Press Release

September 22, 2021
1 min read

FDA grants marketing authorization for software to detect prostate cancer


Press Release

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The FDA authorized marketing of software designed to help pathologists detect prostate cancer.

Paige Prostate (Paige.AI) is intended to be used in conjunction with reviews of digitally scanned slide images from prostate biopsies.

Source: Adobe Stock.

Paige Prostate is the first artificial intelligence-based software designed to identify areas on the prostate biopsy with the greatest likelihood of containing cancer.

“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, said in an agency-issued press release. “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.”

Paige Prostate is compatible with digitized slide images.

The FDA evaluated data from a study in which 16 pathologists examined 527 slide images of prostate biopsies digitized with a scanner. The images included 171 cancerous and 356 benign samples.

Pathologists completed two assessments for each slide — one with assistance of Paige Prostate and one without.

Results showed Paige Prostate improved detection of cancer on individual slide images by 7.3%, with no impact on readings of benign slide images.