FDA authorizes AI-based software for prostate cancer detection

The FDA has authorized the marketing of Paige Prostate, an AI-based software platform to help pathologists identify prostate cancer when they review slide images from prostate biopsies.1 The standard biopsy review process involves the pathologist examining digitally scanned slide images from prostate biopsies to find areas that are suspicious for cancer. Paige Prostate provides a supplementary assessment of the image and locates the area with the highest probability of harboring cancer. The pathologist can then examine this specific area further if they did not identify it on their initial assessment. "Pathologists examine biopsies of tissue suspected for diseases, such as prostate cancer, every day. Identifying areas of concern on the biopsy image can help pathologists make a diagnosis that informs the appropriate treatment," Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, stated in a press release.