Author: Ken Dropiewski

Amarin Provides Update on VASCEPA® (Icosapent Ethyl) Regulatory Review Processes in Mainland China and Hong Kong

DUBLIN, Ireland and BRIDGEWATER, N.J., Feb. 09, 2021 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that its corporate partner in China, Edding, has progressed VASCEPA® (icosapent ethyl) into commencement of the regulatory review processes in Mainland China and Hong Kong. In Mainland China, the Chinese National Medical Products Administration […]

Neovasc Regains Compliance with Nasdaq Minimum Bid Price Rule

VANCOUVER and MINNEAPOLIS, Feb. 09, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) announced today that it has received written notification from the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) pursuant […]

InspireMD Announces Closing of an Upsized $20.7 Million Underwritten Public Offering and Full Exercise of Over-Allotment Option

TEL AVIV, Israel, Feb. 08, 2021 (GLOBE NEWSWIRE) — InspireMD, Inc. (“InspireMD”) (NYSE:NSPR), a medical device company focused on the development and commercialization of proprietary MicroNet stent platform technology for the treatment of vascular and coronary diseases in Europe, Latin America, the Middle East and Asia, today announced the closing […]

Geisinger researchers find AI can predict death risk

Algorithm using echocardiogram videos of the heart outperforms other predictors of mortality DANVILLE, Pa., Feb. 9, 2021 /PRNewswire/ — Researchers at Geisinger have found that a computer algorithm developed using echocardiogram videos of the heart can predict mortality within a year. The algorithm—an example of what is known as machine learning, or artificial […]

Covanos Names Mark D. Carlson, MD as Senior Vice President and Chief Medical Officer

ATLANTA, Feb. 9, 2021 /PRNewswire/ — Covanos, Inc., a privately-held medical technology company that is developing C-HEART, a PC-based software product that uses proprietary advances in computational fluid dynamics to rapidly and non-invasively diagnose the severity of coronary artery blockages, today announced that it has named Mark D. Carlson, MD, MA to the position of […]

Philips completes the acquisition of BioTelemetry, Inc.

Combination of Philips and BioTelemetry results in a global leader in patient care management solutions for the hospital and the home Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that it has completed the acquisition of BioTelemetry, Inc. (NASDAQ: BEAT), a leading U.S.-based provider of […]

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

MONTREAL, Feb. 8, 2021 /PRNewswire/ – 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. The FDA Breakthrough Device Program is intended to help patients receive more timely access […]

EndoWays LTD, Developer of the First Disposable Robot for the Cathlab, Acquired by Ascendum

OR YEHUDA, Israel, Feb. 8, 2021 /PRNewswire/ — EndoWays, developer of a disposable robotic system for the cathlab, today announced the completion of an acquisition of a majority of its shares by Ascendum at an undisclosed cash amount. EndoWays, which was founded in 2018 by Noam Shamay, Tovy Sivan and Tamir Ben David, is a portfolio company of MEDX […]

BioVentrix Receives 2021 NUB Status 1 Reimbursement Renewal in Germany for the Revivent TC TransCatheter Ventricular Enhancement System

SAN RAMON, Calif.–(BUSINESS WIRE)–BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure (CHF) via Transcatheter based Ventricular Restoration (TCVR), today announced that the German Institute for Hospital Remuneration (InEK) has renewed the NUB Status 1 reimbursement designation in Germany for the Revivent TC™ TransCatheter Ventricular Enhancement […]

TCAI physicians participate in clinical trial for potential life-saving device for patients with heart rhythm disorders

AUSTIN, Texas, Feb. 5, 2021 /PRNewswire/ — Physicians with the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center are among the first in the world to participate in a clinical trial to evaluate a new esophageal protection device designed to make ablation procedures safer for patients with atrial fibrillation (A Fib), the most […]