The Latest Cardiac and Vascular News
– First Patient Treated with Zoom RDL at Spectrum Health – – Newest Addition to Company’s Zoom Stroke Solution Provides an Additional Option for Achieving Intracranial Access to Treat Patients for Ischemic Stroke – CAMPBELL, Calif.–(BUSINESS WIRE)–Imperative Care, Inc., today announced U.S. […]
Office of New Drugs directs the Division of Cardiology and Nephrology to work with Ardelyx to develop a label to support the commercialization of XPHOZAH; Ardelyx to resubmit NDA in the first half of 2023 Upon approval, XPHOZAH would be […]
Owlet submitted a de novo classification request to the FDA for an over-the-counter software-as-a-medical-device that offers heart rate and oxygen displays and notifications in conjunction with Owlet’s existing Dream Sock sleep monitoring capabilities. December 22, 2022 04:05 PM Eastern Standard Time LEHI, Utah–(BUSINESS […]
PARIS–(BUSINESS WIRE)–Regulatory News: Acticor Biotech, (ISIN: FR0014005OJ5 – ALACT) (Paris:ALACT), a clinical stage biopharmaceutical company developing glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, is discussing with FDA to set up a Type C meeting for early 2023 […]
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) announces the United States Food and Drug Administration (FDA) has approved the version of Impella ECP that will be used in the Impella ECP Pivotal Trial, and the first two patients have been enrolled in the […]
The application includes data from the Phase 3 registration study of patients with resistant hypertension, where aprocitentan demonstrated a sustained blood pressure reduction over 48 weeks and was well-tolerated Allschwil, Switzerland – December 20, 2022 Idorsia Ltd (SIX: IDIA) today announced that it […]
Findings Part of Five-Year Research Collaboration Between Valo and FDA Developed on Valo’s Biowire Platform BOSTON, Dec. 14, 2022 /PRNewswire/ — Valo Health, Inc (“Valo”) shared the initial results of a collaborative study with the U.S. Food and Drug Administration (FDA), demonstrating the potential […]
PDUFA Target Action Date is February 28, 2023 Cytokinetics to Host Conference Call and Webcast on December 14, 2022 at 8:30 am Eastern Time SOUTH SAN FRANCISCO, Calif., Dec. 13, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that […]
FDA Advisory Committee to Review the New Drug Application for Omecamtiv Mecarbil for the Treatment of Heart Failure with Reduced Ejection Fraction SOUTH SAN FRANCISCO, Calif., Dec. 13, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Nasdaq […]
The AFX2 Endovascular AAA System integrates anatomical fixation with an advanced delivery system to facilitate treatment of patients with abdominal aortic aneurysm (AAA). IRVINE, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held global medical device company, dedicated to improving patients’ lives with […]
