RIVANNA's Accuro XV AI musculoskeletal ultrasound receives FDA 510(k) clearance

The FDA granted 510(k) clearance to RIVANNA's Accuro XV, a portable point-of-care volumetric ultrasound system for musculoskeletal imaging. The system uses a conformable 3D probe to automate large field-of-view image acquisition without ionizing radiation. AI modules in development include BoneEnhance (bone segmentation/3D visualization) and CADe/x (first computer-aided fracture detection from volumetric ultrasound), being validated through a multi-site clinical study across eight US academic medical centers. A 205-patient feasibility study showed over 90% of scans by non-physician operators after one hour of training were diagnostically adequate.