healthcare delivery for stroke patients in Alberta, forming a collaboration with Alberta Health Services (AHS) to evaluate and test technologies that can improve patient outcomes and health system performance by empowering emergency first responders to make informed decisions regarding care for stroke patients.
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SidekickHealth secures multimillion-dollar deal with Pfizer
Nordic digital therapeutics company SidekickHealth is partnering with pharma giant Pfizer to launch a digital therapeutics platform, in a deal thought to be worth more than $8 million.
Medable Partners With Datavant to Simplify Integration of Data Sources for Decentralized Clinical Trials
Medable Inc., the leading software provider for decentralized clinical trials, and Datavant, the leader in helping healthcare organizations safely connect their data, today announced a partnership that will help clinical trial teams easily integrate multiple data sources to accelerate decentralized trial design, recruitment and data management.
20 medical device startups you need to know
The medtech industry isn’t immune from COVID-19 troubles, but exciting innovation continues. These 20 medical device startups have grabbed our attention.
OrthoGrid Systems Partners with Osso VR
OrthoGrid specializes in live, intraoperative, AI-powered, radiographic assessment and alignment technologies for orthopedic surgery, with applications for hip arthroplasty, hip preservation, and trauma surgery.
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Chicagoland medical device company raises $15 million in Series B funding
Chicago Business Journal — A Chicagoland medical company that makes a device to make it easier for doctors to see in surgery said it’s raised $15 in a Series B funding round.
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First AR Spine Surgery Using Augmedics xvision Completed in U.S.
Augmedics’ xvision Spine System has been successfully used for the first time in a spinal fusion surgery in the United States. The system was used in a spinal surgery procedure by Johns Hopkins University surgeons.
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Western Ireland’s University Hospital Galway Leading Advanced Heart Failure Monitoring Clinical Trial
Cardiology-focused Investigators from University Hospital Galway complete a first-in-man clinical trial for a sensor that may help patients with heart failure stay out of the hospital.
LabCorp Launches Website to Connect Patients with COVID-19 Clinical Trials
BioSpace — Laboratory Corporation of America Holdings, or LabCorp, is one of the two largest clinical diagnostic laboratory companies in the U.S. The company announced its Covance drug development business was launching COVID-19 Clinical Trial Connect in the U.S.
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Bigfoot Biomedical raises $55m in Series C
MassDevice — Diabetes treatment tech company Bigfoot Biomedical announced today that it raised $55 million to close its Series C financing round.
Fibralign Announces Strategic Partnership With Terumo
Fibralign Corp., a Stanford spin-out developer of therapeutic biomedical devices, has announced today that it has executed a long term distributor agreement with Terumo Corporation to market and distribute the BioBridge® Collagen Matrix in Japan for treating and preventing secondary lymphedema.
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Rhaeos, Inc. Receives FDA Breakthrough Device Designation for FlowSense™ Noninvasive Thermal Sensor
Rhaeos, Inc. (Rhaeos), a private medical technology company focused on addressing a clinical unmet need in the care of patients with hydrocephalus, today announced its initial product, FlowSense™, a wireless, noninvasive flow sensor, has been granted Breakthrough Device Designation by the U.S.
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Arterys Raises $28 Million to Accelerate the Delivery of Medical AI to Practices Around the World
Arterys, a leading global medical imaging platform to deliver clinical AI products over the internet, just received its seventh USA FDA clearance and announced its latest round of funding — a $28 million Series C investment from a syndicate led by Benslie Investment Group and Temasek Holdings, with participation by Fosun, Revelation Partners, Emergent Medical Partners, and Varian Medical Systems.
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PercuSense Secures DoD Funds for Chemical Exposure Monitoring Tech Dev’t
PercuSense has received a multiyear, $4.6M contract from two Department of Defense organizations to build a continuous monitoring biosensor technology that will work to detect exposure to toxic chemicals.
Medtech Startup Promaxo Raises First Tranche of Series B-1 Funding
Launched in 2016, Promaxo plans to revolutionize healthcare with its MR imaging and robotic platform. Promaxo’s MRI is designed to be used in a standard physician’s office, without the need for extensive safety procedures or a dedicated infrastructure for housing and maintaining the unit.
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Neural Analytics aims robotic transcranial doppler at COVID-19 patients
Doctors are reporting a proliferation of dangerous blood clots in the lungs and other major organs of COVID-19 patients, raising the risk of stroke and other life-threatening complications.
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FDA greenlights ICU AI for predicting fatal COVID-19 complications
The company’s CLEWICU artificial intelligence software ingests a large range of patient data by linking to electronic medical records, connected medical devices and vital sign monitors, with no need for additional data entry by ICU staff.
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Bardy Diagnostics® Announces CE Mark Certification for 14-Day Carnation® Ambulatory Monitor (CAM®) Patch in Europe and Expansion of Home Enrollment Program Amidst COVID-19 Crisis
Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it received CE mark certification for the 14-Day version of the Carnation Ambulatory Monitor (“CAM”) patch, the industry’s only P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device.
Alleviant Medical completes $6.5m offering
Congestive heart failure treatment developer Alleviant Medical filed an SEC Form D to confirm the sale of $6.5 million in an equity offering.
PharmaJet and Abnova partner to develop and deliver COVID-19 mRNA Vaccine using Needle-free Injection technology
Abnova has established a comprehensive portfolio of fully integrated solutions to address the needs for responding to SARS-CoV-2, including a novel adjuvant that can further increase the effectiveness of their mRNA candidate.
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PyrAmes Is Granted Breakthrough Device Designation for Boppli, a Continuous, Non-Invasive Blood Pressure Monitoring System
PyrAmes Inc. is proud to announce that it has been granted Breakthrough Device Designation (BDD) from the FDA for Boppli, our novel continuous, non-invasive blood pressure (cNIBP) monitoring system intended for use in neonatal critical care settings.
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Houston’s Allotrope Medical wins 2020 Texas A&M New Ventures Competition
Innovation was on full display this week at the sixth annual Texas A&M New Ventures Competition (TNVC) hosted by the Texas A&M Engineering Experiment Station (TEES). Due to safety concerns amid the COVID-19 pandemic, organizers shifted the event to a virtual platform.
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Day Zero Diagnostics wins $6.2m from accelerator
MassDevice — Day Zero Diagnostics announced that it received an award of up to $6.2 million in non-dilutive funding from Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X).
Genetesis lands strategic investment to close $9.2M Series B
(TechOhio) – Genetesis Inc, a medical technology company that has developed non-invasive, biomagnetic CardioFluxTM imaging, today announced several important updates.
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Antibody testing for COVID-19 prepares for its closeup in bid to ease pandemic restrictions
As states in the U.S. move past the initial push for tests to identify active COVID-19 infections, antibody tests are ramping up quickly to aid in disease surveillance and return-to-work screenings.
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Louisville medical device company gets emergency FDA approval
Louisville-based Liberate Medical LLC received an emergency use authorization from the Food and Drug Administration to market its core product, VentFree, during the coronavirus crisis, Louisville Business First reports.
Medable Secures $25M Funding To Reduce Clinical Trial Timelines
(CrunchBase News) — Palo Alto, California startup Medable Inc. raised $25 million in funding led by GSR Ventures, to accelerate clinical drug development with digital technology.
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Onkos Surgical raises $7.6m
(Mass Device) — Surgical oncology device developer Onkos Surgical filed an SEC Form D to confirm the sale of nearly $7.6 million in equity.
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Baxter Reports First-Quarter 2020 Results
Baxter International Inc. (NYSE:BAX), a leading global medical products company, today reported results for the first quarter of 2020.
AtaCor Medical completes $25m Series B
(Mass Device) — Extracardiac temporary pacing technology developer AtaCor Medical announced today that it completed a $25 million Series B financing round.
TDK Ventures Invests in Biomagnetic Medical Imaging Company Genetesis
TDK Corporation (TSE:6762) announces that subsidiary TDK Ventures Inc. adds to its growing portfolio of companies with an investment in Genetesis, a world leader in non-invasive biomagnetic imaging.
Companies Launch New Framework to Accelerate COVID-19 Research; Streamlines Path for Diagnostics, Monitoring and Clinical Trials
Medable Inc. today announced a multi-company research framework to accelerate development of diagnostics and treatments for COVID-19, providing individuals fast access to participate in leading-edge research for diagnostics, health monitoring and interventional clinical trials.
This physician-founder is making a device to protect medical staff during intubation procedures
Dr. Steven Tropello is bringing experience and a network developed while building local startup CoapTech.
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Gauss Partners with Evive to Launch Mobile App for COVID-19 Testing and Research
Gauss, a leading developer of digital decision-support tools for the medical frontlines, in partnership with Evive, the leader in enterprise communications and benefits engagement, has today announced the nationwide release of Apollo, a free Apple iOS app and WebApp, to help increase safety and efficiency of drive-through COVID-19 screening and testing for patients and health workers.
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Hillel’s Tech Corner: Clues to the COVID-19 crisis
(The Jerusalem Post) — To say that these times are challenging would be a laughable understatement. This coronavirus pandemic is quickly becoming one of the most challenging times humanity has ever known. There are the obvious health tragedies of families being ripped apart.
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Carnation Ambulatory Monitor patch used to detect arrhythmias in COVID-19 patients
Bardy Diagnostics has announced that its Carnation Ambulatory Monitor (CAM) Patch has been chosen for use in protocols to measure QT Segments in COVID-19 patients who have been prescribed hydroxychloroquine (HCQ).
SilverCloud Health Raises $16M in Series B Funding
SilverCloud Health, a Boston, MA-based digital mental health platform, raised $16m in Series B funding.
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Nanomix Awarded BARDA Contract for Development of Rapid, Mobile, Point-of-Care Assays to Detect COVID-19 Infection
Tests designed to detect both active and past infections in less than 15 minutes, using handheld Nanomix eLab Analyzer
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Spire Health Helps Pulmonary, Critical Care & Sleep Disorders Institute of South Florida Remotely Monitor High Risk Patients in Fight Against Coronavirus
Spire Health and PCSI to Offer Innovative Home Monitoring Capabilities to Limit Patient Exposure and Identify Patients in Need of Extra Care
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OrthoPediatrics Corp. Announces Acquisition of ApiFix Ltd. with FDA-Approved Non-Fusion Scoliosis Technology
OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq:KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, is pleased to announce that it has acquired ApiFix Ltd.
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Selective endovascular cooling with TwinFlo catheter shows promise for neuroprotection in stroke patients
NeuroNews — Ron Solar (ThermopeutiX, San Diego, USA) and colleagues report in EuroIntervention that the TwinFlo catheter (ThermopeutiX), in pigs, was associated with rapid, selective, deep cerebral hypothermia.
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Bardy Diagnostics™ Announces Use of The Carnation Ambulatory Monitor Patch to Measure QT Segments in COVID-19 Patients Using Hydroxychloroquine
Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today that its Carnation Ambulatory Monitor (“CAM™”) Patch has been chosen for use in protocols to measure QT Segments in COVID-19 patients who have been prescribed Hydroxychloroquine (HCQ).
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Duo device for tricuspid repair records first successful use in humans
CroíValve has announced the successful first human use of its Duo Tricuspid Coaptation Valve technology for tricuspid repair. The company says the procedure was performed by an experienced heart team in St James’ University Hospital (Dublin, Ireland).
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Duo device for tricuspid repair records first successful use in humans
CroíValve has announced the successful first human use of its Duo Tricuspid Coaptation Valve technology for tricuspid repair. The company says the procedure was performed by an experienced heart team in St James’ University Hospital (Dublin, Ireland).
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Spry Health Launches New Service, Loop Signal, to Assist in Surge of COVID-19 Cases by Reducing Avoidable Hospital Visits and Improving Patient Monitoring at Home
Spry Health, a leader in health management technologies and remote patient monitoring, today announced the launch of Loop Signal, a new clinician-led monitoring service utilizing the company’s proprietary FDA-cleared (Class II) solution, the Loop System, to reduce avoidable hospital visits and to improve at home monitoring of patients confirmed, suspected, or at risk for COVID-19.
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Pristine Surgical completes $18 million capital raise
Pristine Surgical LLC, makers of the first fully-integrated, single-use visualization platform for rigid endoscopic surgical and diagnostic procedures, announced today that it completed its third round of investment capital raising.
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Zeto Raises Series A Funding to Accelerate Commercialization Efforts of its Easy Use Electroencephalography (EEG) Headset and Software Platform
Zeto, Inc., a privately held medical technology company that is transforming the Electroencephalography (EEG) experience for healthcare, today announced that it has raised $7.3 million in Series A financing led by Seraph Group and joined by Aphelion Capital, SV Tech Ventures and Shangbay Capital.
Subtle Medical Named to the 2020 CB Insights AI 100 List of Most Innovative Artificial Intelligence Startups
CB Insights today named Subtle Medical to the fourth annual AI 100 ranking, showcasing the 100 most promising private artificial intelligence companies in the world.
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Abreos gets Grant of 850 000 USD for monitoring of Crohns disease
Abreos Biosciences has been awarded funding for phase two of the “Personalized precision dosing of anti-TNF biological therapies” project by, among others, the National Institute of Health’s (NIH).
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ALPHASTROKE, A Better Way to Diagnose Strokes: Interview with CEO Matt Kesinger
MedGadget — Strokes affect nearly 800,000 Americans per year. One of the most important prognostic factors is the time from symptom onset to treatment.
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Endotronix begins heart failure study with Cordella Sensor
Digital health and medical technology firm Endotronix has recruited the first two patients in the PROACTIVE-HF pivotal trial of the Cordella pulmonary artery (PA) pressure sensor system.
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Endotronix begins heart failure study with Cordella Sensor
Digital health and medical technology firm Endotronix has recruited the first two patients in the PROACTIVE-HF pivotal trial of the Cordella pulmonary artery (PA) pressure sensor system.
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2Morrow Distributes Digital Health Programs Aimed at Smoking and Vaping Cessation on Walmart.com
2Morrow, Inc., a leader in pioneering evidence-based digital health solutions, is offering two digital nicotine addiction programs on Walmart.com including a smoking cessation program for all age groups and a vaping cessation program for teens and young adults.
Johnson & Johnson distributing 150+ VR headsets for joint reconstruction training — 6 insights
Becker’sSpineReview — Johnson & Johnson plans to distribute at least 150 virtual reality headsets to U.S. surgeons through a partnership with startup Osso VR, two executives from Johnson & Johnson Medical Devices Companies told MedCity News.
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CloudCath closes $12M for catheter-based treatment monitoring platform
MobiHealthNews — CloudCath, the maker of a remote monitoring platform for catheter-based treatments, has closed a $12 million Series A financing round.
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CloudCath closes $12M for catheter-based treatment monitoring platform
CloudCath, the maker of a remote monitoring platform for catheter-based treatments, has closed a $12 million Series A financing round. Capital Integral headlined the raise, which also saw investments from FundRx, The Capital Partnership, Coconut Tree Investments, Stanford University’s StartX Fund and other unnamed strategic and individual investors.
Randomized Trial of a Virtual Reality Tool to Teach Surgical Technique for Tibial Shaft Fracture Intramedullary Nailing
The following was shared by Justin Barad, CEO, Osso VR: I frequently get asked if using virtual reality for surgical training actually works. Well, I’m unbelievably excited to announce that UCLA Health ‘s study showing Osso VR boosting surgical performance by 230% has been published this month in the Journal of Surgical Education!
Onkos Surgical® announces the launch of GenVie™, a novel Magnesium Bone Scaffolding technology
Onkos Surgical® is pleased to announce the launch of GenVie™ Magnesium Bone Scaffold, a novel biologic technology that further expands Onkos’ reach in complex limb salvage procedures.
First large-scale polio vaccination campaign using PharmaJet intradermal Needle-free Injector
The campaign, sponsored by the World Health Organization as part of its polio eradication efforts, vaccinated 500,000 children, aged 4 – 59 months, over a one-week period in early 2019.
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Japanese Regulators Approve Non-Invasive Angiography Technology
CathWorks has received Japanese Ministry of Health, Labour and Welfare (MHLW) approval of The CathWorks FFRangio System, a non-invasive diagnostic technology that is used at the time of a routine angiography.
Magnetocardiography IDs chest pain in 90 seconds
A 90-second chest scan could be a game-changer for triaging patients who present to the emergency department with undiagnosed chest pain, according to research out of Detroit.
GT Medical Wins Expanded Indication for GammaTile Therapy
“We are pleased to offer GammaTile Therapy to patients who are newly diagnosed with malignant brain tumors, in addition to patients with recurrent brain tumors,”
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Start-up makes breakthrough in treatment for chronic venous disease
Chronic venous disease (CVD) affects one in four adults and covers a range of conditions from enlarged varicose veins to distressing and uncomfortable open sores known as leg ulcers.
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Bardy Diagnostics™ Announces Commercial Launch of the 14-Day Carnation Ambulatory Monitor (CAM) Patch
Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today the commercial launch of the 14-Day version of the Carnation Ambulatory Monitor (“CAM™”), the industry’s only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device, following recent clearance by the FDA.
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SoundBite Receives FDA 510(k) Clearance of the SoundBite Crossing System – Peripheral
SoundBite Medical Solutions Inc. (SBMS) today announces it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the SoundBite™ Crossing System, a unique active wire technology for use in the treatment of peripheral chronic total occlusions (CTOs).
Onkos Surgical Partners With Integrum
Onkos Surgical, Inc. a leader in the field of musculoskeletal oncology and personalized orthopaedics announced today a multi-year agreement with Integrum AB (INTEG B: Nasdaq First North exchange).
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Bigfoot Biomedical announces $45M Series C tranche, expands partnership with Abbott
Bigfoot Biomedical, a diabetes startup looking to automate insulin delivery via a connected insulin pen, has kicked off its Series C round with an initial tranche of $45 million.
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FDA clears PhotoniCare’s handheld OCT scanner for checking ear infections
PhotoniCare received FDA 510(k) clearance for its hand-held, noninvasive imaging scope that allows physicians to check for fluids deep behind the eardrum—one of the main signs of childhood ear infections.
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Durham healthcare startup NeuroTronik raise nearly $119,000 in debt
NeuroTronik, a healthcare startup out of Durham, has raised nearly $119,000 in debt, according to a SEC filing today.
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Augmedics launches its Xvision Spine AR nav system in U.S.
Augmedics announced today that it won FDA 510(k) clearance for and initiated the U.S. launch of its Xvision Spine augmented reality guidance system to be used in surgery.
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Vynca and PatientPing Announce Partnership
Vynca, the nation’s leading advance care planning technology solution and PatientPing, the nation’s leading care collaboration platform, today announced a partnership to surface real-time advance care planning information to providers across the care continuum.
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NATO Announces Sana Health as winner of the NATO Innovation Challenge to Develop Device to Optimize Performance of Soldiers in Combat
The modern war-fighter faces increasing cognitive demands, exponentially more information, and a greater need for mental resilience than ever before. Sana, a device that uses audiovisual neuromodulation to produce a deep state of relaxation and optimize recovery, was chosen as the most promising technology to help address this growing need.
SilverCloud Health Selected for Express Scripts’ Industry-First Digital Health Formulary for Mental and Behavioral Health
SilverCloud Health, one of the leading digital mental health platforms, today announced that Express Scripts, the largest independent manager of pharmacy benefits in the United States, will include SilverCloud’s evidenced-based digital mental health platform on its new digital health formulary in 2020.
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CathWorks FFRangio System Receives Regulatory Approval in Japan
The CathWorks FFRangio System is also commercially available in the United States and Europe. It is non-invasive and performed intra-procedurally during coronary angiography without adding additional clinical risk or per procedure costs.
Neural Analytics Enrolls First Patient With Its Next-Generation Lucid Robotic System
Dr. Iwuchukwu and the Ochsner Clinical Foundation are the first to clinically evaluate the new version of the Lucid Robotic System. The first generation of the Lucid Robotic System was cleared by the U.S.
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Sudbury med-tech company counts down to product launch
A Sudbury startup medical device company is about six months away from commercializing its product after winning a prestigious award in Boston this fall.
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Empirical Spine completes enrollment in LimiFlex pivotal trial
Empirical Spine announced that it completed enrollment in the investigational arm of its U.S. investigative device exemption trial studying its LimiFlex therapy for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis.
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Arterys Launches the First Viewer-Based AI Marketplace for Medical Imaging, Fueling Open Innovation
Arterys, the San Francisco–based pioneering AI startup known for its internet platform for medical imaging, will debut its open innovation platform, the Arterys Marketplace, at RSNA 2019.
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How GE Healthcare is investing in MedTech Innovation
GE Healthcare (NYSE:GE) appears to be taking the “throw it against the wall and see what sticks” approach when it comes to medtech innovation.
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ApiFix Receives FDA Approval to Commercialize MID-C System for Motion-Preserving Deformity Treatment of Progressive Idiopathic Scoliosis in Adolescents
ApiFix Ltd., a leading motion-preservation scoliosis correction company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) via a Humanitarian Device Exemption (HDE) to market the Minimally Invasive Deformity Correction (MID-C) system for the treatment of progressive adolescent idiopathic scoliosis (AIS).
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PhotoniCare Takes Home First Place at HealthTECH Startup Competition
Illinois Ventures portfolio company PhotoniCare won first place and $25,000 at the 7th Annual Insight Product Development 2019 HealthTECH Startup Competition.
Medable Powers University of Connecticut Department of Kinesiology and Hartford Healthcare Virtual Study on Statin-Related Adverse Events
The collaborative digital study is intended to prospectively monitor participant response to statin medications via an app, and notify clinicians and patients when the patient should stop or start their medication based on presenting symptoms collected via electronic patient-reported outcomes (ePROs).
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Top UT Inventions and Innovations of 2019
Dell Seton Medical Center’s John Uecker performs about 350 laparoscopic surgeries a year and was frustrated by constantly having to stop surgery to clean the camera lens.
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Highmark Health to Test Virtual Cardiac Rehabilitation Program
Pittsburgh-based Highmark Health, the nation’s second-largest integrated healthcare network based on revenue, is testing a virtual cardiac rehabilitation solution for delivering cardiac rehab remotely to patients with heart disease.
Osso VR Wins SBIR Contract by US Air Force
Osso VR has been awarded the US Air Force Small Business Innovation Research (SBIR) contract. The first phase of the project includes a feasibility study to determine VR surgical training’s benefits and application within the Air Force.
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Endotronix unveils positive data from SIRONA trial of Cordella system
Endotronix’ Cordella heart failure system is intended to help patients suffering from chronic heart failure to stay out of the hospital
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EMS stroke triage platform edges out fellow digital cardiac care startups at AHA Scientific Sessions 2019 pitch contest
A half dozen digital health startups went head to head this weekend in a pitch contest hosted by the American Heart Association
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Laurent Duvernay-Tardif, Kansas City Chiefs Offensive Attendant and McGill University Faculty of Medicine graduate, joins the genealogy team of Emovi inc.
Montreal, Quebec (November 14, 2019) Emovi, Inc., announced today the signing of a multi-year agreement with Kansas City Chiefs offensive guard Laurent Duvernay-Tardif, MDCM, to support the knowledge transfer to health care professionals and patients regarding genealogy with the KneeKG system, a new knee evaluation modality.
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Proximo Medical Expands Portfolio with PEDRA™ Technology
Proximo Medical, LLC today announced a partnership with PEDRA™ Technology, a Singapore based medical device innovator focused on the treatment of peripheral artery disease (PAD), for marketing and commercialization of its perfusion monitoring technology.
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MedAware Systems Named Top Start Up by The Tech Tribune
MedAware Systems announced today that it has been named a top start up by The Tech Tribune. Companies were evaluated based on four criteria: Revenue potential, Leadership team, Brand/product traction, and Competitive landscape.
Biotech’s leading lights recognised at annual Awards
Industry Excellence Awards were announced today at the AusBiotech 2019 national conference in Melbourne. The Awards recognise innovative companies and individuals leading the way in Australia’s world-class biotechnology, medical technology and healthcare sectors.
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Liberate Medical, a local medical device maker, gets sales green light
A Louisville area medical device company has received clearance to sell its core product on the open market.
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Bardy Diagnostics™ Wins the Remote Monitoring in Arrhythmias Digital Health Pitch Session at European Society of Cardiology Congress 2019 and Presents at UK Heart Rhythm Congress 2019
Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that it was selected as winner of the “Remote Monitoring in Arrhythmias”
Microsoft and SilverCloud collaboration to leverage AI for mental health
The treatment of mental health conditions appears to have received a boost with a recently announced research collaboration between digital mental health company SilverCloud Health and Microsoft Research. The partnership was designed to further step up the former’s online offering with artificial intelligence.
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Nanowear and Sana Health win UCSF digital health
The University of California San Francisco’s Health Hub, an innovation and startup studio, announced on Oct. 11 the winners of its inaugural Digital Health Awards.
Nanowear awarded Best Cardiovascular Digital Diagnostic at the 1st Annual UCSF Digital Health Awards
Nanowear was excitedly (and unexpectedly) awarded Best Cardiovascular Digital Diagnostic at the 1st Annual UCSF Digital Health Awards (Nanowear award and acceptance speech here ) This inaugural event is not a pitch competition, but rather a 4-month-evaluation of over 500 companies by 250+ industry judges (providers, payers, VCs, researchers, etc), who selected finalists and awardees in 13 different categories across Digital Health.
Subtle Medical Receives FDA 510(k) Clearance for AI-Powered SubtleMR™
Subtle Medical, a healthcare technology company focused on improving the quality, efficiency, and accessibility of medical imaging, announced today 510(k) clearance from the U.S.
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Mansueto, Polsky part of $25 million medical-device investment
Endotronix raised another $25 million to conduct late-stage trials of an implantable device to help doctors better monitor cardiac patients and detect problems before they lead to heart failure.
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Department of Health launches new app for teens and young adults who vape
The Washington State Department of Health is announcing a new smartphone app to help teens and young adults quit vaping. Developed collaboratively with 2Morrow Inc., the app is available for free to Washingtonians at doh.wa.gov/quit and is accessible via smartphone, tablet, laptop and desktop computer.
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Children’s National names 6 winners of NICU device competition
Six winners were named in a pitch competition for medical devices designed to improve care in the neonatal intensive care unit at the seventh annual Pediatric Device Innovation Symposium, hosted by Washington, D.C.-based Children’s National Hospital.
3D Systems Gains FDA Clearance for VSP Orthopaedics 3D Surgical Pre-Planning Solution
3D printing company 3D Systems has just announced 510(k) clearance from the Food and Drug Administration (FDA) for their VSP Orthopaedics solution. This development will further increase solutions offered in their VSP approach for orthopaedics, which has already played a role in the treatment of over 120,000 patients—over the past 25 years.
Johnson & Johnson wants to bring VR to doctors-in-training worldwide
The Johnson & Johnson Institute said that training surgeons using Oculus virtual reality headsets is paying off in big ways, and it hopes that such training will be available worldwide to all surgeons in the future.
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Emovi, Inc. Receives $4.8 Million in Financial Assistance from Quebec Government to Support Expansion in the United States
Emovi, Inc. announced today they have received the support of the Quebec government with financial assistance of $4.8 million bringing their total funding for 2019 over $20 million.
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Facebook is said to be spending more than $500 million to buy a company working to let you control computers with your mind
Facebook is acquiring the maker of an electronic wristband that it says will allow people to share photos on its social network, click a button on their computer’s mouse, and perform other computing tasks simply by thinking about it.
Access Vascular Awarded Breakthrough Technology Agreement with Premier
Access Vascular, Inc. has been awarded a group purchasing agreement for a Breakthrough Technology contract with Premier. Effective September 1, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for the HydroPICC™ peripherally inserted central catheter which is indicated for reduced thrombus accumulation.
Neural networks and feature-based machine learning: The evolution of applications in Healthcare and Medtech
Nanowear, a New York-based connected care and companion diagnostic platform built on FDA-cleared nanotechnology, is delivering a new standard for remote patient monitoring.
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The Conference Forum Announces Tasso Wins DPharm Idol Disrupt 2019 for Patient-Centric Blood Sampling Kits
Tasso was announced the winner of DPharm Idol Disrupt at the 9th annual DPharm: Disrupting Innovations to Advance Clinical Trials Conference. Tasso has a service that provides patient centric blood-sampling kits for use by participants in clinical trials.
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Houston medical device company launches is product in the U.S. and hires new exec
A Houston company is changing the game when it comes to early bleed detection, and now the company can provide its life-saving service to the United States.
NIH Awards Subtle Medical, Inc. $1.6 Million Grant to Improve Safety of MRI Exams By Reducing Gadolinium Dose Using AI
Subtle Medical, a privately-held healthcare technology company focused on improving the quality, efficiency, and safety of medical imaging, announced that it received a Fast-Track Small Business Innovation Research (SBIR) grant valued up to $1.6 million, contingent on deliverables, from the National Institutes of Health (NIH).
CoapTech and Fidmi Medical to Collaborate on Groundbreaking G-Tube Systems
CoapTech LLC (Baltimore, MD) and Fidmi Medical, Ltd. (Caesarea, Israel) announced today that they will be collaborating on bringing to market a set of next-generation products for the initial placement and long-term maintenance of gastrostomy tubes (G-tubes).
Osso VR Partners with Sawbones
Osso VR, a validated virtual reality (VR) surgical training platform, is partnering with Sawbones, the originator of “hands-on” orthopedic and medical workshop models worldwide.
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Grant for Greenville med device firm is a first in Eastern NC
RFPi, a Greenville medical device company, has landed the first Phase II Small Business Technology Transfer grant ever awarded by the National Institutes of Health in Eastern North Carolina or with East Carolina University as the academic research partner.
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CroíValve Secures €4M in Additional Funding to Initiate Clinical Trials
€4 million in additional financing has been secured by CroíValve, a high potential start-up (HPSU) supported by Enterprise Ireland developing a treatment for tricuspid regurgitation (TR).
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Pfizer launches pilot with home robot Mabu to study patient response to AI
Pharmaceutical giant Pfizer today announced plans to launch a one-year pilot program with robotics company Catalia Health, maker of Mabu, a home robot that coaches patients on health and prescription drugs.
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FDA Clears 14-Day Carnation Ambulatory Monitor Patch
Seattle-based Bardy Diagnostics, Inc., a provider of ambulatory cardiac monitoring technologies and custom data solutions, announces that it has received 510(k) clearance from the U.S.
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Houston Business Journal announced that Texas Halo Fund invested $150,000 in TMCx03 alumni company, Allotrope Medical
Houston Business Journal announced that Texas Halo Fund invested $150,000 in TMCx03 alumni company, Allotrope Medical! We’re lucky to have Allotrope’s CEO & FounderAlbert Huang, MD, as our Innovation Strategist.
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Redox Announces Free Support for USCDI on FHIR
Redox, the leading cloud interoperability platform, announced today that the company has expanded further support for open standards including U.S. Core Data for Interoperability (USCDI) on the FHIR standard.
Bone Solutions, Onkos ink private label deal
Bone Solutions said today that it entered into a private label licensing agreement with Onkos Surgical for its OsteoCrete bone void-filling technology.
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Miracor secures FDA breakthrough status for its heart attack device
Belgian devicemaker Miracor Medical received a breakthrough designation from the FDA for its treatment designed to limit the damage of a heart attack.
Results support feasibility of entirely extracardiac, minimally invasive, temporary pacing system
New results support the feasibility of an entirely extracardiac pacing method in a heterogeneous patient population, using a minimally invasive, parasternal delivery approach, with adequate sensing and thresholds suited for temporary pacing.
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Gore’s Silicon Valley Innovation Center Fosters Collaboration At Newly Opened Prototyping Lab
W. L. Gore & Associates (Gore), continues to contribute its more than 60 years of material science expertise to Silicon Valley’s startup community through its Santa Clara based Innovation Center.
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Virtual and augmented reality can save lives by improving surgeons’ training
Rapid advances in the development of medical devices in the 21st century are contributing to healthier lives, but bring with them a new challenge: teaching clinicians how to use these often-complicated technologies.
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Patientory launching $5.3 million Series A Raise and Joins Oregon Enterprise Blockchain Venture Studio
Patientory Inc., a global population healthcare solution company, is the newest member of Oregon Enterprise Blockchain Venture Studio, a program designed to support startups that drive blockchain innovation and solve critical business challenges.
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Startup Respirix raises $1.3m
Heart failure detection startup Respirix has reported raising $1.3 million, according to a securities filing.
Medable Joins the American Heart Association’s Center for Health Technology & Innovation Innovators Network to Enhance Digital Real-World Evidence Patient Registries Powering a Human Heart Digitome
Medable Inc., the leading provider of digitally enabled and data-driven clinical trials, will join the American Heart Association’s Center for Health Technology & Innovation (the Center) Innovators Network.
Medical Technology Startup Promaxo Closes $8M Round of Financing
Promaxo, the pioneer in the development of in-office MRI, announced today that it has closed $8M round of financing from a group of super angels and strategic investors.
Osso VR Expands Its Reach, Shares Study Results
Virtual reality surgical training solution Osso VR is already impacting reality. A just-released study conducted by UCLA’s David Geffen School of Medicine shows that the surgical performance of Osso VR users “improved by 230% and their speed was 20% faster,”
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GNA Biosolutions Closes $13.5M Series C Financing Round Backed by a US/EU consortium
GNA Biosolutions GmbH, a molecular diagnostics company based in Germany, announced today that it has completed a $13.5M round of financing.
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Bigfoot Biomedical Announces Partnership with Allegheny Health Network to Advance Innovative Solution for People with Diabetes
Bigfoot Biomedical, Inc., and Allegheny Health Network (AHN) – a Highmark Health company – announced today a collaboration to further advance Bigfoot Biomedical’s first-in-kind data-driven solutions for optimizing the dosing and delivery of insulin for people with diabetes.
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Israeli companies chosen for MedTech Innovator Showcase
Medasense for pain management and Vectorious for heart-failure monitoring were among 50 companies selected from a field of 800 applicants.
Nanowear Announces Clinical Launch of NanoSENSE, a Heart Failure Management and Alert Diagnostic Validation Study
Nanowear, the leading nanotechnology-based connected-care and remote monitoring platform, today announced the clinical launch of NanoSENSE, a Heart Failure Management and Alert Diagnostic Validation Study.
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Endotronix Enrolls First Patient in SIRONA II CE Mark Trial
Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced enrollment of the first patient in its prospective, multi-center, SIRONA II trial, in Europe.
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Centerline Biomedical Receives FDA 510(k) Clearance for Intra-Operative Positioning System
A non-radiation-based surgical navigation system for minimally invasive surgery, IOPS leverages anatomical mapping algorithms and electromagnetic tracking technology to provide three-dimensional color visualization and guidance in real time during endovascular procedures.
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Emovi Announces U.S. Commercial Launch of KneeKG In-Clinic Device
KneeKG is the first device to enable doctors to accurately assess patients’ knees in 3D while the patient is moving and weight-bearing. In contrast to static information from x-ray and magnetic resonance imaging (MRI), KneeKG quickly identifies the functional causes linked to knee pain, allowing doctors to better target treatments instead of the current process of elimination method, revolutionizing current knee assessment.
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Day Zero Diagnostics Awarded Phase I SBIR Grant for Algorithm Development
Day Zero Diagnostics (DZD) said today it has received a Phase I Small Business Innovation Research (SBIR) award from the NIH’s National Institute of Allergies and Infectious Disease (NIAID) intended to fund the development of an algorithm to automate the determination of infection relatedness in suspected hospital-acquired infection (HAI) outbreaks.
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AblaCare Announces Series A Financing of €10 Million by Sofinnova Partners for Innovative Infertility Treatment and Appoints Jodie Fam as CEO
AblaCare, a medical device company dedicated to transforming women’s health and fertility care, announced today that it has raised €10 million in Series A financing from Sofinnova Partners. The company also announced the appointment of seasoned medical device executive Jodie Fam as CEO.
Dr. Amit Vohra Awarded the “Top 100 Leaders in Health Care” at IFAH, Vegas 2019
Amit Vohra was conferred with the “Top 100 Leaders in Health Care” award for his significant contributions towards the health care sector at IFAH 2019, held at Caesars Palace, Vegas on June 18-20, 2019.
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Spinal Singularity Awarded Research Grant From the Department of Defense
Spinal Singularity announced today that the company was awarded over $3.6 million by the U.S. Army Medical Research and Material Command (USAMRMC), Congressionally Directed Medical Research Programs (CDMRP), during FY18 for the Spinal Cord Injury Research Program (SCIRP).
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CLEW to be featured in a new episode of “Information Matrix”, with Laurence Fishburne
An upcoming episode of the award-winning program “Information Matrix” hosted by successful actor and philanthropist Laurence Fishburne, will feature new content on the use of AI-Machine Learning in the treatment of critically ill patients.
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The Winner of The Top North American Wearable 2019 goes to Zeto
#WTUS19 is no doubt a hotspot for leading #wearable #innovators. And among the best there is the top. The Winner of The Top North American Wearable 2019 goes to @ZetoEEG!! Congratulations for the advanced solution and a team of great efforts!! #IOTWTIWC
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Potrero Medical receives CE mark for the Accuryn® Monitoring System
We have exciting news today…..we received the CE mark for the Accuryn® Monitoring System!!! Looking forward to introducing our technology to Europe. #medicaldevices #medicaldevice #medicine #healthcare #cemarking #medtech #europeanunion
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Venture capital fund invests in health startup
A local health system’s venture capital fund has invested $1 million in an out-of-state startup.
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Bardy Diagnostics Wins MedTech Breakthrough Award for Best New Diagnostic Technology
Bardy Diagnostics Inc. announced that its Carnation Ambulatory Monitor (CAM) was recognized with the “Best New Diagnostic Technology” award in the 2019 MedTech Breakthrough Awards Program.
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NESTcc announces new real-world evidence Test-Cases solicited from medical device community
The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announced twelve new Test-Cases which leverage Real-World Evidence (RWE) and address key priorities for medical device stakeholders.
Medable and Synexus Announce Partnership to Launch Telemedicine Solution to Improve Patient Retention and Engagement in Data-Driven Virtual Clinical Trials
Medable Inc. a leading provider of innovative clinical trial technologies that provide data-driven and digitally enabled clinical trials, and Synexus, the leading global network of dedicated research sites, announced today the launch of Medable Telemedicine, a solution that enables site sponsors to conduct secure, HIPAA-compliant video consultations with clinical study participants.
Medical Technology Startup Promaxo Named TiE50 Award Winner at TiEcon
Medical technology startup Promaxo is excited to announce that it has been selected as a 2019 TiE50 Winner in the prestigious TiE50 Awards Program. This awards competition, now in its tenth year, is a program of TiECon, the world’s largest conference for tech entrepreneurs.
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SFC Fluidics Partners with PercuSense and Diabeloop to Improve Diabetes Care
SFC Fluidics, Inc. (SFC) has partnered with two companies, Diabeloop SA and PercuSense, Inc., as part of the Industry Development and Discovery Partnership that was awarded to SFC Fluidics in 2018 by JDRF.
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Spire Health announces first of its kind study to identify predictors of COPD exacerbations through 24/7 continuous respiratory remote monitoring
Study using novel continuous ambulatory respiratory sensors to assess adherence among COPD patients and identify digital biomarkers preceding COPD exacerbations
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Imec develops a wearable fetal ECG monitor for pregnant moms
Now that electrocardiogram (ECG) monitors have become comfortably wearable for adults, enabling more frequent heart monitoring than was possible outside of medical settings, researchers are preparing to take the technology to the next level.
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PhotoniCare Inc. Announces Initiation of a Multi-Site Registered Clinical Study in Patients Undergoing Surgery for Chronic Middle Ear Infection
PhotoniCare Inc., a medical device company headquartered in Champaign, Illinois, announces successful initiation of a multi-site registered clinical study to evaluate the imaging capabilities and image analysis performance of the PhotoniCare TOMi Scope.
Neural Analytics Announces First Site Initiation, First Subject Enrollment in the CODEX Study
Neural Analytics Inc., a medical robotics company developing and commercializing technologies to measure and track brain health, has announced the first site initiation and first subjects enrolled into the CODEX Study, a prospective, single arm multi-center safety and technical feasibility study utilizing an investigational iteration of the Lucid Robotic System (Lucid M1 Transcranial Doppler Ultrasound System and NeuralBot System), at the Ochsner Clinical Foundation in New Orleans, La.“There is a growing interest in the diagnostic potential of measuring the dynamic changes of cerebral blood flow in different neurological conditions.
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Harvard Business School New Venture Competition Finale 2019 Recap
Harvard Business School’s Klarman Hall was host to the 22nd annual New Venture Competition. Presenting awards at the event were Jodi Gernon, the Director of the Arthur Rock Center for Entrepreneurship; Matt Segneri, the Director of the Social Enterprise Initiative; and Mary-Helen Black, the Director of HBS Alumni Clubs & Associations.
ExplORer Surgical raises $5M for its cloud-based platform for the operating room
The Chicago-based startup’s tool, which is focused on boosting communication and coordination between all members of the surgical team, aims to reduce errors and improve OR efficiency.
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FDA grants breakthrough status to preeclampsia device
Our free newsletter will bring you the latest news & trends in medical technology. From FDA activity to R&D breakthroughs, from inception to manufacturing, we’ll deliver the industry intel you need to know.
This man invented a spell-checker for prescriptions, and it’s saving lives
A few years ago, a doctor prescribed Singulair, a standard asthma medication, to a 9-year-old boy. At least that’s what the doctor thought he prescribed.
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Beyonce Had Pre-Eclampsia. Doctors Have New Ways to Detect and Treat It.
The FDA is looking into a device and revolutionary pee test that could help stave the leading cause of maternal and fetal deaths.
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Acting as the Data Integrator Between Hospitals and Digital Health Apps Brings Redox $33M
Investors have forked over $33 million in a new round of funding for Redox, hoping that the company can execute on its bid to serve as the link between healthcare providers and the technology companies bringing new digital services to market.
Medable Awarded $3.5M in SBIR Fast-Track Grants from the National Cancer Institute to Develop Digital Platforms to Improve Patient Care
Medable Inc. a leading provider of the end-to-end platform for digitally enabled and data-driven clinical trials, today announced it has been awarded two Fast-Track Small Business Innovation (SBIR) grants from the National Cancer Institute (NCI).
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Innoblative’s SIRA™ RFA Electrosurgical Device Receives FDA Clearance
Innoblative Designs, Inc. (Innoblative), a private medical device company committed to developing next generation, advanced-energy surgical solutions, announced it received U.S.
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SafeHeal obtains CE-mark for Colovac, its novel endoluminal bypass sheath
SafeHeal, a leading innovator in the field of digestive surgery, announces today that its unique Colovac bypass sheath has received the CE-mark.
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UK patient first to be treated with clot-removing device
A UK patient has become the first in the world to be treated using a new clot-removing device.
Prospective Pilot Shows AI to Have Higher Accuracy in Detecting Cervical Cancer Than Lab Tests
MobileODT’s CDS Algorithm Shows Impressive Results in First Real-Time Application of AVE for Cervical Cancer Screening
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FDA clears Spry Health’s remote monitoring wearable for COPD patients
The Loop System, a continuous remote monitor developed by Palo Alto-based startup Spry Health, received 510(k) clearance from the FDA last Friday, according to an update to the agency’s databasethat was confirmed by the company.
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Irish medical devices company CroíValve raises 3.2 Million
Early-stage medical devices company CroíValve has raised €3.2 million oversubscribed seed financing round.
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Vision and passion drive successful entrepreneurs
Successful entrepreneurs have vision. They are driven by passion and possibilities. It is a privilege to watch them in action. A case in point is Dr. Ryan Dennis, CEO of Linear Health Sciences, a medical device company whose safety valve technology will change the way patients are connected to their treatments.
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Abreos Biosciences Announces Research Collaboration with FDA-CDER
Abreos Biosciences, a San Diego-based biotech company and leader in precision dosing of biological therapeutics, is pleased to announce a research collaboration with the FDA’s Center for Drug Evaluation and Research (CDER) to develop several methods to measure the drug concentration of biologic drugs based on the Veritope™ platform.
Genetesis CardioFlux™ platform receives FDA 510(k) clearance
(Mason, OH March 22, 2019 8 am) Genetesis, a medical technology company focused on using biomagnetic imaging to enable rapid, noninvasive and accurate chest pain triage, has received FDA 510(k) clearance for its cardiac imaging platform.
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Vixiar Medical Nabs $1.5M to Expand Hand-Held Devices for Cardiac Monitoring
Vixiar Medical, Inc., a Baltimore, Maryland-based company dedicated to the development of non-invasive devices and systems for monitoring cardiopulmonary diseases has raised $1.5 million from new and existing investors.
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Machines Treating Patients? It’s Already Happening
Rayfield Byrd knows when it’s time to wake up every morning. The 68-year-old Oakland, Cal., resident hears a voice from the living room offering a cheery good morning. Except Byrd lives alone.
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Conavi Medical Announces Health Canada Approval of Novasight Hybrid System for Visualization During Coronary Angioplasty Procedures
Conavi Medical Inc. is pleased to announce that it has received a Health Canada Medical Device License for the Novasight Hybrid System. This patented technology is the only clinical system that enables simultaneous imaging of coronary arteries with both intravascular ultrasound (IVUS) and optical coherence tomography (OCT), and was invented at Sunnybrook Research Institute.
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Startup’s health-monitoring technology breathes new life into digital healthcare, featuring Spire
After successful retail launches with Apple and clearance from national health insurers, Spire Health’s wearable medical device is poised to impact clinical care across a variety of applications.
Osso VR to Showcase First Virtual Reality Training Module for Robotics with Smith & Nephew’s NAVIO Surgical System
Osso VR, a validated virtual reality (VR) surgical training platform, has announced a first-of-its-kind VR training module for Smith & Nephew’s NAVIOTM Surgical System. The system is being demonstrated at the American Academy of Orthopaedic Surgeons (AAOS) 2019 Annual Meeting March 12–16.
Mobile phone technology to screen, help treat college students, featuring SilverCloud
A research team led by Washington University School of Medicine in St. Louis has received a five-year, $3.8 million grant to evaluate the use of smartphones in treating psychiatric problems that are common among college students.
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L’Oréal Announces Partnership With Microbial Genomics Leader uBiome To Advance New Research Into The Skin Microbiome
L’Oréal today announced a partnership between its Technology Incubator and Silicon Valley-based uBiome, the leader in microbial genomics, to continue its longtime research into skin microbiome—the trillions of bacteria that live on, and provide an important barrier to, your skin.
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Tasso Gets $6M For Device That Lets Users Self-Collect Blood Samples
Tasso, a Seattle-based startup that is developing an at-home blood sample collection device, announced Tuesday it has raised $6.1 million from investors. The new money will support its effort to launch sales of the device, Tasso OnDemand, in the coming months, and to add staff, Tasso says.
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FDA Grants Saranas De Novo Designation for the Early Bird Bleed Monitoring System
Saranas Inc., a medical device company with innovative technology for real-time detection and monitoring of internal bleeding during endovascular procedures, today announced that it has been granted de novo classification by the U.S. Food and Drug Administration (FDA) for the Early Bird Bleed Monitoring System.
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Emovi is accelerating its growth through a 15M$ Series C investment led by TVM Capital Life Science
Emovi announced today its partnership with TVM Capital Life Science and co-investors StandUp Ventures and Desjardins Capital to support its global commercial activities. This 15M$ Series C investment is combined with other capital for a total of 20M$.
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PhotoniCare, Inc. Signs Exclusive Distribution Agreement with Adachi Co., LTD to Commercialize the TOMi Scope in Japan
PhotoniCare, Inc., a medical device company headquartered in Champaign, Illinois, has signed an exclusive distribution agreement with Adachi Co., LTD, (Osaka, Japan) to commercialize PhotoniCare’s TOMi™ Scope device throughout Japan.
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How the future of minimally invasive surgery could revolutionize healthcare, featuring Centerline Biomedical
Minimally invasive surgery promised faster recoveries, less pain, less ‘collateral’ damage to healthy parts of the body and fewer complications, thus reducing costs and improving outcomes.
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Tech Kentucky businesses awarded $2.18M in SBIR/STTR match funding, featuring Liberate Medical
Ten high-tech Kentucky companies will receive $2.18 million in state matching funds to promote growth and job creation in high-paying research and technological fields, from disease research to water treatment.
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General Electric : Picturing the Path to Precision Health and Better Care
One-third of hospitalized sepsis patients die, according to research published in 2017 in JAMA: The Journal of the American Medical Association.
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Redox To Power EHR Integration in Microsoft Teams Through FHIR
Redox today announced that it is integrating with Microsoft Teams to enable secure, bidirectional data exchange with electronic health record (EHR) software at provider organizations using the FHIR (Fast Healthcare Interoperability Resources) standard.
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CathWorks FFRangio System Receives FDA Clearance
The CathWorks FFRangio System quickly and precisely delivers the objective FFR guidance needed to optimize PCI therapy decisions. FFRangio is derived from routine X-Rays acquired during a diagnostic angiogram procedure, is non-invasive and performed intra-procedurally during coronary angiography, eliminating additional clinical risk, time and cost associated with invasive FFR.
Osso VR Awarded More Than $200,000 from the National Science Foundation to Advance its Surgical Skill Assessment Platform
Osso VR Awarded More Than $200,000 from the National Science Foundation to Advance its Surgical Skill Assessment Platform
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CathWorks Announces Completion of $30 Million Financing
CathWorks announced the completion of a $30 million Series C financing round led by Deerfield Management.
GT Medical Technologies Announces $10 Million Financing to Support Launch of Targeted Therapy for Patients with Recurrent Brain Tumors
“GT MedTech’s mission is in line with our investment goal of supporting innovative technologies that address unmet needs in vital disease areas,” said Radu Cautis, partner and managing director of MedTech Venture Partners.
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FDA Designates VentFree Muscle Stimulator a Breakthrough Device
The US Food and Drug Administration (FDA) has awarded Breakthrough Therapy Designation to the VentFree muscle stimulator. The device is being developed to prevent atrophy in breathing muscles and reduce the number of days of ventilator support in adult patients who need mechanical ventilation.
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These Goggles Act Like Surgical X-Ray Specs
Augmedics’ surgical “X-ray specs” are really an augmented-reality headset that superimposes CT scans and other images over a patient’s body, helping surgeons map an operation without looking away.
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Multi-Spectral Device Images Blood Flow and Perfusion
A new device reveals real-time blood flow and perfusion in vascular structures and critical tissues during surgery.
Machine Learning Algorithm Detects Cervical Cancer
A novel colposcope uses an automated visual evaluation (AVE) algorithm to detect cervical cancer from even a single image.
MobileODT deploys EVA System in first large scale AI pilot for cervical cancer screenings
MobileODT is rolling out its Enhanced Visual Assessment (EVA) System in what it’s calling the first large-scale pilot program to examine the use of augmented intelligence (AI) for cervical cancer screenings.
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FDA OKs Greenville firm to produce surgical device
A Greenville company has received clearance from the U.S. Food and Drug Administration to begin marketing a hi-tech medical imaging device it says has the potential to reduce surgical complications, the company announced this week.
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SafeHeal Completes First-in-Human Clinical Study of Endoluminal Bypass Sheath
SafeHeal, an innovator in the field of digestive surgery, has concluded its first-in-human clinical study for its novel Colovac bypass sheath in patients undergoing colorectal surgery.
An Observational Study of Deep Learning and Automated Evaluation of Cervical Images for Cancer Screening
A population-based longitudinal cohort of 9406 women ages 18–94 years in Guanacaste, Costa Rica was followed for 7 years (1993–2000), incorporating multiple cervical screening methods and histopathologic confirmation of precancers.
MobileODT and partners to launch first wide-scale deployment of AI screening for Cervical Cancer
MobileODT, developer of the Enhanced Visual Assessment (EVA) System, will partner with Genworks and Apollo Hospitals to deliver its FDA-cleared smart mobile colposcope. The project will perform the first large-scale pilot of Augmented Intelligence (AI) for use in the screening of cervical cancer.
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Vetex Medical Announces First Patient Treated in FIM Study of Deep Vein Thrombosis Treatment Designed to Remove Wall-Adherent Clot in Single Session, Without Thrombolytic Drugs
Vetex™ Medical Ltd. announced that the first patient has been treated in the VETEX (Venous Thrombus Extraction) Study, a first-in-man, multicenter study of the Vetex™ Thrombectomy Catheter.
Say goodbye to ‘what if’ in surgery — Dr. Jonathan Schoenecker on how VR helps orthopedic surgeons train for the OR
Surgical training technology company Osso VR launched its first pediatric orthopedic procedure module in partnership with the Pediatric Orthopaedic Society of North America.
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Irish Medical Device Start-up Curing Irregular Heart Rhythms Wins the Prestigious ICI Innovation Award
An Irish medical device’s company, AuriGen Medical has won the prestigious Global Innovation Award at the ICI conference in Tel Aviv, Israel. ICI is the premier International Conference for Innovations in Cardiovascular Systems.
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AMP3D Announces Partnership With Premier
Advanced Medical Predictive Devices, Diagnostics, and Displays Inc. (AMP3D) announced today that it has partnered with Premier Inc., a leading healthcare improvement company, to bring AMP3D’s Continuous Monitoring of Event Trajectories (CoMET®) predictive analytics platform to Premier’s clinical surveillance portfolio.
Lightpoint Medical shines with £5M investment
Lightpoint Medical has secured a £5 million round from backers including Envestors and Cambridge Capital Group. The startup, which develops intraoperative molecular imaging and sensing technology, plans to use the funds to boost commercial growth.
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Tech Council names finalists for annual awards, featuring GreenLight Medical
The Nashville Technology Council has announced the finalists for the 10th Annual NTC Awards. The organization will next month name winners in 14 categories, which each have three finalists. They are:
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Practice Makes Perfect…Virtually
The North American Spine Society (NASS) 2018 event that took place in September seemed quite similar to the ones I’ve attended during previous years. The overwhelming focus (on the expo floor anyway) was on technologies and solutions involved in spinal fusion procedures.
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Linear Health Sciences Enters Exclusive Distribution Agreement with Alliance Medical for Orchid SRV
Linear Health Sciences today announced that it has entered into an exclusive distribution agreement with Alliance Medical, a leading distributor for emerging medical technologies, for the Orchid Safety Release Valve™, a patient safety device designed to help prevent intravenous (IV) catheter dislodgement.
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Neural Analytics Adds $10M for Robot-Assisted Brain Ultrasound
Neural Analytics yesterday reported raising nearly $10 million in for the robot-assisted brain ultrasound device it’s developing.
Osso VR expands VR training Into pediatric orthopedic simulations, partners with the POSNA
Osso VR, a leading virtual reality surgical training technology company, announces today its first module for pediatric orthopedic procedures, launched in partnership with the Pediatric Orthopaedic Society of North America (POSNA).
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Sana Health Leads MedTech Innovators
This is a ground-breaking time in medical technology, and nowhere are the breakthroughs more evident than at the MedTech Innovator Showcase & Accelerator event.
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Square 1 Bank Announces Credit Facility to Zenflow
Square 1 Bank, a division of Pacific Western Bank, today announced that it has provided a $5 million credit facility to new client Zenflow, a privately-held urologic medical device company. Proceeds from the facility will support short-term and long-term growth initiatives.
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SafeHeal Reports Positive Results from Clinical Study of Colovac Device
French medical device company SafeHeal has reported positive results from a clinical study conducted for its Colovac bypass sheath in patients undergoing colorectal surgery.
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Using Artificial Intelligence To Fix Healthcare, featuring Catalia Health
The healthcare industry should be using Artificial Intelligence (AI) to a far greater degree than at present, but progress has been painfully slow. The same factors that make the healthcare system so attractive to AI developers – fragmented or non-existent data repositories, outdated computer systemsand doctor shortages – are the same things that have stopped AI from providing the gains that should be created.
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VerteCore Wins $500,000 Grand Prize At Accelerate Michigan Innovation Competition
VerteCore, a startup that has developed affordable, mobile decompression for instant spine relief, won Tuesday night the $500,000 grand prize at the Accelerate Michigan Innovation Competition, while GreenMark Biomedical Inc. and Shoptelligence took second and third prizes, respectively.
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5 Award-Winning Medical Device Innovations for Unmet Needs, featuring Sana Health
There are many factors innovators in medtech share. They all seek to offer elegant and novel technologies. They often take advantage of smart, artificial intelligence (AI) and machine learning advances.
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Eximis Surgical Secures $7.5 Million in Financing
Eximis Surgical, Inc. today announced it has secured $7.5 million in financing led by Questa Capital, with participation from Venture Investors. Eximis Surgical is developing a transformational surgical platform for the removal of large specimens through small laparoscopic incisions.
LaunchPad SBDC #MTIF2018 Winner, featuring AtaCor Medical
Thank you to everyone who came out to #MTIF2018! Here are some highlights of the 2 day conference. Our LaunchPad SBDC People’s Choice Award winner went to Evoke Neuroscience, and Our LaunchPad SBDC #MTIF2018 Winner went to AtaCor Medical, Inc.! Hope to see you next year at #MTIF2019 on Oct. 28-29 in Newport Beach!
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U.Va. Predictive Monitoring Systems Improve Patient Care, featuring MedAware
After piloting the new technology at the University’s NICU, the University partnered with other hospitals throughout the country, expanding the project to nine NICUs nationwide with the help of funding from the National Institutes of Health and Medical Predictive Science Corporation.
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Conavi Medical and Japan Lifeline Advance Japanese Sales Strategy of Novasight Hybrid Intravascular Imaging System
ConaviTM Medical Inc. is pleased to announce that Japan Lifeline has submitted an application for the regulatory approval of the Novasight HybridTM intravascular imaging system in Japan.
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Arterys Introduces First Complete AI- and Cloud-powered Solution for Most Challenging Medical Imaging Analysis Workflow
Cardio AI(MR) Web-based image analysis solution leverages power of deep learning and cloud supercomputing for improved radiologist efficiency and rapid analysis of Cardiac MR images
Making Digital Delivery For Mental Health Improve Engagement and Outcomes with Ken Cahill, CEO at SilverCloud Health
Hey Outcomes Rocket friends, thanks for tuning in to the podcast once again. As a leader in health care, you have big ideas great products, a story to tell, and are looking for ways to improve your reach and scale your business.
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CLEW Medical leverages AI to predict patient complications
An Israeli startup is working to integrate artificial intelligence and predictive analytics into the clinical workflow.
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Greenlight Medical selected as finalists for the 2018 NEXT Awards
Built on the belief that big ideas and the entrepreneurs behind them deserve to be celebrated, the award show will raise a glass to all rebels, visionaries, and game changers accelerating Middle Tennessee’s economy.
New technology for sexual assault victims launched at Penn Highlands Dubois
A technology new to Pennsylvania that’s enhancing care for sexual assault victims launched in Clearfield County Wednesday.
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Patientory – Innovation to Transformation – Forging the Path to Consumer-directed Health
Beta User Survey Results Report The May 31, 2018 Inaugural Patientory Summit featured a VIP Event sponsored by Patientory, Inc. during which the Beta test began for version one of the Patientory DApp. Event highlights here: https://youtu.be/Ipt12OzMpLA
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Test to Monitor Tysabri Levels in Relapsing MS Patients, moNATor by Abreos Biosciences, Available in US
Abreos Biosciences announced the U.S. launch of moNATor, a laboratory-developed test that can help physicians monitor the levels of Tysabri (natalizumab) in patients with multiple sclerosis (MS).
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Spinal Singularity touts grant, new sites for Connected Cath trial
Advanced catheter developer Spinal Singularity said yesterday it received a grant from the Triumph Foundation it plans to use to support upcoming clinical trials of its Connected Catheter, and said that it has added a number of new locations to its current trial of the device.
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Augmedics Begins First-in-Human Clinical Trial of xvision-spine (XVS) Augmented-Reality Surgical Navigation System
Augmedics has begun a first-in-human clinical trial of its xvision-spine (XVS) augmented-reality surgical navigation system at Sheba Tel Hashomer Medical Center and Asaf Harofeh Medical Center, in Israel.
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GreenLight Medical Partner to Simplify Medical Technology Procurement, Reinforce Compliance, Safety
symplr®, a leading provider of Software as a Service (SaaS) based healthcare compliance and credentialing solutions, and GreenLight Medical, a leading provider of hospital value analysis software for the new product introduction process, today announced a partnership creating an end-to-end vendor management solution for the healthcare industry.
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Mighty Oak Medical receives FDA clearance for new 3D-printed navigation guide: 3 notes
Mighty Oak Medical received FDA 510(k) clearance for its patient-specific, 3D-printed S2AI Guide for sacroiliac fixation in complex spinal reconstruction.
PharmaJet, Mundipharma team up to boost access to needle-free drug-delivery systems
PharmaJet and Mundipharma have inked an exclusive partnership to market and distribute PharmaJet’s Tropis and Stratis needle-free drug-delivery devices to more than 120 markets around the world.
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Three NC Companies in Elite Medical Technology Program
Three North Carolina companies joined the prestigious list of participants in the 2018 MedTech Innovator Accelerator and Showcase programs. The Los Angeles-based non-profit is a global competition and accelerator for medical device, digital health and diagnostic companies.
FDA clears IsoRay’s and GT’s cesium-131 based brachytherapy
With FDA clearance now in the bag, IsoRay Inc. is prepping for the inclusion of its cesium-131 seed-based brachytherapy option in the launch of GT Medical Technologies Inc.’s GammaTile solution for the treatment of recurrent brain tumors.
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US Army, Medical Technology Enterprise Consortium Collaborate with Los Angeles-based Accelerator
There is currently a major push to streamline the acquisition process and to better engage and partner with private industry in an effort to place cutting-edge technology quickly into the hands of the Warfighter.
IsoRay wins FDA nod for GammaTile brain tumor treatment
IsoRay (NYSE:ISR) said today it won FDA 510(k) clearance for its GammaTile brachytherapy technology designed for treating recurrent brain tumors.
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Lab To Showcase Technology – Emovi
Smart Health Innovation Lab https://smarthealthinnovationlab.com, a market adoption accelerator for healthcare technologies located in Pennsylvania, opened their first state-of-the-art facility to showcase the innovative technologies that the lab plans to market by establishing a 12 week certification program.
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Lab To Showcase Technology
Smart Health Innovation Lab https://smarthealthinnovationlab.com, a market adoption accelerator for healthcare technologies located in Pennsylvania, opened their first state-of-the-art facility to showcase the innovative technologies that the lab plans to market by establishing a 12 week certification program.
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Skip Capital and AirTree Ventures invest US $6.5M in MetaOptima
MetaOptima Technology Inc. has raised US $6.5 million recently from Australian venture firms, Skip Capital and AirTree Ventures.
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CoLabs Raises $4 Million, Launches Inaugural Software
AI software startup CoLabs acquired $4 million in seed-stage funding and unveiled its inaugural product, IntelAgree. Early investors in CoLabs include business leaders who supported the founders’ previous SaaS venture, eStaff365.
Neural Analytics Inc. Receives CE Mark for Robotic Ultrasound System
Medical robotics company Neural Analytics Inc. announced that it received CE Mark for its NeuralBot System, a robotic assistance technology which automatically adjusts orientation and position of its ultrasound products under the guidance of a healthcare professional.
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Delighted to be awarded €50k to help further develop our novel technology.
Delighted to be awarded €50k to help further develop our novel technology. Thanks to @EITHealth for their ongoing support. #2018HeadstartFinal
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Healthcare Accelerator Selects Six Startups for 2018 Program
Winrock International, Arkansas Heart Hospital, the University of Arkansas for Medical Sciences (UAMS) and BioVentures today announced the six companies selected to participate in the 2018 Health InnovatAR healthcare accelerator program, which is supported in part through a grant from the Arkansas Economic Development Commission.
‘Shark Tank’ billionaire Mark Cuban boosts investment in Cincinnati startup
Genetesis, a Mason startup that’s developing a medical imaging device that could benefit patients with heart problems, raised $7.5 million in a Series A round of funding from a group of investors that includes CincyTech and billionaire Mark Cuban of the TV show “Shark Tank.”
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CROIVALVE: Solution for Tricuspid Regurgitation Supports the Native Valve
Thanks to transcatheter aortic valve replacement (TAVR), many patients with heart valve disease have a new lease on life. That success is spilling over into mitral and tricuspid heart valve disease, which are both active areas of medical device innovation.
Neural Analytics Wins Federal Approval for Robotics Tech
Neural Analytics Inc., a medical device company based in Rancho Park, announced it has cleared a federal hurdle for a robotic system to assist with ultrasound in diagnosing brain trauma.
Access Vascular raises $2m
Access Vascular has raised $1.9 million in a new round of equity financing, according to an SEC filing posted this week.
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Riding the Start-Up Roller Coaster: What It’s Really Like to Be a Healthcare Entrepreneur
It’s a way of life that IntuiTap Medical CEO and co-founder Jessica Traver, 27, has become accustomed to since starting her company two years ago, which is focused on providing a game-changing solution to a common, and often painful, procedure: the spinal tap.
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Trayt debuts mobile app to track and help treat autism, ADHD
Trayt, a Redwood City, California-based data analytics company, has released a mobile application designed to help diagnose, track and treat patients with autism, ADHD and other neurodevelopmental brain disorders.
Avenda Health Receives $3.3 Million Investment
Avenda Health Inc., a biomedical device company based in Santa Monica, has closed a funding round of $3.3 million, according to a securities filing released April 11.
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Johnson & Johnson acquires C-SATS, a University of Washington spinout that grades surgeons
Johnson & Johnson today announced the acquisition of C-SATS, a Seattle startup that uses technology to facilitate performance reviews for surgeons.
Congestive heart failure device dev Alleviant Medical raises $1m
Alleviant Medical has raised $1.1 million in a new round of debt and options financing, according to an SEC filing posted this week.
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2Morrow adds chronic pain management to its mobile behavior therapy offerings
As opioid abuse continues to make impact in the US, more and more tech-driven answers to the drug crisis are springing up that aim to reduce patients’ reliance on prescription opioids.
FDA clears Access Vascular’s HydroPICC catheter
Access Vascular said today that its HydroPICC catheter has won 510(k) clearance from the FDA.
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SafeHeal Starts First-in-Human and CE-Mark Clinical Study of Endoluminal Bypass Sheath
SafeHeal, developer of the Colovac device, has enrolled the first five patients in its CE mark study. The Colovac device is a unique endoluminal bypass sheath placed in the colon following rectal resection, aimed at significantly improving the recovery of patients after colorectal surgery without the need for an ostomy.
PharmaJet, Genexine Partner for DNA Vaccines
Under the terms of the agreement, Genexine will use both the PharmaJet Stratis® and Tropis® devices in their Phase 1 and IIa human clinical studies. The agreement also includes provision for potential expansion to include Phase III studies and commercialization.
Google Developers Launchpad Studio welcomes more machine learning healthcare startups
We’re excited to announce the three new startups joining Launchpad Studio, our 6-month mentorship program tailored to help applied-machine learning startups build great products using the most advanced tools and technologies available.
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Zenflow raises $31m in Series A
Urology medical device maker Zenflow said today it closed a $31.4 million Series A round of financing to support the development of minimally invasive devices designed to treat obstructive urinary symptoms related to benign prostatic hyperplasia.
MedAware Systems Launches Comprehensive Apheresis Research Database
(PR.com)– MedAware Systems, Inc. announced today it is launching the world’s most comprehensive database of evidence on Apheresis, available through its SOHInfo™ division.
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Linear Health Sciences Announces Issuance of First US Patent
Linear Health Sciences today announced that the United States Patent and Trademark Office has issued the company’s first patent related to its flagship product, the Orchid Safety Release Valve™, a patient safety device designed to help prevent intravenous (IV) catheter dislodgement.
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Adhesys Medical gets CE mark for its topical skin adhesive for surgical use
Adhesys Medical, a surgical adhesive company, said it has received a CE mark for its Mar-Cutis Flix topical skin adhesive for surgical use.
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Day Zero Diagnostics: New Diagnostic Rapidly Identifies The Resistance Profile of Bacteria, Enabling Targeted Therapy Sooner
At the 2017 meeting of AdvaMed, the medical device industry’s advocacy organization, young start-up Day Zero Diagnostics was chosen as this year’s MedTech Innovator Global Competition winner.
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Taglich Brothers Initiates Nexeon Medsystems Inc.
Nexeon MedSystems Inc., headquartered in Dallas, Texas, is a medical device company developing a neurostimulator technology platform for the treatment of disorders through the electrical stimulation of neural tissues.
Accenture HealthTech Innovation Challenge Names Nanowear as Innovation Champion
More than 700 startups from around the world participated in the Accenture HealthTech Innovation Challenge that culminated on January 8th at the Startup Health Festival in San Francisco—part of the 36th annual J.P.
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IntuiTap closes $1.6M and forms strategic partnership
So excited to announce the close of our $1.6M round including investments from @thepinkceiling & @ionispharma! 2018 is off to a great start!
CROWDFUNDING: The 5 most successful crowdfunding campaigns in 2017
2017 was a banner year for crowdfunding campaigns. Here are five of the most successful crowdfunding campaigns last year that you need to know about.
Nanowear and The Secant Group announce exclusive supply chain partnership for scaled manufacturing of proprietary cloth-based nanosensor technology
Nanowear, the leader in cloth-based diagnostic monitoring nanosensor technology, today announced that it has entered into an exclusive, worldwide supply-chain partnership agreement with The Secant Group for scaled manufacturing and production of its medical-grade cloth-based nanosensor technology.
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Miracor closes $30m Series D
Miracor Medical Systems said today it closed a $30.2 million (EU €25 million) round of funding as part of Series D financing round with funds slated to support further development and commercialization of its PiCSO impulse system, and announced it is moving its headquarters from Austria to Belgium.
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Genomic Expression Receives $4.2M Grant to Validate Its OneRNA™ Liquid-Biopsy Platform in Bladder Cancer
The OneRNA4Bladder project aims to save lives and halve the cost of care for bladder-cancer treatment. Bladder cancer is the most expensive cancer to treat due to expensive diagnostic procedures and ineffective drugs resulting in a recurrence rate of 70%.
Denver’s Digital Health Boom
Medical care is no longer confined to the doctor’s office. Or even, sometimes, to an actual doctor. That iPhone in your pocket now has the capability to diagnose your cough, answer insurance questions, and get you pregnant…or at least help the process along.
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Cloud-based platform enables use of AI on medical images
The Food and Drug Administration has approved Arterys’ web-based imaging analytics platform, which marries cloud-based supercomputing and artificial intelligence, for clinical use.
Virtual Reality Makes for Better-Trained Surgeons
Some medical technologies can require hundreds of uses before a surgeon becomes proficient with them. Typical surgeon training involves working with cadavers, but doing this only allows trainees one, maybe two, sessions’ worth of experience.
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Linear Health Sciences Announces Additional Funding of $1.5 Million for Orchid Safety Release Valve
Linear Health Sciences today announced additional investment funding of $1.538 million, bringing total company financing to nearly $3 million. Linear Health Sciences is the developer of the Orchid Safety Release Valve (SRV)™ and other safety solutions for medical tubing.
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Smart-home tech might help older adults live independently longer
For an octogenarian with arthritic knees, a voice-controlled light switch could ease the pain of having to stand and walk just to illuminate a room.
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Nexeon’s neurotechnology in the fight against our aging bodies
We haven’t even come close to solving the problem of an aging population, so the tech sector is stepping in.
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AUM Cardiovascular Wins Gold in Best in Biz Awards 2017
AUM Cardiovascular has been named a gold winner in Best New Product of the Year – Healthcare in Best in Biz Awards, the only independent business awards program judged each year by prominent editors and reporters from top-tier publications in North America.
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Catalia Health draws another $4M in early funding
San Francisco-based patient engagement startup Catalia Health has announced an additional $4 million in pre-Series A funding from Ion Pacific and other investors.
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Arterys Completes Series B to accelerate product commercialization
Arterys Inc., a privately-held company leading the transition to cloud infrastructure and artificial intelligence in medical imaging, today announced the close of its $30M Series B financing round.
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50 Millennial Entrepreneurs Driving The Future of Tech in Europe
Imagine how important every second is when you have a heart attack, or consider the implications of a world run entirely on renewable energy. If you thought Blockchain technology would only impact finance; think again.
Texas Medical Center Announces $25 Million TMC Venture Fund
The Texas Medical Center, the largest medical complex in the world, today announced the TMC Venture Fund, a $25 million initiative designed to support technologies and early-stage companies to flourish in Houston’s health care ecosystem and further the TMC’s mission to advance health, education and research.
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Vyaire Medical Acquires Revolutionary Medical Devices, Inc.
Vyaire Medical, Inc., the healthcare industry’s dedicated “breathing company,” today announced it has acquired Revolutionary Medical Devices, Inc. (RMD), of Tucson, Ariz., a maker of innovative products for airway management, focused on significantly improving patient outcomes.
The Netherlands Cancer Institute Awarded Funding To Apply Molecular Imaging Technology To Prostate Cancer Surgery
The Netherlands Cancer Institute (NKI) announced today that it has received funding from the Dutch Cancer Society (KWF Kankerbestrijding) to test whether a novel molecular imaging technology can guide prostate cancer surgery.
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Allotrope Medical: A Simple Solution for Protecting the Ureter During Surgery
Albert Huang, MD, has always been an inventor. Growing up, he would tinker with cars and motorcycles and rebuild old audio equipment, he says, and that desire to fix things is why he chose general surgery among all medical specialties.
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Augmedics Secures $8.3 Million in Series A Funding for Augmented-Reality Surgical Visualization System
Augmedics, a developer of an augmented-reality (AR) surgical visualization system, has secured $8.3 million in Series A funding. Led by Davos, Switzerland-based AO Invest, which is fully funded by the non-profit AO Foundation, as well as Israeli Innovation Authority, Terra Venture Partners and other undisclosed investors.
Explorer Surgical lands $3 million more for operating room software
New Venture Challenge alum ExplORer Surgical, which makes software for surgical teams to use in the operating room, has raised $3 million, the company announced Tuesday.
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Eximis Surgical: Filling a Gap in Laparoscopic Tissue Removal
In June 2017, early-stage start-up Eximis Surgical LLC was the winner of a $25,000 award as the top company in the value category of the Medtech Innovator Competition.
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Tueo Health Oversubscribes Seed Round to Support Clinical Study and Growth
Tueo Health, a digital health start-up company that has developed a unique solution for monitoring and managing pediatric asthma, has closed $1.1 million in seed round funding. The seed financing was led by Launchpad Digital Health, with participation from Plug and Play, and other strategic angel investors.
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Vixiar Medical Raises $1.5M in Seed Financing
Vixiar Medical, Inc., an Annapolis, MD-based company dedicated to the development of non-invasive devices and systems for monitoring cardiopulmonary diseases, raised over $1.5m in seed financing.
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Shark Tank Meets Spine Start Up VerteCore!
While most of the talk this summer has been about shark sightings and attacks along our beaches and Olympic swimmer Michael Phelps’s race against the great white shark on the Discovery channel, there are some entrepreneurs who are quietly preparing to go head to head with a different group of sharks in the upcoming season of ABC’s Shark Tank which is scheduled to return in the fall.
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Selio Medical Wins UK-Ireland HeadStart/Proof-of-Concept Awards
Seven winners from the UK and Ireland were chosen to receive funding when EIT Health UK-Ireland held its HeadStart/Proof-of-Concept finals pitch competition on 19 July at Oxford University.
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MobileODT Secures $6.8M Series B Funding led by OrbiMed
Today, MobileODT announced it has raised an additional $6.825 million in a Series B fundraising round led by OrbiMed Advisors – a leading healthcare venture fund. Previous investors Tristel plc. also participated in the round. MobileODT has raised over $13 million to date.
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Spry Health Lands $5.5M to Fund Commercialization of Clinical-Grade Wearable
Spry Health, a Palo Alto, CA-based provider of remote patient monitoring solutions has raised $5.5 million in Series A funding led by Grove Ventures with participation from the Stanford-StartX Fund.
Osso VR Gets $2M to Train Surgeons in Virtual Operating Rooms
Osso VR, a startup looking to disrupt the surgical device training space with virtual reality, has raised $2 million in seed funding in a round led by Signalfire, with participation from Anorak Ventures.
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Precision Dosing Leader Abreos Biosciences Announces New Investment Round
Abreos Biosciences, a San Diego-based biotech company and a leader in the precision dosing of biological therapeutics, is pleased to announce that it has completed a new investment round. The funding came from existing investors as well as new investor TLP Investment Partners LLC and its affiliates.
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Atlanta-based Patientory raises $7.2 million in three days
Atlanta-based cybersecurity startup Patientory raised $7.2 million in three days from 1,728 individual purchasers.
Tech Toys and Tools That Excite the Top Entrepreneurs
Everybody has their favourite app, gadget or new technology that can make life easier, work more productive, and the future that much more exciting, and entrepreneurs are no different.
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Houston-area company wins $50K top prize at Texas A&M New Ventures Competition
A Houston-based medical device company took the top prize Thursday at the third annual Texas A&M New Ventures Competition.
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INBRACE Unveils World’s Most Advanced Fully Invisible Braces
INBRACE (http://myinbrace.com), the most advanced technology ever used to straighten teeth and perfect a patient’s smile, was publicly displayed for the first time during the American Association of Orthodontists Conference in front of a capacity crowd at EvoNexus (http://evonexus.org) in San Diego, California.
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Catalia Health Gets $2.5M to Improve Medication Adherence with a Social Robot
Catalia Health, which makes an AI-powered patient engagement robot called Mabu, has raised $2.5 million in a new round led by Khosla Ventures. Additional investments came from new investors NewGen Capital and Macnica Ventures and existing investors Q Venture Partners Limited, InnoLinks Ventures, Abstract by Flight.VC, DeNA and Lucky Capital.
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Madorra Captures First Prize at OEN’s 2017 Angel Oregon Showcase
Madorra treats vaginal dryness without hormones for the 32 million women who are currently suffering in silence. The company offers a simple, non-invasive, easy-to-use device that empowers women suffering from vaginal dryness to improve their sexual wellness.
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NeuroTronik Closes on a $23.1M Series B
NeuroTronik Limited and NeuroTronik, Inc. today announced closing on a $23.1 million Series B Preferred Stock Financing, tranched in line with project plan milestones.
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Adhesys Medical acquired by The Grunenthal Group
We are very excited to announce the great news that Adhesys Medical, our MedTech Innovator 2016 Execution Award Winner, has been acquired by The Grunenthal Group. You can read the details below from the press release announcing the acquisition. Congratulations to Alex Schueller and the team at Adhesys!
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Dr. Cory Kidd, Founder & CEO of Catalia Health Interviewed by MedGadget
Ensuring that patients adhere to a drug regimen is vitally important to help them manage their symptoms and long-term health prospects. In patients with chronic conditions, taking medication consistently is extremely important, as is monitoring their symptoms to adjust treatment.
Fibralign and MedTech Innovator Featured in General Surgery News
The prizes valued at $150,000 awarded to the company that won the 2014 MedTech Innovator competition were nothing to sneeze at; but just as important, if not more so, were the support and exposure the startup received as participants of MTI’s accelerator program.
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Intensix Raises $8.3M in Series A
Medical analytics platform developer Intensix said today it raised $8.3 million in a Series A financing round with funds slated to boost sales and marketing in North America and to accelerate development of its predictive analytics platform.
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SXSW Announces Bloomlife as 2017 Accelerator Finalist
More than five hundred companies submitted their web-based products to our ninth annual SXSW Accelerator Pitch Event. Competition was tough this year, but the results are in!
Harvard Study Shows MedAware Reduces Medication Error
Researchers at Harvard Medical School have demonstrated a new technology can help reduce a widespread problem that harms some 1.5 million people every year – medication error.
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Interview With Catalia Health CEO & Founder, Cory Kidd
Catalia Health is leading the surge in social robotics, with Mabu, their patient care management system. Catalia Health likes to be seen primarily as a health company that utilizes robots, rather than a robotics company.
SilverCloud Health Raises $8.1M in Series A
Digital Health company SilverCloud Health, the leading provider of evidence-based online mental health and behavioral healthcare solutions, announced that it has raised $8.1 million in Series A funding.
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Disease Diagnostic Group Wins Investment at Launch NY
Two health sciences startup companies in Buffalo scored $50,000 investments from Launch NY on Thursday.
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IntuiTap Team Named to Forbes 30 Under 30
Two Houston-based women have landed on the prestigious Forbes’ 30 under 30 list announced this week.
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Founder of Disease Diagnostic Group, John Lewandowski, Named in Forbes 30 Under 30
Their organizations have helped millions, and their impact wraps around the globe. Leading 30 different social ventures, we are honoring 40 young people (including a few cofounder teams) this year who are all working tirelessly to creatively solve some of the world’s toughest problems.
MobileODT Awarded FDA Clearance
We have some exciting news to share: as of December 19, 2016 the U.S. Food and Drug Administration approved our EVA (Enhanced Visual Assessment) System for marketing and sale in the United States!
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Green Sun Medical takes second place at the 2016 HITLAB World Cup
iBreastExam earned top honors and $5,000 USD by demonstrating the exceptional impact, innovation, feasibility, and business sustainability of its idea to judges Kara Dennis, MBA, MA, vice president and managing director of mobile health at Medidata; Jean-Luc Neptune, MD, partner, executive director and accelerator leader at Blueprint Health; Margaret Griffin, MPH, senior manager of innovation research at HITLAB; and Stan Kachnowski, PhD, MPA, CSEP, Chair at HITLAB.
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Mighty Oak Medical Receives Second FDA Clearance
Mighty Oak Medical (http://www.mightyoakmedical.com) announced today that its patient-specific, 3D printed FIREFLY® Pedicle Screw Navigation Guides have received a second FDA clearance extending compatibility to essentially all currently cleared pedicle screw systems.
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Adhesys comes out on top in MassChallenge 2016
Boston-based startup accelerator MassChallenge awarded $100,000 prizes to three of the “highest-impact” companies from its 2016 class at a ceremony on Wednesday night.
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uBiome raises $22M, announces new DNA-sequencing microbiome screening test
San Francisco-based uBiome, which makes a direct-to-consumer microbial genomic testing kit, has closed on a $22 million Series B funding round, led by 8VC with additional funding from Slow Ventures, Stanford’s StartX Fund and various angel investors.
Neural Analytics Receives FDA Clearance
Lucid Ultrasound System Holds Potential to Allow More Patients to Benefit from Brain Blood Flow Monitoring
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Green Sun Medical to compete in MedTech Innovator Final for $335K in prizes at AdvaMed 2016
Green Sun Medical, a Colorado-based startup company developing a transformative bracing technology for the treatment of adolescent scoliosis, was named by AdvaMed 2016: The MedTech Conference as one of four finalists in the annual MedTech Innovator global competition.
Neural Analytics recognized as 1 of 12 early-stage medical device startups to watch by CB Insights
Early-stage medical device startups are addressing important challenges in surgery, cardiology, and neurology, among other disciplines.
Digital Photonics and SilverCloud Health announced as finalists for the Vizient Annual Innovation Challenge
Vizient, Inc. announces the finalists for its fourth annual Innovation Challenge, an event designed to illuminate some of the best new ideas in healthcare today.
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Catalia mention in Boston Globe – Watch out Alexa, rivals are angling for your job
Designing a product is one thing, entrepreneur Cory Kidd says, and “manufacturing a good durable product, with a business around it, is something else.”
Neural Analytics lands $3M NIH grant
Neural Analytics landed a $3 million grant from the National Institutes of Health for the diagnostic and monitoring technology it’s developing for traumatic brain injury and stroke, the company reported. The NIH’s Small Business Innovation Research program funded the grant.
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Catalia mention – Meet Your Robot Pharmacist
Like many people, Peter Havas lives far from his parents. But while the San Francisco entrepreneur misses his mother and father in Australia, he doesn’t worry about their health.
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Following 23andMe playbook, uBiome hires ex-Genentech scientist to lead R&D drive
UBiome is stepping up its R&D activities. The personal microbiome sequencing pioneer has lured ex-Genentech scientist Audrey Goddard away from Genomic Health ($GHDX) to head up the unit.
SilverCloud discusses user experience in online mental health
When assessing the merits of online mental health solutions there are clear advantages in terms of the positive clinical outcomes they yield. However, we here at SilverCloud advocate that another significant aspect should be given consideration namely the user’s experience of their treatment.
Fibralign announces enrollment initiated for Stanford-led clinical trial for breast cancer-related Lymphedema
Fibralign Corporation announced that Stanford University has started enrollment in its investigator-led clinical study to evaluate the efficacy of a new surgical device for treating secondary lymphedema.
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Madorra mentioned in “The Latest Medical Device Startups You Need To Watch”
Technology and healthcare are evolving, and that means innovative medical device companies and products are advancing the industry and creating opportunities for sales reps.
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Linear Secures $1.25M Seed Round Investment
i2E Inc. recently led a $1.25 million seed round investment in Linear Health Sciences, a Norman-based innovative medical technology startup.
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Bloomlife gets $4M for wearable pregnancy tracker
San Francisco-based Bloomlife has raised $4 million for its smartphone-connected pregnancy-tracking wearable, bringing the startup’s total funding to $6 million.
MedAware – The Startup That Can Stop Your Doctor From Accidentally Killing You
A few years ago, a nine-year-old Israeli boy dropped dead from his bike. Why? Because of preventable medical error.
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Briteseed, IntuiTap and WestFace selected for the new TMCx program
The Texas Medical Center (TMC) Innovation Institute this week welcomes 11 startups selected from more than 100 applications to its accelerator program, TMCx, which for the first time is focusing exclusively on medical devices.
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Holly Rockweiler of Madorra is breaking barriers amidst tech’s ‘boys club’ turmoil
Holly Rockweiler wants to make this clear from the start: Her medical device startup is not making a vibrator.
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IntuiTap Medical receives ‘Startup of the Year’ nomination
IntuiTap Medical, a medical device company that grew from the inaugural class of TMC’s Biodesign program, is a nominee in Tech.Co‘s Startup of the Year competition.
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Adient Medical raises millions backed by Houston investors
Pearland-based Adient Medical Inc. has raised nearly $1.5 million from area investors and doctors as it looks to bring its medical device to human clinical trials early next year, according to a filing with the Securities and Exchange Commission.
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DDG accepted into STARTUP NY
43North today shared exciting updates on the winning companies from its 2014 and 2015 competitions. The $5 million startup competition attracts entrepreneurs from around the world to compete for prizes that turn startups with high growth potential into funded enterprises in the Western New York region.
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Admetsys is accepted into the Second TiE ScaleUp Cohort
On June 28, 2016, TiE-Boston introduced 14 companies who make up the second cohort for TiE ScaleUp.
MedAware is approved for investment from BIRD
The Israel-U.S. Binational Industrial Research and Development (BIRD) Foundation recently approved $7.5 million in funding for nine new projects between American and Israeli companies. The projects also will receive private sector funding, boosting their total value to approximately $21.5 million.
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uBiome Awards Two Microbiome Researchers $100,000
uBiome, the leading microbial genomics company, will double the number of academic researchers it will winning researchers, from the Yale School of Medicine and the University of Illinois at Chicago will therefore each receive up to $100,000 of uBiome microbiome testing kits and full laboratory analysis, fasttracking studies of the vaginal microbiome of women with unexplained infertility, and the gut microbiome of athletes.
Lightpoint Medical Announces Global License Agreement With the University of Arizona
Lightpoint Medical, a clinical‐stage medical device company developing advanced imaging technologies for intraoperative cancer detection, announced today that the company has signed an exclusive global license agreement for a molecular imaging technology called Beta Emission Tomography, developed by Professor Harrison Barrett, Regents Professor of Radiology and Optical Science, with his student Yijun Ding and colleague Dr.
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Meet LIM, the tech company creating the ultimate wearable: prosthetic sockets
But LIM isn’t working on a social app, or an Uber for X delivery service, or a bot. For the past five years LIM has been working on making the ultimate wearable: a prosthetic socket that is soft, adjustable, and modular.
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SafeHeal wins the most promising and innovative investor conference medtech startup at BIOVISION Conference
SafeHeal won the most promising and innovative investor conference medtech startup at the Conference in Lyon, France. 28 startup companies were selected to present at the BIOVISION Investor Conference.
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MiNDERA selected to present at BIOVISION Conference
MiNDERA has been selected as one of the emerging companies that will present at the BIOVISION Investor Conference to be held on April 13 and 14 2016 in Lyon, France.
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Rock West Medical Raised $1.25M
Competition could be rising for Medtronic’s ($MDT) Pillcam, an endoscopic imaging capsule as Californiabased Rock West Medical Devices raised $1.25 million in equity to advance its MoPill, an ingestible device that measures the motilityspontaneous and active movementof the gastrointestinal tract.
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Admetsys is accepted into the Dreamit Health 2016 accelerator class
Philadelphia-based accelerator Dreamit Health has announced the 15 health startups that will join its next accelerator class. As in previous years, the accelerator is sponsored by Penn Medicine and Independence Blue Cross, but this year, Dreamit Health also added medical device company Zimmer Biomet as a partner.
MedAware wins mHealth Israel Conference Competition
The mHealth Israel Conference, the largest Digital Health conference in Israel, announced today that the winners of its startup competition, MedAware and 6over6, will receive free booths and Tier 1 BizDev meetings at Medical World Americas.
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MindMaze Raises $100M At A $1B Valuation
As consumers and businesses begin to focus on what form the next generation of computing may take beyond our current era of the smartphone, startups developing at the cutting edge of these concepts are attracting some major attention from investors.
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Bloom Technologies wins Extreme Tech Challenge
Late Wednesday, Dy stood before Richard Branson for seven minutes and pitched his startup Bloom Technologies in the final round of the Extreme Tech Challenge contest.
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Bloom Technologies Takes First Prize in Extreme Tech Challenge
Necker Island, British Virgin Islands — A company dedicated to saving the lives of pre-term babies captured the attention of Sir Richard Branson and other judges at the Extreme Tech Challenge (XTC) finals today, as Bloom Technologies took first place out of over 2,000 entrants.
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Diagnostic Photonics raises $3.1 million for a probe to prevent repeat cancer surgeries
A Chicago-based company has raised $3.1 million to fund a clinical trial for its high-resolution imaging probes for cancer surgeons.
Neural Analytics Inc. Raises $10 MM Series A
Neural Analytics Inc., a medical device company focused on developing devices and services to measure, diagnose and track brain health, announced today that it has secured $10 MM in Series A financing.
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Spinal Singularity Wins at First PrimeUC Competition
Spinal Singularity, the startup founded by Derek Herrera, recent graduate of UCLA’s Anderson School of Management MBA program, won $150,000 in seed funding to develop and market a smart catheter that could vastly improve the lives of people with paralysis and others who suffer from neurogenic bladder dysfunction.
Lightpoint Medical receives 2.4M Euro grant
Lightpoint Medical, an innovative medical device company specializing in imaging technologies, announced today that it has received a 2.4M Euro grant from the European Commission as part of the Horizon 2020 European Union Framework Programme for Research and Innovation, enabling the company to carry out a large-scale clinical trial in breast cancer.
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Miracor Medical is highlighted at TCT 2015 in San Francisco
Miracor Medical Systems GmbH (Miracor) announced today that during this year’s TCT conference in San Francisco, PiCSO has been highlighted in several sessions as offering new hope for Cardioprotection during Percutaneous Coronary Intervention (PCI).
MobileODT’s CEO, Ariel Beery, is interviewed
Earlier this week we wrote about an innovative device from MobileODT that turns a cell phone into a colposcope for cervical cancer screening. Hot on the heels of winning the Medtech Innovator competition at AdvaMed, we had a chance to speak with Ariel Beery, the CEO of the company.
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Bloom Technologies is accepted into the Healthbox Salt Lake City Studio Cohort
Healthbox has announced its latest class of 14 healthcare technology companies that will participate in its combined Salt Lake City Studio and Intermountain Foundry Program launching this October.
Lightpoint Medical’s LightPathTM Imaging System is CE marked
“We are delighted to have achieved the major landmark of a CE mark for Lightpoint’s first product offering: the LightPath™ Imaging System,” said Dr David Tuch, CEO of Lightpoint Medical. “Bringing LightPath™ to market is an important milestone in our efforts to transform cancer surgery.”
Lightpoint Medical’s LightPath Imaging System now CE marked
Lightpoint Medical, an innovative medical device company specializing in imaging technologies, announced today that the LightPath™ Imaging System is now CE marked, enabling the launch of the device in Europe.
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MiNDERA Corp closes Seed round and adds Andrew Offer to its Board
MiNDERA Corp. (“MiNDERA), a leader in non‐invasive molecular diagnostics for dermatology and skin‐related cancers, announced today the close of its $1 million Seed financing round.
MedAware’s Interview with Medgadget
The 2015 MedTech Innovator competition has recently announced their coveted 4 finalists. The finalists will compete at the AdvaMed 2015 conference for $300,000 in prizes.
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AventaMed raises €1.3m
Cork company AventaMed, which hopes to greatly simplify the procedure millions of children undergo to have grommets inserted, has raised €1.3 million to run clinical trials on its device.
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Mindera nominated for 2015 Diagnostics Startup of the Year
The Diagnostics Startup of the Year Award recognizes the achievements of either a genuine startup or a business that has moved into a new Þeld. Elbowing into a new space in an already crowded industry takes guts, perseverance, brilliant marketing and a tremendous ability to learn fast.
Lightpoint Medical and PartnerTech sign global manufacturing agreement
Lightpoint Medical, a clinical stage medical device company developing advanced imaging technologies for intra-operative cancer detection, announced today that the company has signed a global contract with PartnerTech, to build, test and distribute their molecular imaging system, LightPath™ at their facility in Cambridge, UK.
Lightpoint Medical Secures $2.6M Grant From National Cancer Institute
Lightpoint Medical, an innovative medical device company specializing in imaging technologies announced today that it has received an R01 grant of $2.6M million from the US National Cancer Institute.
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Vynca Wins Silicon Valley Boomer Venture Summit Business Plan Competition
Health management tech company Vynca won grand prize at the Silicon Valley Boomer Venture Summit’s Business Plan Competition, June 30 at Santa Clara University.
Lightpoint Medical wins UKBAA Award
Lightpoint Medical is honored to win the 2015 Award for Best Crowdfunding-Angel Investment of the Year from theUK Business Angels Association. The company was chosen for the award by a distinguished judging panel of industry and government leaders.
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Admetsys Awarded Top Company at the 2015 Digital European Venture Summit
Jeff Valk, CEO of Admetsys ApS, is honored to announce his company’s distinction as a Top Company Award Winner at the 2015 Digital Health Venture Forum in Aarhus, Denmark.
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Admetsys wins Worcester’s Five Minute Pitch Contest
Boston-based Admetsys was the winner of The Venture Forum’s ninth annual Five-Minute-Pitch contest, held in Worcester Tuesday.
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Briteseed vs. Surgical Perspective
The SafeSnips patented, intraoperative platform technology can be integrated into existing surgical cutting tools to facilitate the real-time detection of blood vessels before surgical cuts are made.
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Admetsys Wins Top Prize at SXSW Hatch Pitch competition
victorious, including a few big winners. Here they are, as well as the six other
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Vixiar Medical Receives BioMaryland Development Award
Vixiar Medical, Inc. announced today that it was awarded a $200,000 grant by the State of Maryland to accelerate the commercialization of its non-invasive congestive heart failure (CHF) device.
Fibralign beats 267 other startups at the 2014 MedTech Innovator competition
Fibralign, a startup medical device company, just took home the grand prize in the 2014 MedTech Innovator competition, winning over 267 other startups.
Fibralign set to bring new device option for secondary lymphedema
A young company developing a product to address secondary lymphedema, a chronic disease with no cure, stole the show at a venture competition held during a recent medical device conference.
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