{"version":1,"type":"story","url":"https://digestai.news/story/rivanna-receives-fda-clearance-for-boneenhance-ai-module-on-accuro-xv","json":"https://digestai.news/story/rivanna-receives-fda-clearance-for-boneenhance-ai-module-on-accuro-xv.json","markdown":"https://digestai.news/story/rivanna-receives-fda-clearance-for-boneenhance-ai-module-on-accuro-xv.md","slug":"rivanna-receives-fda-clearance-for-boneenhance-ai-module-on-accuro-xv","headline":"Rivanna receives FDA clearance for BoneEnhance AI module on Accuro XV","summary":"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 2026 and a May 7, 2026 announcement of commercial use for musculoskeletal imaging.\n\nBoneEnhance 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.\n\nThe 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.","keyPoints":["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"],"whyItMatters":"FDA clearance validates AI‑assisted bone imaging, expanding clinical use of ultrasound and paving the way for future AI decision‑support tools in musculoskeletal care.","category":{"slug":"enterprise","name":"Enterprise & Industry","url":"https://digestai.news/category/enterprise"},"entities":{"companies":["RIVANNA"],"models":["BoneEnhance"],"people":["Will Mauldin","Delphine Le Roux"]},"firstPublishedAt":"2026-10-22T18:26:02Z","updatedAt":"2026-10-22T18:26:02Z","sourceCount":1,"hasPrimarySource":false,"sources":[{"outlet":"Unite.AI","title":"RIVANNA Wins FDA Clearance for BoneEnhance AI Module on Accuro XV","url":"https://unite.ai/rivanna-wins-fda-clearance-for-boneenhance-ai-module-on-accuro-xv","publishedAt":"2026-10-22T18:26:02Z","type":"press","primary":false,"lead":true}],"sourceNotes":null,"discussions":[],"thread":null,"cite":{"text":"Digest AI, \"Rivanna receives FDA clearance for BoneEnhance AI module on Accuro XV\", 22 October 2026, https://digestai.news/story/rivanna-receives-fda-clearance-for-boneenhance-ai-module-on-accuro-xv","publisher":"Digest AI","title":"Rivanna receives FDA clearance for BoneEnhance AI module on Accuro XV","datePublished":"2026-10-22T18:26:02Z","url":"https://digestai.news/story/rivanna-receives-fda-clearance-for-boneenhance-ai-module-on-accuro-xv"},"generatedBy":"Written by Digest AI's editorial model from the linked sources; the sources are the record.","license":"Headlines, digests and key points are written by Digest AI and may be quoted with a link to the story page. Linked articles belong to their publishers. Terms: https://digestai.news/terms#reuse"}