FDA Approves Paige Prostate Software for Cancer Detection

The FDA has granted a marketing authorization to New York-based Paige.AI for its Paige Prostate, the first artificial intelligence (AI)-based software designed to assist pathologists in detecting prostate cancer.

Paige Prostate can be used to identify potential problem areas in images that have been digitized using a scanner, and the results can then be visualized using a slide image viewer.

“The authorization of this AI-based software can help increase the number of identified prostate biopsy samples with cancerous tissue, which can ultimately save lives,” said Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health.