Cohort Company News - MedTech Innovator

Empirical Spine’s LimiFlex Device Granted Breakthrough Designation Status

DateApr 06 2021

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device status to Empirical Spine Inc.'s LimiFlex Paraspinous Tension Band.

Sentien Biotechnologies Completes Enrollment of First Cohort in Phase 1/2 Trial of Ex Vivo MSC Therapy for the Treatment of Severe COVID-19

DateMar 30 2021

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. SBI-101, Sentien’s innovative cell-based therapy, is being evaluated in COVID-19 patients suffering from both acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) requiring renal replacement therapy (RRT).

Augmedics, Augmented Reality Surgical Image Guidance Pioneer, Raises $36 Million in Series C Fundraising

DateMar 30 2021

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.

PolyVascular Awarded $2 Million Small Business Innovation Research Grant to Bring the First Polymer-Based Heart Valve for Children to Clinical Trials

DateMar 30 2021

PolyVascular Hires Will Clifton, MD, as COO to Manage Path to Human Trials in US; Ultimate Goal to Help 1 Million Pediatric Patients With Congenital Heart Disease Around the World With More Dependable and Affordable Solution.

Medical artificial intelligence company Vuno announces initial public offering

DateMar 25 2021

South Korean medical AI company made its debut on KOSDAQ, a trading board of Korea Exchange, for an IPO of 37.8 billion won ($33.6 million) by issuing 1.8 million shares.

This new artificial heart responds to the patient, featuring CorWave

DateMar 25 2021

Another French company -- CorWave -- is developing a device for people with less severe heart failure. It helps pump blood from one of the heart's four chambers, rather than replacing the whole heart.

Lightpoint Medical Announces $8 Million in Funding to Support Commercial Launch of its Robotic Cancer Detection Probe

DateMar 25 2021

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.

Endotronix Celebrates 100th Implant Of The Cordella Pulmonary Artery Pressure Sensor For Proactive, Remote Management Of Heart Failure

DateMar 23 2021

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.

LimFlow Receives Japan PMDA Approval for Clinical Study of Minimally-Invasive Technology Designed to Prevent Amputations in Chronic Limb-Threatening Ischemia Patients

DateMar 23 2021

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.

SeaSpine® Announces Agreement to Acquire 7D Surgical

DateMar 22 2021

In February 2020, SeaSpine announced that it had entered into a strategic alliance agreement to distribute 7D Surgical’s flagship navigational system founded on its machine-vision, image-guided surgery platform.

Up to 10% of intraoperative time is spent on preventable delays, ExplORer Surgical drives improved efficiencies

DateMar 17 2021

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.

Vetex Medical Announces Positive One-Year Outcomes for Revene Thrombectomy Catheter

DateMar 17 2021

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.

Bigfoot Biomedical® Secures up to $57 Million in Combined Debt and Equity Financing from Madryn Asset Management

DateMar 17 2021

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

DateMar 16 2021

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.

A bracelet that triggers the production of endorphins, without addiction, featuring Remedee

DateMar 15 2021

Remedee Labs is now scheduled to conduct a clinical trial, scheduled to begin in the second quarter of 2021, for a period of 12 months. This project is being carried out jointly with the CHU Grenoble Alpes, the Clinatec research center, the National Institute for Health and Medical Research (Inserm) and the company STMicroelectronics.

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).