The Latest Cardiac and Vascular News
NEW HOPE, Pa., April 24, 2019 (GLOBE NEWSWIRE) — Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing advanced therapeutic solutions to address major unmet healthcare needs, announced today that it has secured Breakthrough Device designation by […]
MARLBOROUGH, Mass., April 23, 2019 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the LOTUS Edge™ Aortic Valve System. Delivered via a minimally-invasive procedure, this transcatheter aortic valve replacement (TAVR) technology is approved […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
