The Latest Cardiac and Vascular News
PDUFA Target Action Date Set for November 30, 2022 FDA is Currently Not Planning to Hold an Advisory Committee Meeting to Discuss the Application SOUTH SAN FRANCISCO, Calif., Feb. 04, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food & Drug Administration (FDA) has accepted and […]
SUNNYVALE, Calif.–(BUSINESS WIRE)–BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP® Cell Therapy System for the treatment of heart failure. It is believed […]
AliveCor launches KardiaMobile Card, the only personal ECG slim enough to fit in a wallet for instant feedback on heart health anytime, anywhere MOUNTAIN VIEW, Calif., Feb. 1, 2022 /PRNewswire/ — AliveCor, the leading innovator in FDA-cleared personal electrocardiogram (ECG) technology, today announced the launch of KardiaMobile Card, the slimmest, most convenient personal […]
LAS VEGAS–(BUSINESS WIRE)–AIROS Medical, Inc., a designer, manufacturer, and distributor of compression therapy devices, and Fist Assist Devices, LLC (Fist Assist), an innovative medical device company, today announced the launch of an e-commerce website, www.fistassistusa.com, for the sale of the Fist Assist FA-1 compression device. The FDA 510(k)-cleared Fist Assist Model FA-1 […]
Expanding patient base and potential of Imara’s small molecule oral inhibitor of phosphodiesterase-9 (PDE9) alongside hemoglobin disorders Phase 2 trial aims to select HFpEF patients with enriched PDE9 expression for targeted approach to a heterogeneous disease Study initiation planned for second quarter of 2022 BOSTON, Jan. 25, 2022 (GLOBE NEWSWIRE) […]
WILMINGTON, Del., January 24, 2022 – Eplontersen has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of transthyretin-mediated amyloidosis, a systemic, progressive and fatal condition. Eplontersen, formerly known as IONIS-TTR-LRx, is a ligand-conjugated antisense (LICA) investigational medicine currently in […]
Bloomington, Ind. — Cook Medical has received Breakthrough Device designation from the US Food and Drug Administration (FDA) on a new drug-eluting stent for below the knee (BTK). This new stent is designed to treat patients suffering from chronic limb-threatening ischemia (CLTI). “CLTI is a debilitating disease of growing prevalence around […]
ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today, along with OrbusNeich Medical Company Ltd (OrbusNeich®), announced FDA PMA approval of OrbusNeich’s Scoreflex® NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter […]
– External device uses heart sound and AI to deliver rapid cardiac function assessments via tablet to expand hemodynamic evaluation beyond the Cath lab – LOS ANGELES–(BUSINESS WIRE)–Sensydia, an innovator in rapid, non-invasive measurement of critical cardiac function, today announced that its Cardiac Performance System (CPSTM) has been granted Breakthrough Device Designation by the […]
Live Case will be Broadcasted Today at 11:00am ET TEL AVIV, Israel, Jan. 18, 2022 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for prevention of stroke caused by Carotid Artery Disease (CAD), today announced that a live case demonstration featuring CGuard™ […]
