Therapixel Gets FDA’s 510(k) Clearance for MammoScreen Cancer Screening Software

Paris, France-based Therapixel has received the FDA’s 510(k) clearance for its MammoScreen, expanding its approved use from 2D to 3D mammography — which is also called digital breast tomosynthesis.

The artificial intelligence-based software automatically detects and characterizes suspicious soft tissue lesions and calcifications in mammography and tomosynthesis images, and assesses how likely they are to be malignant.

Radiologists’ performance in screening for lesions improved when they used MammoScreen and they saved a significant amount of time, the company said.