RIVANNA wins FDA clearance for BoneEnhance AI module on Accuro XV

RIVANNA said the FDA granted 510(k) clearance for BoneEnhance, a machine learning module for its Accuro XV ultrasound system. The module segments bone and surrounding tissue and overlays color-coded labels on B-mode images, with labeling accuracy of 95.1–100%.

• BoneEnhance is the first ML module cleared for the Accuro XV platform
• Anatomical labeling accuracy ranged from 95.1% to 100%
• Validation used 69,900 images from 173 subjects across five sites
• Accuro XV was cleared in April 2026 for musculoskeletal B-mode imaging