FDA Clears RIVANNA BoneEnhance Software for Accuro XV

RIVANNA said in a press release that the FDA granted 510(k) clearance to BoneEnhance, a machine learning software module for its Accuro XV diagnostic ultrasound system. The software segments bone and surrounding tissue and supports three dimensional visualization of skeletal anatomy during image review.

Accuro XV automatically captures volumetric ultrasound data using a conformable three dimensional probe. BoneEnhance identifies anatomy within each volume and adds color coded overlays to the original two dimensional image without altering the underlying data. It is the first machine learning module cleared for the platform, which received clearance for musculoskeletal imaging in April 2026.

RIVANNA trained and validated BoneEnhance through an eight site clinical study. An independent test set contained 233 volumetric datasets, including 69,900 images from 173 subjects. Three board certified radiologists created the reference labels, and per-volume label prediction accuracy ranged from 95.1% to 100%.