French artificial intelligence (AI) software developer Therapixel's MamoScreen software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with digital breast tomosynthesis.
The software was designed to help radiologists with breast screening by detecting and characterizing suspicious soft-tissue lesions and calcifications. The likelihood of malignancy of lesions is rated on a scale of 1-10.
MammoScreen was cleared for use with traditional 2D screening mammography in July, and the 3D tomosynthesis clearance will broaden its potential use to the whole U.S. mammography market, Therapixel said. The regulatory clearance was supported by a multireader study in which the software boosted performance while also saving reading time; a challenge with tomosynthesis is that the technology produces many images, according to the company.
![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)
