The Latest Cardiac and Vascular News
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 the first and only phosphate absorption inhibitor, offering patients a […]
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 WIRE)–Owlet, Inc. (NYSE: OWLT) (the “Company”) announces that the U.S. […]
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 with the same objective as for the recent meeting with the […]
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 trial. Amir Kaki, MD, director of mechanical circulatory support at […]
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 has submitted a New Drug Application (NDA) to the US […]
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 of Valo’s Biowire platform to predict clinical efficacy of Cardiac […]
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 the U.S. Food & Drug Administration (FDA) Cardiovascular and Renal […]
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 has halted the trading of the Company’s common stock. The […]
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 innovative interventional treatments for vascular disease, today announced that it […]
EchoGo® Heart Failure revolutionizes the detection of HFpEF – the biggest unmet need in cardiovascular medicine.1 OXFORD, England, Dec. 6, 2022 /PRNewswire/ — Ultromics’ EchoGo® Heart Failure, an AI solution for echocardiography with the potential to revolutionize the diagnosis of heart failure with preserved ejection fraction (HFpEF), has received US Food and Drug […]
