Charlottesville, Virginia-based medical technology company RIVANNA has announced FDA 510(k) clearance for BoneEnhance, a machine learning module for its Accuro XV ultrasound system. Announced October 22, 2026, the clearance adds automated anatomical labeling to a platform already authorized for musculoskeletal ultrasound imaging, advancing the company’s effort to bring more imaging capabilities closer to the point of care.
Building on an Earlier FDA Clearance
The new software identifies bone and surrounding tissues in volumetric ultrasound scans and displays color-coded overlays during image review. A three-dimensional orientation indicator helps clinicians understand where an image slice falls within the scan. The original ultrasound image remains visible beneath the labels. The milestone follows the FDA’s April 9 clearance of the underlying Accuro XV system, which RIVANNA announced in May. BoneEnhance is cleared to assist anatomical visualization, not to independently diagnose fractures.
Validation Across Multiple Clinical Sites
Three sites supplied training data and five other sites supplied an independent test set comprising 233 volumetric datasets, 69,900 images and 173 subjects. The company reported per-volume anatomical label prediction accuracy ranging from 95.1% to 100%. Those figures measure labeling performance rather than the ability to diagnose an injury, an important distinction as the company develops additional software. Separately, a peer-reviewed study involving 205 patients examined whether minimally trained operators could acquire usable wrist and ankle ultrasound images with Accuro XV. That study addressed image acquisition, not BoneEnhance’s diagnostic performance.
Federal Support and Virginia Research Connections
The development program has received support from the Biomedical Advanced Research and Development Authority (BARDA). RIVANNA expanded its clinical program from two to eight sites in April following a BARDA funding option and now reports ten participating sites. The Virginia connection extends beyond the company’s headquarters: the published Accuro XV image-acquisition study includes researchers affiliated with UVA Health in Charlottesville. The FDA’s record for Accuro XV also identifies RIVANNA’s applicant address in Charlottesville.
Fracture Detection Remains the Next Regulatory Challenge
RIVANNA is developing a separate investigational module intended to help clinicians identify potential extremity fractures and support triage decisions. Injury-detection software has not received FDA clearance and is not available for sale. For Virginia’s medtech ecosystem, the BoneEnhance decision marks a concrete regulatory step toward more software-assisted ultrasound workflows. Whether the platform can ultimately improve fracture detection or reduce unnecessary X-ray referrals will require further clinical evidence and regulatory review.
