The U.S. Food and Drug Administration (FDA) has given 510(k) clearance to artificial intelligence (AI)-based breast and prostate cancer detection tools from RadNet's subsidiaries DeepHealth and Quantib.
DeepHealth's Saige-Dx is a more advanced successor to the company's Saige-Q worklist triage software. It uses AI to automatically identify suspicious lesions in mammograms and assigns a suspicion level to each finding and the entire case.
Quantib Prostate 2.0 is an AI-based software solution that advances an MRI prostate reporting workflow and offers a suite of tools, including AI-based segmentation and volumetry, precise registration and movement correction, one-click segmentation of lesion candidates, PI-RADS scoring support, and standardized reporting.
![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)
