MedCognetics’ AI enabled breast cancer screening software, QmTRIAGE, has received FDA 510(k) clearance. Photo credit: MedCognetics, Inc.
December 14, 2022 — Dallas, TX-based MedCognetics, Inc. announced it has received U.S Food and Drug Administration (FDA) 510(k) clearance for its AI enabled software for breast cancer screening, QmTRIAGE. The company provides an advanced AI software platform with the goal of reducing time and cost of imaging, and improving outcomes across diverse patient populations, according to a company statement. The platform integrates into radiology workflow and is also training its AI algorithm on a diverse global patient database to mitigate data biasing. MedCognetics has teamed up with the University of Texas at Dallas and University of Texas Southwestern Medical Center (UTSW) in Dallas, Texas to help achieve its goals.
“The American Cancer Society has stated that in 2022 approximately 287,850 new cases of invasive breast cancer will be diagnosed in women,” said Debasish Nag, chief executive officer, MedCognetics, Inc. “To do so, MedCognetics has partnered with both University of Texas at Dallas and University of Texas Southwestern Medical Center (UTSW) to address these disparities. In addition, 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 for us as we work toward expanding to other realms of cancer,” Nag added.
“The use of AI in medicine has helped bridge many gaps in the detection and treatment of cancers,” said W. Phil Evans, M.D., FACR, Clinical Professor of Radiology at UT Southwestern Medical Center (UTSW), and Chief of its Breast Imaging Division. “We are working to leverage this technology to address data bias regarding breast health and imaging,” noted Evans.
UTSW, which has licensed intellectual property to MedCognetics and holds equity in the company, provided the deidentified clinical data (i.e., breast imaging cases). These assisted in the validation of MedCognetics unbiased AI algorithm. The company also teamed up with UT Dallas, which also holds an equity stake, by licensing intellectual property from its Quality of Life Technology Laboratory. In addition to tackling the trend of training on a dominant ethnic population base, the MedCognetics platform also reduces the amount of time a Radiologist needs to review a case; this is especially vital in underserved communities and areas of the world where medicine and diagnostic imaging are scarce.
According to the statement released by MedCognetics on its FDA clearance, QmTRIAGE provides an unbiased advanced imaging algorithm that leverages AI and Machine Learning (ML) to detect the earliest manifestations of cancer in all ethnicities. The digital health software platform can be deployed on customer premises, via the cloud or through the web – providing customers with one of the most accessible medical AI algorithms on the market.
For information: www.medcognetics.com
March 26, 2026 
