The U.S. Food and Drug Administration has awarded de nova authorization to what it says is the first AI-based software designed to spot areas of interest on prostate biopsy images.

Developed by Paige.AI, the Paige Prostate tool highlights areas with the highest likelihood of containing cancer for pathologists to further scrutinize. The tool is best used as an assistant to avoid false negative and false positive results, the FDA said on Tuesday.

The administration believes the software can enhance diagnostic decision-making and inform appropriate treatment.

“Pathologists examine biopsies of tissue suspected for diseases, such as prostate cancer, every day,” said 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. “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.”

The FDA said it reviewed clinical study data from 16 pathologists who analyzed more than 500 prostate biopsy slides. For each image, providers read samples with Paige Prostate and without it. Assisted interpretations improved cancer detection by 7.3%, on average, and had no impact on assessing benign slides.

FDA’s de novo review is reserved for new, low-to moderate-risk devices. And with this authorization, devices of the same type and intended use can gain marketing authorization via the administration’s 510 (k) premarket process.