FDA Clears MammoScreen™ from Therapixel

Therapixel captured 510(k) clearance from the U.S. Food and Drug Administration this week for MammoScreen™, an explainable, actionable artificial intelligence (AI) tool designed to help with mammography interpretation.

The clearance comes after the release of findings from a multi-case study, company officials said, that showed radiologists had better cancer detection performance on mammograms when they used MammoScreen versus when they analyzed images solo.

“We believe MammoScreen will provide quick and reliable confirmation of radiologists’ suspicions as they read,” said Matthieu Leclerc-Chavlet, Therapixel chief executive officer. “This AI solution will ensure a more certain assessment by radiologists and a speedier reassurance of women having breast cancer screening exams, resulting in a more efficient workflow and reduced costs for the healthcare system.”

According to company information, MammoScreen can automatically detect and characterize suspicious soft tissue lesions and calcifications on mammography images while simultaneously assessing their likelihood of malignancy. Radiologists receive a summary report that categorizes each lesion’s suspiciousness on a scale of 1-to-10 with 10 being the most likely to indicate malignancy.