Author: Ken Dropiewski

Occlutech Announces First Patient Enrollment in Important US Pivotal Study for the Atrial Flow Regulator (FROST-HF)

SCHAFFHAUSEN, CH / ACCESSWIRE / March 13, 2023 / Occlutech Holding AG (“Occlutech”), one of the world’s leading providers of minimally invasive structural heart disease devices, continues its progress in the US market. Today, the company has announced that the first patient has been enrolled in the FROST-HF study. The FROST-HF […]

Terumo Prospective Registry Reinforces Safety, Efficacy and Efficiency of Radial Access in Visceral Interventions (R.A.V.I.) in Embolization Procedures

– Findings show intra-vascular access via the radial artery can successfully be used as the primary strategy for the modern embolization practice – SOMERSET, N.J., March 13, 2023 /PRNewswire/ — Terumo Medical Corporation (TMC) is pleased to announce the final results of its study demonstrating the safety and efficacy of Radial Access in […]

ConcertAI’s TeraRecon and Avicenna.AI Partner on AI for Incidental Pulmonary Embolism

Medical imaging AI companies collaborate to offer CINA-iPE on TeraRecon’s Eureka Clinical AI platform. CAMBRIDGE, Mass., March 13, 2023 /PRNewswire/ — ConcertAI’s TeraRecon, the advanced visualization and AI Clinical SaaS category leader, today announced a partnership to offer medical imaging AI specialist Avicenna.AI‘s CINA-iPE solution detecting the presence of incidental pulmonary embolisms as part of […]

Microbot Medical Increases Presence in the EU with the Addition of Greece-based Key Opinion Leader Stavros Spiliopoulos, MD, PhD, EBIR-ES, FCIRSE, to its Scientific Advisory Board

Internationally Recognized and Awarded Interventional Radiologist Enhances Depth of Expertise as the LIBERTY® Robotic System Races Towards Regularity and Commercialization Objectives HINGHAM, Mass., March 13, 2023 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), which continues to experience a rising interest in the LIBERTY ® Robotic System, the first single-use endovascular robotic […]

Windtree Regains Compliance with Nasdaq

WARRINGTON, Pa., March 13, 2023 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today announced it has received a Bid Price Compliance Letter from The Nasdaq Stock Market LLC (“Nasdaq”) informing Windtree that it has […]

Vivasure Medical Announces FDA IDE Approval to Initiate U.S. Pivotal Study

Pivotal study expected to be completed by year-end 2023 and set the stage for commercialization of PerQseal® system for large hole vessel closure Company announces €30 million strategic investment from Haemonetics as part of its previously disclosed Series D financing GALWAY, Ireland–(BUSINESS WIRE)–Vivasure Medical® Limited (“Vivasure” or the “Company”), a company pioneering novel […]

Valbiotis Announces the Last Visit of the Last Patient in the Phase II/III REVERSE-IT Study on TOTUM•63, in Partnership with Nestlé Health Science

The last patient included in the study has completed the final protocol follow-up visit. The first results of the study will be released before the end of the first half of 2023, after the database is frozen and the statistical analysis work is completed. This international, multicenter Phase II/III study […]

LivaNova Receives U.S. FDA 510(k) Clearance for Essenz Heart-Lung Machine for Cardiopulmonary Bypass Procedures

LONDON–(BUSINESS WIRE)–LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology and innovation company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Essenz™ Heart-Lung Machine (HLM). With FDA clearance, LivaNova initiates the commercial launch of Essenz in the U.S. The Company also recently received approval for […]