The Latest Cardiac and Vascular News
Company Prepares for US Commercial Launch PRAIRIE VILLAGE, Kan., March 22, 2022 /PRNewswire/ — Artio Medical, Inc., a medical device company developing innovative products for the peripheral vascular, neurovascular, and cardiology markets, today announced it received US Food and Drug Administration (FDA) clearance for its Solus Gold Embolization Device, a next-generation product for peripheral vascular […]
– Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death and hospitalization for heart failure, regardless of ejection fraction – FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. with heart failure with preserved ejection fraction, […]
SILVER SPRING, Md., Feb. 24, 2022 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Jardiance was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control […]
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 provider committed to innovative imaging diagnostics, targeted therapeutics and artificial […]
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 patients at risk of decompensated heart failure. The algorithm analyzes […]
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 […]
– 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 people with atherosclerotic cardiovascular disease (ASCVD) on maximally tolerated statin […]
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, a small cage-like device inserted into the largest vein in […]
