Therapixel has received the CE Mark for its MammoScreen software, which analyzes screening mammograms and indicates suspicious mammograms and lesions to radiologists.
The action means that MammoScreen can now be sold in the countries in the European Union, according to TheraPixel. The software received U.S. Food and Drug Administration clearance in March 2020.
After analyzing mammography images, MammoScreen generates a score that represents the probability of malignancy in a lesion and the algorithm's degree of confidence. The software has already been installed at 14 hospitals and radiology practices in France, where it is being evaluated clinically.