The Latest Cardiac and Vascular News
Stratford-upon-Avon, UK, 08 June 2018 – Celixir, a privately owned company discovering and developing life-saving advanced therapies, announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug application (IND) for HeartcelTM, its immuno-modulatory progenitor (iMP) cell […]
WALTHAM, Mass.–(BUSINESS WIRE)–Corindus Vascular Robotics, Inc. [NYSE American: CVRS], a leading developer of precision vascular robotics, announced today that it received Pharmaceutical and Medical Device Agency (PMDA) Approval for commercialization of its CorPath® GRX System in Japan. Japan is one of […]
MALVERN, Pa.–(BUSINESS WIRE)–The Food and Drug Administration (FDA) has cleared the Biograph Vision, a new positron emission tomography/computed tomography system from Siemens Healthineers that delivers a new level of precision in PET/CT imaging. The Biograph Vision features new Optiso Ultra […]
DUBLIN – June 1, 2018 – The United States Food and Drug Administration (FDA) has classified Medtronic plc’s (NYSE: MDT) recent voluntary urgent field action related to the HeartWare(TM) HVAD(TM) System unexpected power source switching as a Class I recall. Class […]
ALISO VIEJO, Calif., May 31, 2018 /PRNewswire/ — MicroVention, Inc., a U.S.-based subsidiary of Terumo and a global neurovascular company, announced today the FDA Premarket Approval (PMA) for the LVIS® and LVIS® Jr. stents for stent-assisted coil embolization of intracranial aneurysms. The LVIS® and LVIS® Jr. […]
SALT LAKE CITY–(BUSINESS WIRE)–XableCath, Inc., innovators of products designed to aid in the treatment of peripheral artery disease (PAD), announced that its second catheter, XableCath™ abrasion tip support catheter, was cleared by the FDA. The XableCath blunt tip catheter received […]
REDWOOD CITY, Calif., May 23, 2018 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), announced today that the Company received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for […]
IRVINE, Calif., May 21, 2018 /PRNewswire/ — CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EMBOTRAP II Revascularization Device, a next generation stent […]
MARLBOROUGH, Mass., May 7, 2018 /PRNewswire/ — CardioFocus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of paroxysmal atrial fibrillation (PAF)*. The Excalibur Balloon leverages the proven universal […]
ABBOTT PARK, Ill., May 3, 2018 /PRNewswire/ — Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) clearance of the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™. Advisor HD Grid employs a new design that allows physicians to see things differently, […]
