Cohort Company News - MedTech Innovator

Promaxo Receives 510(k) Clearance from the FDA for its Innovational MRI Platform

DateMar 08 2021

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

DateMar 03 2021

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.

Soundbite Medical Wins Health Canada Approval for PAD Treatment

DateMar 02 2021

The SCS-P (14P) is intended to treat patients suffering from PAD with heavily calcified above-the-knee (ATK) and below-the-knee (BTK) chronic total occlusions (CTO).

Vetex Medical Receives FDA Clearance for Revene Thrombectomy Catheter

DateMar 01 2021

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.

Protembis announces completion of 20 cases in European CE mark study with the ProtEmbo® Cerebral Protection System

DateFeb 25 2021

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. The ProtEmbo® System is an intra- aortic filter device that deflects embolic material away from the brain during transcatheter aortic valve replacement (TAVR).

Redox Raised $45M To Connect Healthcare Data In The Cloud

DateFeb 24 2021

Redox, which is geared towards software developers and hospital systems, aims to do for healthcare what Plaid did for the financial services industry.

Forest Devices Announces Positive Study Results for Their Stroke Detection Technology

DateFeb 23 2021

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.

MedAware Systems Launches AI Post Market Surveillance for Neuromodulation Devices

DateFeb 11 2021

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

DateFeb 11 2021

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.

Fibralign Announces Start of European Lymphedema Prevention Clinical Study

DateFeb 09 2021

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.

Puzzle Medical Devices Inc. Receives U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for Its Revolutionary Minimally Invasive Transcatheter Heart Pump

DateFeb 08 2021

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.

Flow expands portfolio of brain stimulation technologies with Halo acquisition

DateFeb 05 2021

Swedish firm Flow Neuroscience has added to its portfolio of brain stimulation technologies for improving mental wellbeing by acquiring US start-up Halo Neuroscience.

Interventional Robotics Startup Moray Medical Secures $3.3 Million Seed Financing Led by 415 CAPITAL

DateJan 27 2021

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.

PEDRA™ Technology Receives FDA Breakthrough Device Designation for its PEDRA™ Xauron™ Real-Time Tissue Perfusion System

DateJan 25 2021

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

DateJan 25 2021

The technology offers a no-implant interatrial shunt therapy for patients suffering from heart failure with preserved (HFpEF) and mid-range ejection fraction (HFmrEF) who remain symptomatic despite optimal guideline directed medical therapy.

Israeli AI FemTech solution secures prestigious US cancer grant of $2.3M to advance women’s health (featuring MobileODT)

DateJan 25 2021

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. The Small Business Innovation Research Authority grant is given by the NCI to companies that are technologically and clinically reducing the suffering from cancer.

Harvard spin-off CELLVIE closes $5M seed round in pursuit of a new treatment modality: therapeutic mitochondria transfer

DateJan 25 2021

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

DateJan 20 2021

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.

Hillrom Announces Planned Acquisition Of Bardy Diagnostics, Inc.

DateJan 19 2021

Hillrom 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.

BIRD – Israel-U.S. Binational Industrial R&D Foundation to Invest $7.45M in Eight New Projects, featuring Donisi Health

DateJan 19 2021

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. and Israeli companies.