Tag: 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 […]

FDA Designates AliveCor’s Bloodless Hyperkalemia Test a “Breakthrough Device”

MOUNTAIN VIEW, Calif., Sept. 10, 201 /PRNewswire/ — AliveCor, recently recognized as the Most Innovative Company in Artificial Intelligence, today announced that the U.S. Food and Drug Administration has given the company’s KardiaK Software Platform the rarely granted designation of “Breakthrough Device.” This designation means that the FDA will consider the technology […]

Cook Medical Announces Successful Resolution of 2014 FDA Warning Letter

BLOOMINGTON, Ind.–(BUSINESS WIRE)–Cook Medical today announced that it received a close-out letter from the U.S. Food and Drug Administration resolving a 2014 warning letter for processes related to the quality system at the company’s manufacturing facility in Bloomington, Indiana. The resolution was a direct result of countless hours of hard […]

Avinger Announces 510(k) Filing of Pantheris Small Vessel Device

REDWOOD CITY, Calif., Aug. 30, 2018 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced the Company submitted a new 510(k) application to the U.S Food & Drug Administration (FDA) for the Pantheris SV (Small Vessel) Lumivascular atherectomy system. Pantheris […]

Medicure Announces FDA Approval of Acute Care Cardiovascular Drug Sodium Nitroprusside Injection

WINNIPEG, Aug. 13, 2018 /PRNewswire/ – Medicure Inc. (“Medicure” or the “Company”) (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, is pleased to announce that the United States Food and Drug Administration (“FDA”) has approved its Abbreviated New Drug Application (“ANDA”) for Sodium Nitroprusside Injection 50 mg/2 mL (25 mg/mL) single dose vial (“SNP”), […]