The Latest Cardiac and Vascular News
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sublime™ guide sheath. The highly flexible, proprietary Xtreme® braid-reinforced Sublime sheath is designed to resist kinking […]
MOUNTAIN VIEW, Calif., April 23, 2019 /PRNewswire/ — AliveCor, the leader in FDA-cleared consumer electrocardiogram technology (ECG), today announced two additional FDA 510(k)-cleared indications, making KardiaMobile the only consumer ECG device in the world with FDA-clearance to detect the three most common heart arrhythmias. In addition to detecting Atrial Fibrillation (AFib) and Normal Sinus […]
BURLINGTON, Mass.–(BUSINESS WIRE)–Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary artery disease, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the indications for use for its Makoto™ Intravascular Imaging System. The approval is based on the […]
PARIS and NEW YORK, April 17, 2019 (GLOBE NEWSWIRE) — Quantum Genomics (Euronext Growth: ALQGC, OTCQX: QNNTF), a biopharmaceutical company specializing in the development of a new drug class that directly targets the brain to treat resistant hypertension and heart failure, today announced the first regulatory and ethics approvals for its Phase […]
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a private medical device company committed to developing solutions for minimally invasive peripheral vascular procedures, today announced it received U.S. Food and Drug Administration (FDA) approval for the Tack Endovascular System (6F), a purpose-built dissection repair device implanted post-angioplasty in patients with peripheral arterial disease (PAD). […]
REDWOOD CITY, Calif., April 10, 2019 (GLOBE NEWSWIRE) — Avinger, Inc. (Nasdaq: AVGR), a leading developer of image-guided, catheter-based systems for the diagnosis and treatment of patients with Peripheral Artery Disease (PAD), today announced that the Company received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its […]
IRVINE, Calif.–(BUSINESS WIRE)–TherOx, Inc., a privately held medical device company focused on improving treatment of acute myocardial infarction (AMI), announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for its SuperSaturated Oxygen (SSO2) Therapy. SSO2 Therapy provides interventional cardiologists with the first and only FDA-approved treatment beyond percutaneous […]
WASHINGTON, March 27, 2019 /PRNewswire/ — Alliance for Aging Research, Association of Black Cardiologists, Heart Valve Voice US, and Mended Hearts issued a joint statement today in response to the Centers for Medicare and Medicaid Services’ proposed decision to cover Transcatheter Aortic Valve Replacement for the treatment of symptomatic aortic valve stenosis through […]
MASON, Ohio–(BUSINESS WIRE)–Genetesis, a medical technology company focused on using biomagnetic imaging to enable rapid, noninvasive and accurate chest pain triage, has received FDA 510(k) clearance for its cardiac imaging platform. The platform pairs the CardioFlux™ Magnetocardiograph with the integrated Faraday Analytical Cloud™ (FAC). “This milestone provides emergency room physicians […]
FRANKLIN LAKES, N.J., March 21, 2019 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued the following statement related to the recent letter from FDA to health care providers regarding paclitaxel-coated devices: On March 15, the FDA issued a letter to health care providers regarding paclitaxel-coated devices […]
