The Latest Cardiac and Vascular News
IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq: ELGX), a developer and marketer of innovative treatments for aortic disorders, today announced a response to the U.S. Food and Drug Administration (FDA) update regarding Type III endoleaks with the AFX Endovascular AAA System. Dr. […]
DUBLIN, Oct. 29, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Medtronic Fully Implantable Left Ventricular Assist Device […]
BAAR, Switzerland–(BUSINESS WIRE)–CorFlow Therapeutics AG (www.corflow-therapeutics.ch) today announced that the FDA has designated the company’s CoFI (CorFlow Controlled Flow Infusion) System as a “Breakthrough Device” with a broad indication-for-use statement: “The CoFI™ System is indicated for diagnostic assessment of the coronary microcirculation immediately following PCI […]
DUBLIN, Oct. 09, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced the U.S. Food and Drug Administration (FDA) has classified the company’s voluntary field action initiated in March 2019 related to the 6F Sherpa™ NX Active Coronary Guide Catheter as […]
TEWKSBURY, Mass., Oct. 9, 2019 /PRNewswire/ — Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its […]
IRVINE, Calif., Oct. 2, 2019 /PRNewswire/ — Laser Associated Sciences (LAS), a medical device company based in Irvine, California, announced that its blood flow monitoring system, FlowMet-R, received its 510(k) clearance from the Food and Drug Administration (FDA). This clearance allows LAS to market […]
MALVERN, Pa.–(BUSINESS WIRE)– The U.S. Food and Drug Administration (FDA) has cleared three modules of AI-Rad Companion Chest CT¹, an intelligent software assistant from Siemens Healthineers that brings artificial intelligence (AI) to computed tomography (CT). Representing the first intelligent assistant […]
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed’s (NASDAQ: ABMD) newest heart pump, the Impella 5.5 with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. Impella 5.5 […]
Newly cleared diagnostic test could help identify heart attacks several hours sooner than standard troponin tests and help improve diagnosis in women ABBOTT PARK, Ill., Sept. 25, 2019 /PRNewswire/ — Abbott (NYSE: ABT) today announced that its ARCHITECT STAT High Sensitivity Troponin-I blood test […]
U.S. Approval of the First and Only Nitinol Atherectomy Guide Wire Expands Company’s Portfolio of Products Targeting Complex Coronary Disease ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems […]
