Regulatory hurdles cleared by MedCognetics, Novartis
AI startup MedCognetics has been cleared to market software in the U.S. for detecting breast cancer on screening mammography.
The Dallas-based company says its newly FDA-approved product in this category, called QmTriage, incorporates bias-busting algorithmics that overcome the lack of diverse populations available for model training.
MedCognetics says it worked with UT Southwestern Medical Center to develop the software from deidentified patient data and is licensing intellectual property from the institution.
Further, UTSW holds equity in the company, as does UT Dallas.
“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,” the company says in a Dec. 14 announcement. “This is especially vital in underserved communities and areas of the world where medicine and diagnostic imaging are scarce.”
The announcement also quotes UT radiologist Phil Evans, MD.
“The use of AI in medicine has helped bridge many gaps in the detection and treatment of cancers,” Evans says. “We are working to leverage this technology to address data bias regarding breast health and imaging.”
In other news from the regulatory front, the Swiss-American pharma player Novartis has been cleared by the European Commission to sell a radioligand therapy for prostate cancer across the European Union.
The drug, called Pluvicto, is approved in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer, according to an announcement posted Dec. 13.
Novartis Europe president Haseeb Ahmad says the approval “marks a major milestone for patients with advanced prostate cancer who have few alternative treatments at this stage of their disease.”
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.