The Latest Cardiac and Vascular News
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 […]
– sNDA Submission is Based on Findings from the APOLLO-B Phase 3 Study That Showed Patisiran Demonstrated Significant Improvement on Functional Capacity, Health Status and Quality of Life Compared to Placebo at Month 12 – – Study Also Demonstrated Encouraging Safety Profile in Patients with Cardiomyopathy of ATTR Amyloidosis – […]
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 […]
Approval marks second clinical trial approved by FDA this year for Company’s NK1R+ MSC platform Allogeneic CardiALLO therapy for heart failure to complement autologous cell therapy currently enrolling in Phase III CardiAMP Heart Failure clinical trial SUNNYVALE, Calif.–(BUSINESS WIRE)–BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment […]
New AI device expands Diagnostics as a Service platform capabilities. NEW YORK , Dec. 5, 2022 /PRNewswire/ — Imagen Technologies, Inc. announced the U.S. Food and Drug Administration’s 510(k) clearance of the computer-assisted detection (CADe) device Aorta-CAD. This new, FDA cleared device is designed to assist physicians at detecting findings on chest X-rays that […]
If approved, Evkeeza would be the first and only treatment of its kind to help children as young as 5 years old control dangerously high levels of LDL cholesterol caused by homozygous familial hypercholesterolemia TARRYTOWN, N.Y., Nov. 30, 2022 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has […]
