The Latest Cardiac and Vascular News
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 I recalls describe situations where there is reasonable risk of […]
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. stents are the first and only stents PMA approved for […]
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 FDA clearance at the end of 2017. This clearance gives […]
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 its next generation Pantheris® Lumivascular atherectomy system, the first-ever image-guided […]
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 retriever used to capture and remove life-threatening blood clots from […]
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 balloon design of the company’s FDA-approved HeartLight® Endoscopic Ablation System and introduces an […]
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, capturing and analyzing data in a novel manner to create […]
Menlo Park, Calif. – May 1, 2018 – iSchemaView, the leader in cerebrovascular imaging analysis, today announced it has received final clearance from the U.S. Food and Drug Administration (FDA) for RAPID CTA, the company’s 3D imaging solution for Computed Tomography Angiography. RAPID CTA is the newest addition to iSchemaView’s industry […]
CHERRY HILL, N.J. and ALLSCHWIL, Switzerland, April 30, 2018 /PRNewswire/ — Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of OPSUMIT (macitentan) to include the treatment […]
TORONTO–(BUSINESS WIRE)– Conavi TM Medical Inc. (www.conavi.com) is pleased to announce that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its NovasightTM Hybrid System. The system enables simultaneous imaging of coronary arteries with both intravascular ultrasound (IVUS) and Optical Coherence Tomography (OCT). IVUS or OCT are typically […]
