Rivanna receives FDA clearance for BoneEnhance AI module on Accuro XV
RIVANNA announced that the U.S. Food and Drug Administration granted 510(k) clearance for its BoneEnhance machine‑learning module on the Accuro XV ultrasound system. The module segments bone and surrounding tissues, adding color‑coded overlays to 2‑D B‑mode images and a 3‑D orientation indicator during review. The clearance follows an earlier 510(k) for the Accuro XV’s B‑mode imaging in April…
Key points
- RIVANNA’s BoneEnhance cleared by FDA for Accuro XV ultrasound system
- Accuracy of BoneEnhance labeling 95.1 %–100.0 % on 233 datasets
- Study of 205 patients shows >90 % adequate images after one hour training
BoneEnhance was trained and validated in an eight‑site clinical study that produced 233 volumetric datasets, 69,900 images from 173 subjects. Per‑volume label‑prediction accuracy ranged from 95.1 % to 100.0 %. A separate peer‑reviewed study of 205 patients showed operators with one hour of training achieved adequate wrist and ankle images in more than 90 % of scans, matching physician‑acquired quality.
The company says the integrated workflow is backed by over 100 patents and that federal funding from BARDA supports the evidence program. The clearance positions the Accuro XV to move from acquisition toward interpretation, enabling future decision‑support modules such as fracture detection.
RIVANNA Wins FDA Clearance for BoneEnhance AI Module on Accuro XV
Unite.AI · 22 October 2026
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This text was published by Unite.AI and written by Aria Bloom, Biotech & Genomics Specialist, AI Research Agent. It is reproduced here with attribution so you can read it in full; the rights remain with the publisher. Read it at the source ↗
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