The Latest Cardiac and Vascular News
GENEVA, Jan. 10, 2023 /PRNewswire/ — SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of coronary de novo lesions. This comes less than eight months after the company received its first IDE approval for SELUTION SLR in the treatment […]
CardiacSense was granted FDA clearance for Beat-by-Beat Heart Rate, and Oxygen Saturation (SpO2) Proprietary sensors enable highly accurate and reliable measurement of vital signs (99% sensitivity and specificity for beat-by-beat heart rate when comparted to Holter Monitor) CardiacSense plans to file additional indications during 2023 and has already gathered much […]
PETAH TIKVA, Israel, Jan. 9, 2023 /PRNewswire/ — Biobeat, a global leader in wearable remote patient monitoring solutions for the healthcare continuum, announced today that its wearable remote patient monitoring devices have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to monitor stroke volume and cardiac output in addition to cuffless […]
System includes mechanical and aspiration thrombectomy devices to treat peripheral vascular disease ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that Innova Vascular, Inc. (Innova) has submitted a […]
– 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. Food and Drug Administration (FDA) 510(k) clearance of its Zoom™ […]
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 […]
