The Latest Cardiac and Vascular News
NEW YORK and MELBOURNE, Australia, Dec. 21, 2017 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO) (ASX:MSB) today announced that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for its novel mesenchymal precursor cell (MPC) therapy […]
SALT LAKE CITY–(BUSINESS WIRE)– XableCath, a clinical stage medical device company, announced its XableCath blunt tip support catheter has received clearance from the FDA. The blunt tip catheter facilitates true lumen passage of lesions, both above and below the knee, in the […]
THOUSAND OAKS, Calif., Dec. 1, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that following priority review of its supplemental Biologics License Application, the U.S. Food and Drug Administration (FDA) approved Repatha® (evolocumab) as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary […]
Gottlieb updates on Puerto Rico med device manufacturing recovery OCTOBER 20, 2017 BY SARAH FAULKNER In the weeks following Hurricanes Irma and Maria, the people and leadership in Puerto Rico have been working to rebuild the island’s infrastructure. The FDA, which has […]
EXTON, Pennsylvania, Oct. 9, 2017 /PRNewswire/ –Essential Medical, Inc. today announced initiation of enrollment in a post market clinical registry in the regions where MANTA is commercially available. Principle Investigator Nicolas Van Mieghem, MD, PhD, Medical Director of the Department of Interventional Cardiology […]
Endovascular Graft Systems: Letter to Health Care Providers – Type III Endoleaks Associated with Use [Posted 09/28/2017] AUDIENCE: Risk Manager, Surgery, Cardiology, Radiology ISSUE: The FDA is evaluating recent information regarding Type IIIa and IIIb endoleaks with the use of […]
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. […]
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 […]
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 […]
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) and CE Mark clearance for its .014” […]
