FDA clears BoneEnhance, first machine learning layer for RIVANNA's Accuro XV
The U.S. Food and Drug Administration has granted 510(k) clearance for BoneEnhance, a machine learning software module for RIVANNA's Accuro XV diagnostic ultrasound system. According to the company, it is the first machine learning module cleared for the platform and moves it from image acquisition toward interpretation.
- FDA granted 510(k) clearance for BoneEnhance, a machine learning module for the Accuro XV ultrasound system.
- BoneEnhance segments bone and surrounding tissues and shows skeletal anatomy in 3D, with color-coded overlays on B-mode images.
- The independent test set had 233 volumetric datasets from 173 subjects, with per-volume label accuracy of 95.1% to 100.0%.
- An investigational injury detection module for extremity fractures is in development, and the study has grown from eight to ten sites.
What BoneEnhance does
BoneEnhance segments bone and surrounding tissues and supports three-dimensional visualization of skeletal anatomy during image review, according to RIVANNA. Accuro XV uses a conformable three-dimensional probe that automates large field-of-view image acquisition once the patient has been positioned. Each automated acquisition creates a volumetric dataset.
Within that volume, BoneEnhance identifies bone and surrounding tissues and highlights them with color-coded overlays on the two-dimensional B-mode image. The original anatomical data remain unaltered and visible beneath the overlays. A three-dimensional indicator next to the image shows the scan orientation and where the displayed slice sits within the volume.
Accuro XV itself was cleared in April 2026 for B-mode imaging in musculoskeletal conventional and superficial applications. The company describes it as a portable, small-footprint point-of-care system that works without ionizing radiation.
Validation data
RIVANNA says BoneEnhance was trained and validated within its nationwide eight-site clinical study. Three sites provided the training data. The other five supplied an independent test set of 233 volumetric datasets, comprising 69,900 images from 173 subjects. According to the company, none of the test data were used for training or tuning.
Three board-certified radiologists established the reference labels. Per-volume label prediction accuracy, which the company describes as a measure of anatomical labeling, ranged from 95.1% to 100.0%.
RIVANNA also points to separate peer-reviewed evidence on the acquisition side, which is not part of the validation supporting this clearance. In a published study of 205 patients in the Journal of Emergency Medicine, operators with one hour of hands-on training acquired wrist and ankle images rated adequate for diagnostic interpretation in more than 90% of scans. Image quality was comparable to physician-acquired scans.
Injury detection module in development
The next step on the roadmap is an investigational musculoskeletal injury detection module. Where BoneEnhance labels anatomy, the new module is being developed to help clinicians evaluate potential extremity fractures within acquired ultrasound images. RIVANNA says it is designed to annotate soft-tissue signs associated with injury and to support triage decisions, including referral for additional radiographic imaging. It is not cleared.
The clinical study that trained and validated BoneEnhance has been expanded from eight to ten sites and is building the datasets for the new module. The company says the sites and data infrastructure are reused for each new module, so every subsequent module builds on the program's federal investment. The project was supported with funds from the U.S. Department of Health and Human Services, ASPR and BARDA under contract number 75A50121C00035.
What it means
For clinicians using or considering Accuro XV, the clearance adds software-assisted review to an acquisition workflow that was already automated. CEO Will Mauldin called the clearance "the foundation: the first machine learning layer, anchoring the decision-support capabilities now in development."
RIVANNA says Accuro XV is designed to provide a fracture-care layer at the point of triage, to streamline emergency department workflows and to reduce reliance on X-ray referrals. Those goals depend on the injury detection module, which still needs its own clearance. The company says the regulatory approach and infrastructure built for BoneEnhance are meant to carry forward to that next submission.
