The Latest Cardiac and Vascular News
On-site plant will produce DEFINITY® (Perflutren Lipid Microsphere), the leading diagnostic ultrasound enhancing agent for patients with suboptimal echocardiograms NORTH BILLERICA, Mass., Feb. 23, 2022 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated […]
CHICAGO, Feb. 15, 2022 /PRNewswire/ — Cardiosense, Inc., a Chicago-based digital health company building a physiological waveform AI platform to manage cardiac disease, announced today that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device status for its novel algorithm to identify […]
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 […]
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 […]
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 […]
– With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction(1) – Leqvio provides effective and sustained LDL-C reduction of up to 52% vs. placebo for certain […]
SILVER SPRING, Md., Dec. 21, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration authorized marketing of the first laser-based device for the removal of Inferior Vena Cava (IVC) filters. The device is designed for patients who have an IVC filter, […]
XARELTO® is available as both an oral tablet and oral suspension formulation for use in appropriate children less than 18 years of age Convenient oral suspension formulation advances standard of care for children; alleviates administration challenges found with injectable alternatives […]
SEOUL, South Korea and BETHESDA, Md., Dec. 21, 2021 /PRNewswire/ — Mezzion Pharma Co., Ltd. (Mezzion Pharma) announces that new data from its Phase 3 efficacy and safety trial (FUEL Trial) and its open label extension trial (FUEL OLE Trial) that concerns the treatment of […]
Advanced innovations leverage HeartFlow’s core AI technology and are critical additions to HeartFlow’s product portfolio for delivering complete cardiac care REDWOOD CITY, Calif., Dec. 13, 2021 (GLOBE NEWSWIRE) — HeartFlow, Inc., the leader in revolutionizing precision heart care, today announced it […]
