GE Healthcare Technologies Inc. received U.S. FDA approval for its novel radiotracer, Flyrcado (flurpiridaz F-18), for use in the diagnosis of myocardial ischemia or infarction in patients with known or suspected coronary artery disease. Read More
The Pi-Cardia Ltd. Shortcut — the catheter-based, leaflet modification solution for treating heart valves — received U.S. FDA clearance. The device was granted breakthrough device designation from the regulatory agency and is designed to split bioprosthetic aortic valve leaflets in patients undergoing valve-in-valve transcatheter aortic valve replacement (TAVR) procedures who are at risk of coronary obstruction. Read More
The U.S. FDA has guidances on the books for dental products, but the it unleashed a quartet of guidances – ceramics and cements used in dental procedure – for dental products on the final Friday of September 2024. The agency also issued a guidance without comment – unusual for the FDA – for the well-known, terror-striking pneumatic dental hand tool. Read More
The question of how to define artificial intelligence (AI) for medical product usage was answered by the FDA, which recently offered an AI glossary. Read More
Cereno Scientific AB’s positive top-line results from the phase IIa trial of histone deacetylase inhibitor CS1 in pulmonary arterial hypertension provide a “clear path forward” in the debilitating, fatal disease, the company said. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ascend Imaging, Cortechs.ai, Daxor, Memed, Owlstone, Spire Health, Wellinks . Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accelerate Diagnostics, GE Healthcare, Pi-Cardia, Siemens Healthineers . Read More
