Texas-based MedCognetics received FDA 510(k) clearance for its AI-powered breast cancer screening software QmTRIAGE.
QmTRIAGE uses AI to analyze 2D full-field digital mammography screenings and flags those suggestive of abnormalities for radiologists’ review.
MedCognetics’ software uses datasets gathered from deidentified clinical data from UT Southwestern Medical Center in Dallas and intellectual property from UT Dallas’ Quality of Life Technology Laboratory to improve early breast cancer detection.
UT Southwestern Medical Center and UT Dallas hold equity in the company.
“MedCognetics is committed to leveraging our technology to help improve outcomes across a diverse group of patients and to do so, partnered with both University of Texas at Dallas and University of Texas Southwestern Medical Center (UTSW) to address these disparities. In addition to this, our software’s high detection accuracy enables reduced time for review by radiologists, another key component to improved outcomes. The FDA’s clearance is a very important first step