FDA Clears RadNet's Updated AI Software for Prostate MRI

In a multinational, multicenter study of over 1,000 patients with recurrent prostate cancer, researchers developed and validated a nomogram that achieved a 72 percent concordance index for the prediction of biochemical recurrence after PSMA PET-guided salvage radiotherapy.

The use of adjunctive artificial intelligence (AI) reportedly improved lesion level sensitivity by nearly 19 percent and patient level specificity by 14 percent for the diagnosis of clinically significant prostate cancer on multiparametric magnetic resonance imaging (MRI).

The FDA granted 510(k) clearance to Unfold AI, which was formerly known as iQuest, in December 2022.

In addition to a previously FDA-cleared brain magnetic resonance imaging (MRI) module, the Advantis Platform features an artificial intelligence-powered prostate MRI module that offers simultaneous viewing of conventional and advanced sequences, and reportedly generates automated PI-RADS assessments.

In a study of over 1,200 men with over 3,200 prostatic lesions, an explainable artificial intelligence (AI) model demonstrated a sensitivity rate of 93 percent for detecting clinically significant prostate cancer.

A new study shows that active surveillance and watchful waiting are being utilized in nearly 60 percent of patients with low-risk prostate cancer in the United States.