The Latest Cardiac and Vascular News
KFAR-SABA, Israel & ALISO VIEJO, Calif.–(BUSINESS WIRE)–CathWorks announced today that its FFRangio™ System received United States Food & Drug Administration (FDA) 510(k) clearance. The FFRangio system demonstrated accuracy versus the invasive FFR wire in a blinded comparative study, FAST-FFR. The results of the FAST-FFR pivotal study were used to establish substantial […]
SANTA CLARA, Calif.–(BUSINESS WIRE)–Cardiva Medical, Inc., an innovator in the field of vascular closure, today announced that the company has received PMA approval from the U.S. Food and Drug Administration (FDA) for the VASCADE® MVP Venous Vascular Closure System. VASCADE MVP is the first and only vascular closure system designed […]
IRVINE, Calif., Dec. 17, 2018 (GLOBE NEWSWIRE) — Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a company specializing in medical devices that restore cardiac and vascular health, announced today that it has received regulatory approval from INVIMA, the Colombian equivalent of the U.S. Food and Drug Administration, for its first-in-human […]
BELLEVUE, Wash.–(BUSINESS WIRE)–Aortica Corporation today announced that FDA has approved a supplement to an ongoing Physician Sponsored IDE study at the University of Washington (UW) sponsored by Principal Investigator & Chief of Vascular Surgery Dr. Benjamin Starnes. The positive decision allows the use of Medtronic’s Valiant NAVION™ stent graft system […]
IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced U.S. Food and Drug Administration (FDA) approval of expansion of its Investigational Device Exemption (IDE) feasibility studies for the JenaValve Pericardial TAVR System with the Everdur™ transcatheter heart valve (THV) and […]
ANN ARBOR, Mich., Nov. 14, 2018 /PRNewswire/ — Terumo Cardiovascular Group, a global leader in cardiovascular surgery technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CDI® Blood Parameter Monitoring System 550, adding real-time monitoring of oxygen delivery as one of 12 critical blood parameters. Oxygen […]
DUBLIN – October 23, 2018 – Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval for the Valiant Navion(TM) thoracic stent graft system for the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), blunt thoracic aortic […]
DEXTER, Mich., Oct. 18, 2018 /PRNewswire/ — MC3 (mc3corp.com) today announced the launch of the Crescent™Jugular Dual Lumen Catheter, the first such device cleared by FDA for ECMO (Extracorporeal membrane oxygenation) in the United States. MC3’s Crescent catheter is placed through the jugular vein and is connected to an ECMO system, which removes […]
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”) […]
