The Latest Cardiac and Vascular News
NETANYA, Israel, October 11, 2018 /PRNewswire/ — Transseptal Solutions Ltd., developer of an innovative Transseptal Access System with a novel approach of transseptal puncture and left atrial navigation to introduce various cardiovascular catheters into the left heart chambers, announced today that the company has […]
VANCOUVER, Oct. 10, 2018 /PRNewswire/ – Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ: NVCN) (TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, today […]
NEW YORK, Oct. 2, 2018 /PRNewswire/ — Xtreem Pulse LLC is pleased to announce that PureFlow received 510Kclearance from the FDA for chronic stable angina that is refractory to optimal anti-anginal medical therapy and without option for revascularization. Intended for use in healthy […]
COPENHAGEN, Denmark, October 2, 2018 /PRNewswire/ — CathVision ApS, an early stage medical device company developing an advanced cardiac electrophysiology recording system, CUBE, announced today that the company received ISO 13485:2016 certification for Medical Device and Quality Management Systems from Lloyd’s Register. This ISO […]
IRVINE, Calif., SEPTEMBER 26 – Johnson & Johnson Medical Devices Companies* announced today that Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of heart arrhythmias, has received approval from the U.S. Food and Drug Administration (FDA) for […]
TEL AVIV, Israel, Sept. 24, 2018 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced that its novel […]
MARLBOROUGH, Mass., Sept. 24, 2018 /PRNewswire/ — Today, Boston Scientific (NYSE :BSX ) announced that the U.S. Food and Drug Administration (FDA) has approved its Premarket Approval (PMA) application to market the Eluvia™Drug-Eluting Vascular Stent System, specifically developed for the treatment of peripheral artery disease […]
RALEIGH, N.C., Sept. 18, 2018 /PRNewswire/ — Contego Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the first filter-based Integrated Embolic Protection (IEP) device, the Paladin® Carotid PTA Balloon System. Contego Medical is developing and commercializing […]
SILVER SPRING, Md., Sept. 14, 2018 /PRNewswire/ — The U.S. Food and Drug Administration today approved a device intended to treat acute coronary artery perforations, or tears in the blood vessels of the heart. The PK Papyrus Covered Coronary Stent System is the […]
BRIDGEWATER, N.J. and TARRYTOWN, N.Y., Sept. 12, 2018 FDA also recently approved Praluent label update for some patients currently requiring LDL apheresis therapy /PRNewswire/ — Sanofi and Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License […]
