Author: Ken Dropiewski

Medtronic HeartWare(TM) HVAD(TM) System Approved for Destination Therapy

DUBLIN – September 27, 2017 – Medtronic plc (NYSE: MDT) has received U.S. Food and Drug Administration (FDA) approval for its HeartWare(TM) HVAD(TM) System as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants. The HVAD System, a left ventricular assist device or LVAD, […]

Newly Published Peer Reviewed Study Reveals Benefits Of ClearFlow’s PleuraFlow ACT System

ANAHEIM, Calif.–(BUSINESS WIRE)–ClearFlow Inc., a medical device company based in Anaheim, California, has announced the publication of significantly positive results in a study evaluating the company’s PleuraFlow® Active Clearance Technology® System. Data from a peer-reviewed clinical study indicating a marked reduction in Postoperative Atrial Fibrillation (POAF) among patients with active clearance of chest […]

LivaNova (LIVN) And MicroPort Scientific (MCRPF) Announce The Approval Of Rega Pacemakers By The China Food And Drug Administration

LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN) (“LivaNova”) and MicroPort Scientific Corporation (HK:00853) (“MicroPort”), today announced that the companies’ Shanghai-based joint venture MicroPort Sorin Cardiac Rhythm Management Co. Ltd. (“MSC” or the “joint venture”) obtained approval for its family of RegaTM pacemakers from the China Food and Drug Administration. Not only are Rega pacemakers […]

Abiomed (ABMD) Gets in on Magenta Medical’s $15 Million Funding Round

TEL-AVIV, Israel, September 28, 2017 /PRNewswire/ — Magenta Medical, a medical device company in the field of transcatheter heart failure therapy, announced today the successful closing of its $15M series B financing round. The syndicate of investors is comprised of Abiomed Inc., a leader in transcatheter heart pumps, Pitango Venture Capital, among Israel’s leading venture capital […]

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA actions to bring relief to citizens of Puerto Rico; to help the island recover its considerable and economically vital medical product manufacturing base; and to prevent critical shortages of life-saving drugs made in Puerto Rico

As an agency dedicated to promoting public health, and as fellow Americans, the staff at the U.S. Food and Drug Administration is doing all it can to support the immediate needs of Puerto Ricans following the destruction of Hurricane Maria. First and foremost, these efforts are focused around our mission […]

Analytics 4 Life Raises $25 Million in Series B Financing to Advance its Artificial Intelligence-Backed Cardiac Imaging Technology

RESEARCH TRIANGLE PARK, NC and TORONTO, CANADA, September 27, 2017 — Analytics 4 Life, a digital health company applying the power of artificial intelligence to develop solutions that improve existing care pathways, today announced it has completed a $25 million Series B financing. This unique financing event was supported by an […]

Avinger Receives CE Marking Approval for In-Stent Restenosis Treatment Indication With Pantheris Image-Guided Atherectomy

REDWOOD CITY, Calif., Sept. 26, 2017 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for Peripheral Artery Disease (PAD), today announced Conformité Européenne (CE) Marking approval for treating in-stent restenosis with the Pantheris® Lumivascular atherectomy system. In-stent restenosis occurs when a previously blocked artery treated with […]

Corindus Announces Opening of First International Robotic Training Center

WALTHAM, Mass.–(BUSINESS WIRE)–Corindus Vascular Robotics, Inc. [NYSE American: CVRS], a leading developer of precision vascular robotics, announced today the opening of the first international CorPath GRX Robotic Center in Tokyo, Japan. Earlier this year, Corindus partnered with Japan Medicalnext Co., Ltd., a wholly-owned entity of MC Healthcare, Inc. (subsidiary of […]

CardioFocus® Announces European CE Mark Approval Of The Next-Generation HeartLight® Excalibur Balloon™ Designed For The Treatment Of Atrial Fibrillation

MARLBOROUGH, Mass., Sept. 27, 2017 /PRNewswire/ — CardioFocus, Inc. today announced the European CE Mark approval of the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of atrial fibrillation (AF). The Excalibur Balloon leverages the proven universal balloon design of the company’s FDA-approved HeartLight® Endoscopic Ablation System and introduces an advanced feature set that optimizes the speed […]

TVA Medical Receives CE Mark For Next-Generation everlinQ 4 endoAVF System

AUSTIN, Texas, Sept. 27, 2017 /PRNewswire/ — TVA Medical, Inc., a medical device company developing innovative therapies for end-stage renal disease (ESRD), today announced that its everlinQTM 4 endoAVF System has received CE Mark in the European Union. The technology uses a 4 French catheter system with enhanced visual indicators to create hemodialysis access […]