The Latest Cardiac and Vascular News
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 […]
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) […]
WASHINGTON, Feb. 13, 2023 /PRNewswire/ — MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance, and Japan Distribution […]
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, […]
WATERBURY, Conn., Feb. 06, 2023 (GLOBE NEWSWIRE) — Northeast Scientific Inc., the pioneers in reprocessing single use peripheral vascular catheters, announced this week it has received FDA 510(k) clearance for reprocessing the Philips IVUS Eagle Eye Platinum RX Digital catheter. […]
DiA Imaging Analysis’s LVivo IQS, a vendor-neutral AI-powered software provides cardiac ultrasound users with real-time image quality feedback while scanning BEER SHEVA, Israel, Feb. 6, 2023 /PRNewswire/ — DiA Imaging Analysis, a leading provider of advanced AI-based software solutions for ultrasound image analysis, […]
SCHAFFHAUSEN, CH / ACCESSWIRE / January 31, 2023 / Occlutech Holding AG Occlutech Holding AG (“Occlutech”), one of the world’s leading providers of minimally invasive structural heart disease devices, continues its progress in the US market. The first patient has […]
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 […]
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 […]
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 […]
