Computer-aided detection (CAD) developer Parascript has received U.S. Food and Drug Administration (FDA) premarket approval (PMA) for version 6.1 of its AccuDetect software.
AccuDetect is indicated for use in screening mammography to identify areas suspicious for breast cancer for radiologist review after completing an initial read, according to the vendor. The software is approved for use with digital mammography systems manufactured by GE Healthcare and Philips Healthcare.
AccuDetect is currently being used commercially in Spain, France, Germany, and Austria, Parascript 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&fit=crop&h=112&q=70&w=112)





