FDA Clears Artificial Intelligence Technology for 3D Skeletal Ultrasound Imaging .

Could artificial intelligence improve musculoskeletal assessment without conventional radiography? RIVANNA received FDA 510(k) clearance for BoneEnhance, a machine-learning module integrated with its Accuro XV ultrasound platform. The technology automatically identifies bone and surrounding tissues and supports 3D anatomical visualization. Validation across 233 volumetric datasets demonstrated anatomical labeling accuracy ranging from 95.1% to 100%. Although fracture-detection capabilities remain investigational, the clearance represents progress toward portable, radiation-free musculoskeletal imaging and potentially more accessible injury assessment.