The Latest Cardiac and Vascular News
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 […]
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 […]
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) […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Patient death prompts safety warning by FDA. Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication – Potential Lack of Treatment (Shock) Delivery Due to Device Failure by FDA.gov ISSUE: FDA is providing information and recommendations regarding the Zoll LifeVest […]
