Tag: FDA

Medtronic Receives FDA Approval for Valiant Navion(TM) Thoracic Stent Graft System

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 […]

MC3 Cardiopulmonary Announces FDA Clearance of Crescent™ for Veno-Venous Extracorporeal Membrane Oxygenation (ECMO)

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 […]

Transseptal Solutions Announces FDA Clearance of Its Novel Transseptal Access System for Transseptal Puncture and Left Atrial Navigation

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. […]

Neovasc Reducer™ Granted Breakthrough Device Designation from FDA

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”) […]

Boston Scientific Receives U.S. FDA Approval for the Eluvia™ Drug-Eluting Vascular Stent System

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 […]

Contego Medical Receives 510(k) Clearance for the Paladin Carotid PTA Balloon System with Integrated Embolic Protection

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 […]

FDA approves device for treatment of acute coronary artery perforations

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 […]

FDA to review supplemental Biologics License Application for Praluent® (alirocumab) Injection as potential treatment to reduce major adverse cardiovascular events

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 […]

MEDTRONIC STATEMENT REGARDING RECENT FDA WARNING LETTERS

DUBLIN – September 11, 2018 – Today, Medtronic issued the following statement confirming it has received FDA warning letters (CMS #560736 and #562437) related to its Cardiac Rhythm and Heart Failure facilities located in Mounds View, Minn., and in Juncos, Puerto Rico. The warning letters reflect earlier FDA inspection reports from […]

With Latest FDA 510(k), physIQ Achieves Another Clearance as a Pioneer in AI Analytics

CHICAGO–(BUSINESS WIRE)–PhysIQ, a leader in applying AI analytics to biosensor data, today announced it has received FDA 510(k) clearance for its Atrial Fibrillation (AFib) detection analytics engine. The clearance extends physIQ’s portfolio of FDA 510(k) cleared analytics designed to generate clinical insight from wearable biosensors and further establishes physIQ as a […]