Pathologists and doctors have a new tool to help diagnose and confirm prostate cancer.

The Food and Drug Administration (FDA) on September 21, 2021, granted authorization to Paige, a digital diagnostics company, to market Paige Prostate—artificial intelligence software that can be used to diagnose prostate cancer. According to the FDA, the software is the first of its kind to use AI to help guide a clinician to detect the disease.

The purpose of the software application is to guide qualified pathologists in the diagnosis of prostate cancer, according to Carla Leibowitz, chief business development officer with New York–based Paige. The product analyzes digitized images of biopsies and identifies whether cancer is present—if cancer is found, the software guides the pathologist to where it has been detected.

As part of its authorization process, the FDA evaluated data from a clinical study that involved 16 pathologists who examined 527 digitized slides of