Imaging giant RadNet earns FDA greenlight for AI-based prostate MRI software
Imaging industry giant RadNet recently scored FDA clearance for new AI-based software to aid with reading and reporting on prostate MRIs.
“Quantib Prostate 3.0” offers a suite of tools to help radiologists and urologists improve the quality of their assessments. They include artificial intelligence-powered volumetry, PSA (prostate-specific antigen) density calculations, and “precise” movement correction.
“The approval of Quantib Prostate 3.0 represents another step forward in advancing prostate cancer care by bringing the latest in AI technology to MRI interpretation,” Gregory Sorensen, MD, president of RadNet’s AI Division, said in a May 1 announcement. “With the increasing recognition of the important role MRI plays in prostate cancer diagnosis, we believe physicians will value the power that this software puts in their hands.”
Sorensen and colleagues said the latest 510(k) clearance introduces a “major upgrade” to the previous release. Other modifications include an improved prostate and subregion segmentation algorithm, automated drawing of lesions on the PI-RADS (Prostate Imaging Reporting & Data System) sector map and additional functionalities.
Rotterdam, Netherlands-based Quantib gained FDA clearance for the first-generation version of the product in 2021. RadNet later acquired the AI company in 2022 (alongside fellow Dutch vendor Aidence) for a total of nearly $100 million.
Publicly traded RadNet has increasingly moved into the AI space to diversify its offerings. But the burgeoning business line is still seeking profitability, as the Los Angeles-based imaging center operator reported $25 million in losses from its AI Division in 2022. However, company leaders have said they’re working to monetize the business and expect it to begin turning a profit in 2024. RadNet also recently announced that it will reveal its 2023 first quarter earnings results on Tuesday, May 9.
The company bills itself as the country’s leading operator of freestanding, fixed-site diagnostic imaging services, with 357 centers spanning California, Maryland, Delaware, New Jersey, New York, Florida and Arizona.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.