U.S. FDA Clears MedCognetics’ AI Enabled Breast Cancer Screening Software

Digital Health Software Platform Reduces Time and Cost of Imaging and Improves Outcomes Across Diverse Patient Populations

DALLAS–(BUSINESS WIRE)–#AIMedCognetics, Inc. today announced it has received U.S Food and Drug Administration (FDA) 510(k) clearance of its artificial intelligence (AI)-enabled software for breast cancer screening, QmTRIAGE®. The Company is developing the next generation of AI medical imaging technology with an initial focus on improving outcomes of early breast cancer detection, particularly across a diverse group of patients, as well as helping radiologists with unmanageable caseloads. According to Margaretta Colangelo, an independent analyst focused on AI, there is a 10x demand for radiology services to the number of available radiologists worldwide; with 50 percent of those in practice experiencing depression or burnout. The Company’s AI technology is leveraged to improve the efficiency and effectiveness of medical imaging thus helping radiologists with unmanageable caseloads.

“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. “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 for us as we work toward expanding to other realms of cancer.”

MedCognetics is steadfast in its commitment to combating AI bias and improving patient outcomes by widening the depth and breadth of the population it serves. To address this lack of diverse populations, MedCognetics worked with the UT Southwestern Medical Center (UTSW) in Dallas, Texas. 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.

“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, and Chief of its Breast Imaging Division. “We are working to leverage this technology to address data bias regarding breast health and imaging.”


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.

Useful Links:

MedCognetics: www.medcognetics.com
FDA: www.fda.gov
Quality of Life Technology Laboratory at UT Dallas: https://ecs.utdallas.edu/research/researchlabs/QoLT/index.html
University of Texas Southwestern Medical Center: https://www.utsouthwestern.edu/

About MedCognetics, Inc.

MedCognetics provides an advanced AI software platform which integrates into radiology workflow. In addition, the AI algorithm is trained on a diverse global patient dataset to mitigate data biasing. The future of AI in healthcare is unbiased services and MedCognetics is at the forefront of creating a more predictable medical outcome and ultimately saving lives. Founded in 2019, the company is based in Dallas, Texas. For more information, please visit our website at www.medcognetics.com.


Alicia V. Nieva-Woodgate, ANW Networks, +1 720.808.0086, alicia@anwnetworks.com

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