The U.S. Food and Drug Administration (FDA) has cleared Gleamer's BoneView artificial intelligence (AI)-based software, which detects bone fractures on x-rays.
BoneView detects fractures in x-rays and presents them to radiologists for final validation. The software's algorithm is cleared as a computer-assisted detection and diagnosis (CADe/CADx) application and highlights regions of interest with bounding boxes around areas where fractures are suspected so radiologists can prioritize reading those x-rays.
The software is currently available in the U.S. through Gleamer, Fujifilm Medical Systems, Aidoc, Ferrum Health, and Blackford Analysis. BoneView is already being used in 13 countries in Europe, Asia-Pacific, and North America.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
