This article was originally covered by AuntMinnie. Please follow this link: AZmed nets FDA clearance for x-ray AI system
AZmed and Radin Health are expanding their strategic partnership following AZmed's third 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the AZtrauma module of its Rayvolve AI Suite.
This clearance expands coverage to include joint effusions and dislocations alongside fracture detection on x-rays in adult and pediatric patients aged two and older. It follows publication of a clinical validation study using over 258,000 x-rays from 100 clinical centers across 26 countries.
AZtrauma and AZchest, AZmed's thoracic abnormality triage module, are integrated into Radin Health's cloud-based RIS/PACS platform, with AI-generated structured reporting data feeding directly into Radin's system.
