Paige Prostate AI Software Marketing Authorization

FDA has authorized the de novo marketing of Paige AI’s Paige Prostate software that is intended to assist pathologists in detecting areas that are suspicious for cancer as an adjunct to reviewing digitally-scanned slide images from prostate biopsies. The artificial intelligence (AI)-based software is designed to identify suspect areas on prostate biopsy images if the area of concern has not been identified on initial review, according to an agency release.

De novo authorization is based on data from a clinical study where 16 pathologists examined 527 slide images of prostate biopsies (171 cancer and 356 benign) that were digitized using a scanner. The study found that AI software improved cancer detection on individual slide images by 7.3% on average when compared to pathologists’ unassisted reads for whole slide images of individual biopsies, FDA says.