Therapixel garners FDA clearance for mammo AI software

French artificial intelligence (AI) software developer Therapixel has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its MammoScreen software for screening mammography exams.

MammoScreen automatically detects and characterizes suspicious soft-tissue lesions and calcifications on mammography exams, according to the vendor. It then provides a summary report that characterizes the likelihood of malignancy for each lesion with a score from 1 (least likely) to 10 (most likely).

The company said that a multireader, multicase study conducted last year showed that readers using MammoScreen detected more cancers on mammograms than radiologists who did not have access to the software.