The Latest Cardiac and Vascular News
SEOUL, South Korea, Feb. 21, 2023 /PRNewswire/ — Mezzion Pharma Co., Ltd. (Mezzion Pharma) has submitted a confirmatory pivotal Phase 3 Clinical Trial in Fontan subjects to the Food and Drug Administration (FDA). In the Type B meeting between the FDA and Mezzion, the FDA provided Mezzion with a clear path forward […]
Irish-based company secures first U.S. regulatory clearance for its Millipede 088 Access Catheter from the Food and Drug Administration (FDA) The company is also developing catheter-based technology for treating acute ischemic stroke GALWAY, Ireland–(BUSINESS WIRE)–Perfuze, a medical device company developing next-generation catheter-based technology to treat acute ischemic stroke, has secured […]
Latest Swoop® software improves image quality for DWI imaging of the brain GUILFORD, Conn., Feb. 13, 2023 (GLOBE NEWSWIRE) — Hyperfine, Inc., the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. […]
The primary endpoint is the proportion of patients with a good outcome as a modified Rankin Score (mRS) of 0-2 on day 90 post-randomization Sovateltide is an endothelin-B receptor agonist that has been shown to increase blood flow, inhibit apoptosis, and induce neurovascular remodeling WILLOWBROOK, III., Feb. 13, 2023 /PRNewswire/ — Pharmazz, […]
Novel technology shows potential to treat heart failure—leading cause of hospitalizations worldwide—with less invasive approach January 26, 2023 09:00 AM Eastern Standard Time AUSTIN, Texas–(BUSINESS WIRE)–Alleviant Medical, Inc., a privately-held medical device company developing a no-implant interatrial shunt for heart failure, today announced the closing of a $75 million equity […]
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 […]
