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.
