Paris-based Therapixel scores FDA clearance for breast image reading assistant

Therapixel has gained U.S. Food and Drug Administration clearance for an AI-based software that can help radiologists read breast images.

MammoScreen, as it’s called, operates by automatically detecting and characterizing suspicious soft tissue lesions and calcifications, the Paris-based company said Thursday. The company submitted the application following a multi-reader study conducted in 2019.

Founder and Chief Scientific Officer Pierre Fillard called the news a “major milestone” for Therapixel, and the result of collaboration with radiologists over the last three years. The France firm said that partnership paid off with its team winning the DREAM Challenge back in 2017.

"We believe MammoScreen will provide quick and reliable confirmation of radiologists' suspicions as they read," Therapixel CEO Matthieu Leclerc-Chalvet said in a statement.