FDA Clears RadNet's Updated AI Software for Prostate MRI

The Food and Drug Administration (FDA) has granted 510(k) clearance to Quantib Prostate 3.0 (RadNet), an artificial intelligence (AI)-based software that may bolster radiology workflow and interpretation of prostate magnetic resonance imaging (MRI).

Key features for Quantib Prostate 3.0, an update to Quantib Prostate 2.1 software, include an improved algorithm for prostate and subregion segmentation and automated lesion drawing on the PI-RADS sector map, according to RadNet.

The company adds that other benefits for enhancing the quality and speed of prostate MRI reporting include PSA (prostate-specific antigen) density calculation, one-click segmentation of lesion candidates, and precise registration and movement correction.

“The (clearance) of Quantib Prostate 3.0 represents another step forward in advancing prostate cancer care by bringing the latest in AI technology to MRI interpretation,” noted Gregory Sorenson, M.D., the president of RadNet’s AI Division. “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.”

(Editor’s note: For related content, see “Emerging Prostate and Brain MRI AI Platform Gets FDA Nod” and “Can Explainable AI Enhance Diagnosis and PI-RADS Classification of Prostate Cancer on MRI?”)