Regulatory

Surmodics Announces FDA Clearance of a New .018” Low-Profile PTA Balloon Dilation Catheter

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its .018” Low-Profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed and indicated for a broad […]

Medtronic IN.PACT(TM) Admiral(TM) Drug Coated Balloon Receives FDA Approval to Treat Long SFA Lesions

DUBLIN – April 23, 2018 – Medtronic plc (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the IN.PACT(TM) Admiral(TM) Drug-Coated Balloon (DCB) to treat long superficial femoral artery (SFA) lesions up to 360mm in patients with peripheral artery disease (PAD). Approval was based […]

Tinton Falls Company Gets FDA Approval For Early Heart Attack Detection Device

Angel Medical Systems, Inc. of Tinton Falls announced that they have received FDA pre-market approval on a medical device that detects heart attacks before patients experience symptoms. The AngelMed Guardian System is an implantable heart monitor with internal and external alerting capabilities to urge at-risk patients with pre-existing cardiac conditions […]

HeartStitch® Inc. has received CE Mark for Its Suture Based Trans-Apical Access and Closure

ZWICKAU, Germany, April 12, 2018 /PRNewswire/ — HeartStitch® Trans-Apical Access and Closure device provides safe and effective percutaneous trans-apical access for structural heart procedures and reliable closure. The proven suture-based technique emulates surgical closure without the need for open heart surgery or limited thoracotomy access (open surgical access to the heart between the ribs) when […]

Abbott’s MitraClip Therapy Receives National Reimbursement in Japan to Treat Patients with Mitral Regurgitation

ABBOTT PARK, Ill., March 19, 2018 /PRNewswire/ — Abbott (NYSE: ABT) today announced that the Ministry of Health Labour and Welfare (MHLW) in Japan granted national reimbursement for the company’s MitraClip therapy to treat people with mitral regurgitation, a serious, progressive heart disease in which the mitral valve does not close properly, […]

Neovasc Announces Receipt of German NUB Status 1 Designation for Neovasc Reducer™ Procedure for Treatment of Refractory Angina

Participating Hospitals in Germany Now Eligible to Negotiate Reimbursement for Reducer Procedure NASDAQ, TSX: NVCN VANCOUVER, Feb. 1, 2018 /PRNewswire/ – Neovasc, Inc. (NVCN) (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve technologies, today announced that the “Institut für das Entgeltsystem im […]

FDA Grants RMAT Designation For Mesoblast’s Cell Therapy in Heart Failure Patients With LVADs

NEW YORK and MELBOURNE, Australia, Dec. 21, 2017 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO) (ASX:MSB) today announced that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for its novel mesenchymal precursor cell (MPC) therapy in the treatment of heart failure patients with left ventricular […]

XableCath Scores FDA Clearance for Broadly Effective Catheter

SALT LAKE CITY–(BUSINESS WIRE)– XableCath, a clinical stage medical device company, announced its XableCath blunt tip support catheter has received clearance from the FDA. The blunt tip catheter facilitates true lumen passage of lesions, both above and below the knee, in the peripheral vasculature. Procedures using the XableCath blunt tip catheters can […]

FDA Approves Amgen’s Repatha® (evolocumab) To Prevent Heart Attack And Stroke

THOUSAND OAKS, Calif., Dec. 1, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that following priority review of its supplemental Biologics License Application, the U.S. Food and Drug Administration (FDA) approved Repatha® (evolocumab) as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease.1 “We are pleased […]