The U.S. Food and Drug Administration (FDA) has cleared computer-aided detection (CAD) software developer iCAD's ProFound artificial intelligence (AI) version 3.0 for digital breast tomosynthesis (DBT).
The updated software improves specificity by 10%, sensitivity by 1%, and processing speed on its PowerLook platform by 40%, the company said.
In 2018, ProFound AI was the first 3D tomosynthesis software to be cleared by the FDA, according to iCAD. The new version was developed on more than 5 million images from 30,000 cases, including 8,000 biopsy-confirmed cancers; it was validated on 1 million images from 3,500 cases that included 1,200 biopsy-confirmed cancers, 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)
