Therapixel has received two 510(k) clearances from the U.S. Food and Drug Administration (FDA).
One is for the update of Therapixel's MammoScreen AI software. The other supports the product's breast density assessment feature. The clearances result in the release of MammoScreen as a comprehensive suite, assisting radiologists in the breast cancer screening workflow, according to Therapixel.
MammoScreen features a case precheck to help eliminate searching for documents, prereporting feature that allows radiologists to submit reports more quickly, and recognition of prior mammograms in the evaluation of screenings. The product is intended for use as a concurrent reading aid to help identify findings on screening full-field digital mammography and digital breast tomosynthesis.
