The Latest Cardiac and Vascular News
Treatment IDE Will Provide Opportunity to Treat Additional Patients in the US SAN RAMON, Calif., Jan. 24, 2023 /PRNewswire/ — BioVentrix®, Inc., a privately held medical device company focused on the development of less invasive therapies to directly treat the dilated left ventricle and reverse the left ventricular remodeling process of progressive heart […]
FDA-cleared and clinically-validated app lets Venu 2 Plus customers record an ECG and check for signs of atrial fibrillation right from their smartwatch OLATHE, Kan., Jan. 24, 2023 /PRNewswire/ — Garmin (NYSE: GRMN) today announced the ECG App1, an FDA-cleared app for the Venu® 2 Plus smartwatch that allows users to record their heart rhythm and check […]
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced it has received a letter from the U.S. Food and Drug Administration (FDA; the Agency) related to its premarket approval (PMA) application for the SurVeil™ drug-coated […]
Abbott’s new Navitor device features advancements to improve patient care, including reducing or eliminating risk of blood leakage around valve implant Transcatheter aortic valve implantation (TAVI) offers minimally invasive alternative to surgery for people with aortic stenosis, a common and life-threatening heart valve disease ABBOTT PARK, Ill., Jan. 17, 2023 /PRNewswire/ — […]
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 […]
