19 Dec 2022

MedCognetics Receives FDA 510(K) Clearance for Breast Cancer Screening Software

MedCognetics received FDA 510(k) clearance for its AI-powered breast cancer screening software QmTRIAGE, the company has announced.


As per the report, ‘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 de-identified 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.’


"MedCognetics is committed to leveraging our technology to help improve outcomes across a diverse group of patients and to do so, partnered with the both University of Texas at Dallas and the 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," Debasish Nag, CEO of MedCognetics, said in a statement.


UT Southwestern Medical Center and UT Dallas hold equity in the company. 



Join the HealthXL Webinar on ‘Retail Healthcare: Current and Future Opportunities for Digital Health’ on 26th January. Click here to Request to Join. 


Click here to read the original news story.


About Us

HLTH Inc. is a dynamic community delivering unique value to the healthcare industry through a mix of unparalleled global events, inspirational content, and impact-driven initiatives.

Hyve Logo

USA Event Dates

2026 | HLTH: Nov 15 – 18 | Las Vegas | Register | Sponsor
2027 | ViVE: Mar 14 – 17 | Nashville | Be First to Know | Sponsor
2027 | HLTH: Oct 17 - 20 | Las Vegas, NV

Europe Event Dates

2027 | HLTH Europe: June 21 - 24 | Amsterdam
2028 | HLTH Europe: June 19 - 22 | Amsterdam

Important Notice on Hotel Scams

Any communication that claims to represent HLTH or any third party offering discounted hotel rooms or attendee lists is NOT AFFILIATED with HLTH and should be considered fraudulent. Please book your accommodations only through HLTH’s official channels to ensure authenticity and security.