AZmed gets FDA clearance for expanded AZtrauma scope

AZmed has received its 3rd FDA clearance for AZtrauma, expanding the AI tool’s U.S. scope to include joint effusions and dislocations on X-rays, according to the company.

The solution is now cleared for fracture, joint effusion, and dislocation detection across adult and pediatric patients ages 2 years and older, AZmed said.

Earlier FDA clearances covered fracture detection. Rayvolve received 510(k) clearance for adult fracture detection under K220164 in 2022 and for adult and pediatric fracture detection under K240845 in 2024.

FDA documentation for K240845 describes Rayvolve as computer-assisted detection and diagnosis software to assist radiologists and emergency physicians in detecting fractures during review of musculoskeletal radiographs. The indication covers adult and pediatric patients ages 2 years and older.

AZtrauma is part of AZmed’s Rayvolve AI Suite for X-ray imaging. The company said the expanded clearance makes AZtrauma the only FDA-cleared AI solution in the U.S. covering fractures, joint effusions, and dislocations on X-rays.

AZmed’s clinical evidence page reports multicenter performance for AZtrauma, including overall AUC of 98.3%, sensitivity of 97.4%, and specificity of 96.4%. The same summary reports AUC values of 98.7% for fractures, 95.6% for dislocations, and 97.5% for joint effusions.

AZmed referenced regulatory information MM-26-23 in its announcement.