DeepHealth has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its DeepHealth Breast Ultrasound software.
The AI-powered application automates lesion detection, characterization, and reporting, according to the RadNet subsidiary, which reported greater than 98% accuracy in localizing breast lesions, an 8% improvement in sensitivity for breast cancer detection, and a 37% reduction in radiologist interpretation time.
DeepHealth Breast Ultrasound is now commercially available in the U.S. and is expected to be implemented across RadNet's network of imaging centers by the end of the year, the company 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)
