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 received FDA 510(k) clearance for the TSP Crosser[TM] Transseptal Access System. […]
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 announced that the U.S. Food and Drug Administration (the “FDA”) […]
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 patients to provide improvement in vasodilation, increased VO2, and increased […]
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 certification indicates that the company’s quality management system meets the […]
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 its VISITAG SURPOINT External Processing Unit and enrollment has begun […]
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 CGuard™ Embolic Prevention System (EPS) has been granted regulatory approval […]
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 (PAD). The Eluvia stent utilizes a drug-polymer combination to offer […]
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 a suite of next-generation devices that address unmet needs in […]
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 first device approved by the FDA for this indication in […]
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 Application (sBLA) for Praluent® (alirocumab) Injection, a PCSK9 inhibitor. The […]
