The U.S. Food and Drug Administration (FDA) has cleared AZmed's Rayvolve software for detecting fractures on x-rays.
A clinical study conducted at University Hospitals in Cleveland, OH, found that Rayvolve increased reader accuracy for identifying fractures on x-ray by 5.6%, improved sensitivity from 86% to 95%, boosted specificity from 82% to 83%, and decreased review and interpretation time by 27%, according to the firm.
The software received CE marking in 2021 and is being used in more than 300 healthcare facilities in 21 countries around the world, AZmed said.
![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)
