FDA OKs MedCognetics’ QMTriage AI-Enabled Breast Cancer Screening Software

MedCognetics has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its QmTRIAGE artificial intelligence (AI)-enabled software for breast cancer screening.
 
The company’s AI technology is used to improve medical imaging efficiency and effectiveness to help 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,” Debasish Nag, CEO of MedCognetics told the press. “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 has a mission to combat AI bias and boost outcomes by widening the scope of the population it serves. The company collaborated with the UT Southwestern Medical Center, which has licensed MedCognetics IP, has equity in the company, and provided deidentified clinical data to assist in validating the firm’s AI algorithm.
 
The company also partnered with UT Dallas, which also has an equity stake by licensing IP. The MedCognetics platform also reduces the time a radiologist need to review a case according to the company, which is particularly crucial 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.