Author: Ken Dropiewski

CARMAT Confirms the Definitive Approval of its “Forfait Innovation” Dossier by the French National Authority for Health (HAS)

With this favorable opinion, CARMAT will request financing of its device within the framework of a clinical study in France PARIS–(BUSINESS WIRE)–Regulatory News: 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 […]

Windtree Presents New Istaroxime Phase 2b Study Analysis at the American College of Cardiology (ACC) Congress

Efficacy of 24 Hour Istaroxime Infusion is Similar Between Caucasian and Asian Patients Hospitalized for Acute Heart Failure WARRINGTON, Pa., April 6, 2020 /PRNewswire/ — Windtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology and medical device company focused on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases, […]

SHOCKWAVE COMPLETES ENROLLMENT IN PIVOTAL STUDY FOR CORONARY INTRAVASCULAR LITHOTRIPSY

Last Patient Enrolled in DISRUPT CAD III, the U.S. FDA IDE Study for IVL in Severely Calcified Coronary Arteries SANTA CLARA, Calif., April 06, 2020 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, […]

Endologix Announces Preliminary Financial Results for First Quarter 2020

IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (the “Company”) (NASDAQ: ELGX), a developer and marketer of innovative treatments for aortic disorders, today announced that its preliminary unaudited revenue for the first quarter ended March 31, 2020 is expected to be approximately $28.5 million. Total cash, cash equivalents, and restricted cash as of March […]

Mardil Medical Completes Treatment Of Third Patient In VenTouch™ Device Trial

MINNEAPOLIS, April 3, 2020 /PRNewswire/ — Mardil Medical, Inc., today announced the successful completion of treatment for the third patient in the clinical trial of its improved VenTouch™ device.  VenTouch is a combination therapy which simultaneously treats the distorted valve, the dilated ventricle and the displaced papillary muscles in patients suffering from Type IIIb Functional Mitral Valve […]

Windtree Therapeutics Reports Fourth Quarter 2019 Financial Results and Provides Key Business Updates

WARRINGTON, Pa., April 2, 2020 /PRNewswire/ — Windtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology and medical device company focused on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases, today reported financial results for the fourth quarter ended December 31, 2019 and provided key business updates. Key Business and Financial […]

CHF Solutions Doubles Production Staff of Aquadex SmartFlow™ Consoles Due to Hospital Demand

EDEN PRAIRIE, Minn., April 02, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS), a medical device company dedicated to changing the lives of patients suffering from fluid overload, announced that it has doubled the production staff that builds its next generation Aquadex SmartFlow consoles in response to increased demand from […]

Artio Medical Closes $8.8 Million of Additional Financing

FAIRWAY, Kan., March 31, 2020 /PRNewswire/ — Artio Medical, Inc. (Artio), a medical device company developing innovative products for the peripheral vascular and neurovascular markets, announced today it has closed an additional $8.8 million in Series A financing, bringing the total capital raised to date to more than $20 million. “Artio is developing a strong […]

Former J&J/Biosense Webster Exec, Roy Tanaka, Joins S4 Medical’s Board of Directors

CLEVELAND, March 31, 2020 /PRNewswire/ — S4 Medical, an innovative medical device company focused on protecting the esophagus from damage during catheter ablation procedures, announced that Roy Tanaka has joined its board of directors, rounding out an impressive team. S4 Medical has developed a novel catheter called the “esolution” that utilizes a proprietary approach to […]

MediLynx Cardiac Monitoring, LLC introduces dedicated remote monitoring services based on its PocketECG® platform to support hospitals in managing COVID-19 patients in accordance with the latest FDA enforcement policy

PocketECG, MediLynx’s FDA approved remote monitoring systems: PocketECG Unified Arrhythmia Diagnostic System will be used for continuous streaming and analysis of full-disclosure ECG data, oxygen saturation, resting heart rate, patient symptoms and arrhythmia. The device is cleared by the FDA for the use of its data to analyze, measure and […]