Dallas MedCognetics Gets FDA Clearance for Its AI-Enabled Breast Cancer Screening Software » Dallas Innova

Can artificial intelligence help detect breast cancers early, improving outcomes for a diverse group of patients? That’s the goal of an advanced artificial intelligence software platform from Dallas-based MedCognetics, which last week received key clearance from the US Food and Drug Administration.

The software platform, branded QmTRIAGE, integrates into the radiology workflow and has a high detection accuracy rate, according to Debasish Nag, CEO of MedCognetics. The early-stage startup, which was founded in 2019, aims to develop the next generation of AI medical imaging technology to find cancerous tumors less than 2 centimeters in size.

The platform’s “unbiased” advanced imaging algorithm leverages artificial intelligence and machine learning “to detect early manifestations of cancer in all ethnicities,” the company says.

“The American Cancer Society has stated that approximately 287,850 new cases of invasive breast cancer will be diagnosed in women by 2022,” Nag said in a statement. “The FDA [510(k)] the removal is a very important first step for us as we work to expand into other cancer arenas.”

Aiming to address the global shortage of radiologists, while reducing ‘burnout’

demeaning nag

QmTRIAGE is also intended to help radiologists struggling with unmanageable caseloads, the company said. According to Margaretta Colangelo, an independent AI-focused analyst, there is currently a “ten times greater” global demand for radiology services compared to the number of radiologists available, and 50% of practicing radiologists experience depression or burnout.

MedCognetics’ artificial intelligence technology aims to help overstretched radiologists by providing both the “scale and throughput” to address the gap, while improving the efficiency and effectiveness of medical imaging. “The high detection accuracy of our software allows for reduced review time by radiologists, another key component in improving outcomes,” Nag said.

Worked with UT Dallas and UT Southwestern to improve outcomes for ‘all ethnicities’

Laxman Tamil

Nag says his company was very focused on improving results for a diverse society. youToday’s artificial intelligence systems train on small, non-diverse data sets and do not represent all races and ethnicities of patients, his company notes.

“MedCognetics is committed to leveraging our technology to help improve outcomes in a diverse group of patients, and to do so, we partnered with the University of Texas at Dallas and the University of Texas Southwestern Medical Center to address these disparities.” Nag said.

Lakshman Tamil, Ph.D., a professor at UT Dallas, is a co-founder of MedCognetics.

The company’s core team also includes Chief Medical Officer Vasant Garg, MD; Tim Cogan, Ph.D., director of AI/ML; Quality Manager John Jenkins; Clinical Development Officer Paula Gupta, MD; and Chris Beaty, Vice President of Operations.

Received $750K from the NIH for an unbiased AI study

The company, which received $750,000 from the National Institutes of Health for its impartial AI study, says it takes advantage of “nine independent data sources around the world” to help you ensure data diversity.

Basak Dogan, MD, of UT Southwestern, is working with the company to help train its system.

“At UTSW we are working to integrate existing and ongoing AI algorithms into the early stages of the disease, which is key to saving lives,” Dogan said in a statement. “We worked with MedCognetics to help train their system to detect early-stage breast cancers, which is important to help use AI for breast cancer detection as a stand-alone tool. We are pleased to partner with MedCognetics in our mission to help maximize lives saved from breast cancer.”

MedCognetics added that its initial patent is pending for the software platform and two additional related patents are pending.

Growing use of AI in breast imaging and concern over racial disparities

The use of AI in breast imaging has grown rapidly and currently accounts for 15% of the total AI imaging market, according to MedCognetics.

The challenge: Studies have shown that the use of artificial intelligence can lead to “data bias” affecting people of color. A STAT Investigation—a health and medical-focused news service produced by Boston Globe Media—explored whether AI tools for breast cancer worsen disparities. STAT said “inconsistent public data in FDA submissions” have fueled concern. The research noted that when the FDA grants approvals to AI products without requiring them to publicly disclose how extensively their tools have been tested in people of color, it “threatens to worsen already vast disparities in breast cancer outcomes, a disease that is 46% more likely to be fatal for black women.”

MedCognetics’ partnership with UT Dallas and UT Southwestern to address the issue reflects the importance the company believes the issue is. So much so that the company reproduces the above STAT quote on your own website.

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