Author: Ken Dropiewski

Microbot Medical Announces Outcome of Annual Meeting of Shareholders

Maintains Regulatory Pre-Submission Timeline of the Self-Cleaning Shunt (SCS TM) HINGHAM, Mass., Sept. 13, 2019 (GLOBE NEWSWIRE) —  Having successfully executed a number of significant milestones over the past twelve months, Microbot Medical Inc. (NASDAQ: MBOT) held its 2019 annual shareholders’ meeting on September 10, 2019, during which the shareholders re-elected three […]

Rex Medical Receives 510k Clearance for Revolution™ Peripheral Atherectomy System

CONSHOHOCKEN, Pa.–(BUSINESS WIRE)–Rex Medical, L.P., a medical device design and development company, today announced that it has received 510k Clearance from the U.S. Food and Drug Administration (FDA) for the Revolution™ Peripheral Atherectomy System. Regulatory clearance was based on data provided by the REVEAL IDE clinical trial. The results of […]

CARMAT announces FDA conditional approval to initiate US clinical feasibility study of its total artificial heart

CARMAT provided sufficient data to support the initiation of a human clinical study Study to include 5 patients in selected renowned US institutions CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage […]

Corvia Medical and physIQ Partner in Global Phase 3 Heart Failure Clinical Trial to Leverage Novel Digital Endpoints

BOSTON–(BUSINESS WIRE)–Corvia Medical has sponsored and is actively enrolling patients in an innovative heart failure (HF) device trial that, in addition to measuring traditional heart failure endpoints, includes collecting and analyzing biosensor data with physIQ’s continuous remote monitoring platform. The clinical trial is designed to evaluate the clinical efficacy of […]

HeartFlow Announces FDA Clearance for HeartFlow Planner

REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc. today announced that it has obtained clearance from the U.S. Food and Drug Administration (FDA) for the HeartFlow Planner, a non-invasive, real-time virtual modeling tool for coronary artery disease (CAD) intervention. The HeartFlow Planner will enable interventional cardiologists to virtually model clinical scenarios vessel-by-vessel, explore treatment strategies […]

Correvio Highlights FDA Acceptance of United Therapeutics’ Trevyent New Drug Application

VANCOUVER, Sept. 12, 2019 /PRNewswire/ – Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today highlighted that the U.S. Food and Drug Administration (FDA) has accepted for review United Therapeutics Corporation’s (NASDAQ: UTHR) New Drug Application (NDA) for Trevyent® (treprostinil) for the treatment of pulmonary arterial hypertension […]

CryoLife Enters Into Distribution Agreement with Endospan

Positions the Company for Accelerating Revenue and Non-GAAP Earnings Growth Over the Next Five Years Conference Call and Webcast Tomorrow, September 12, 2019 at 8:00 a.m. ET ATLANTA, Sept. 11, 2019 /PRNewswire/ — CryoLife, Inc. (“CryoLife”;NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has entered […]

GE Healthcare Accelerates AI Model Development and Deployment with Launch of Edison Integration to American College of Radiology AI-LAB™

Edison AI platform will integrate with ACR AI-LABTM, providing ACR members and other radiology professionals with connectivity to valuable Edison AI services Among the 100+ GE Healthcare AI developer services on Edison is a tool that tracks the source and usage of data in AI development, simplifying radiologists’ ability to […]

REDUCE FMR Study Shows Cardiac Dimensions’ Carillon® System Significantly Improves Mitral Regurgitation And Slows Worsening Of Heart Failure

KIRKLAND, Wash., Sept. 12, 2019 /PRNewswire/ — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure (HF), today announced the publication of the REDUCE FMR clinical study of its Carillon Mitral Contour System®. The Carillon® System is a right heart […]

V-Wave Receives Second FDA Breakthrough Device Designation: Interatrial Shunt for Pulmonary Arterial Hypertension

CAESAREA, Israel, Sept. 12, 2019 /PRNewswire/ — V-Wave Ltd., a privately held medical device company developing novel implantable interatrial shunt devices, today announced that the U.S. Food and Drug Administration (FDA) has granted the company a second Breakthrough Device Designation – the first was for its interatrial shunt for Heart Failure (HF), and […]