Regulatory

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 […]

Boston Scientific Prevails in German Edwards Lifesciences Litigation

MARLBOROUGH, Mass., Oct. 23, 2018 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced the District Court of Dusseldorf, Germany has determined that Edwards Lifesciences Corporation’s Sapien 3 Ultra™ device infringed a patent – established by Symetis SA, a subsidiary of Boston Scientific – specific to the fabric used on the […]

Correvio Announces Intention to Re-File Brinavess® NDA in Second Quarter 2019

VANCOUVER, Oct. 23, 2018 /PRNewswire/ – Correvio Pharma Corp. (NASDAQ: CORV /TSX: CORV), a specialty pharmaceutical company focused on providing high-quality brands to acute care physicians and patients, today announced that, based on productive pre-NDA discussions with the U.S. Food and Drug Administration (FDA), Correvio plans to resubmit the Brinavess® […]

ABBOTT’S HEARTMATE 3 HEART PUMP NOW FDA APPROVED FOR ADVANCED HEART FAILURE PATIENTS NOT ELIGIBLE FOR A HEART TRANSPLANT

ABBOTT PARK, Ill., Oct. 19, 2018 /PRNewswire/ — Abbott (NYSE: ABT) announced today that the HeartMate 3™ Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as a destination therapy for people living with advanced heart failure. With the approval, physicians can now offer the HeartMate 3 system to patients not […]

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”) […]

PureFlow is a breakthrough technology in non-invasive cardiology and sports recovery; is now FDA 510K and MDD 93/42/ EEC cleared

NEW YORK, Oct. 2, 2018 /PRNewswire/ — Xtreem Pulse LLC is pleased to announce that PureFlow received 510Kclearance from the FDA for chronic stable angina that is refractory to optimal anti-anginal medical therapy and without option for revascularization. Intended for use in healthy patients to provide improvement in vasodilation, increased VO2, and increased […]

CathVision Receives ISO 13485:2016 Certification

COPENHAGEN, Denmark, October 2, 2018 /PRNewswire/ — CathVision ApS, an early stage medical device company developing an advanced cardiac electrophysiology recording system, CUBE, announced today that the company received ISO 13485:2016 certification for Medical Device and Quality Management Systems from Lloyd’s Register. This ISO certification indicates that the company’s quality management system meets the […]

BIOSENSE WEBSTER ANNOUNCES FIRST PATIENTS ENROLLED IN POST-MARKET APPROVAL STUDY FOR ITS NOVEL TAG-INDEX GUIDED SOFTWARE

IRVINE, Calif., SEPTEMBER 26 – Johnson & Johnson Medical Devices Companies* announced today that Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of heart arrhythmias, has received approval from the U.S. Food and Drug Administration (FDA) for its VISITAG SURPOINT External Processing Unit and enrollment has begun […]