Therapixel has received the CE Mark for its MammoScreen software, which analyzes screening mammograms and indicates suspicious mammograms and lesions to radiologists.
The action means that MammoScreen can now be sold in the countries in the European Union, according to TheraPixel. The software received U.S. Food and Drug Administration clearance in March 2020.
After analyzing mammography images, MammoScreen generates a score that represents the probability of malignancy in a lesion and the algorithm's degree of confidence. The software has already been installed at 14 hospitals and radiology practices in France, where it is being evaluated clinically.
![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.auntminnieeurope.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)
