AI-Based Software Paige Prostate is Granted FDA Approval Through the De Novo Regulatory Pathway

September 27, 2021

Paige Prostate is the first artificial intelligence (AI)-based software designed to identify areas of concern (i.e., high likelihood of containing cancer) on a prostate biopsy image so they can be flagged for further review by a pathologist. The program is intended to be used as an adjunct tool to the review of digital scanner slide images from prostate biopsies.

The program was reviewed through the De Novo pathway, a regulatory pathway for low-to-moderate risk novel devices. The FDA authorization is based on clinical trial data which suggests improved detection of cancer on slide images by an average of 7.3% with Paige Prostate vs. unassisted examination by pathologists. The program also reduced the number of false-negatives by 70% and false-positives by 24%. This FDA authorization follows Paige AI receiving a CE mark for both its prostate software and its breast cancer product for use in the EU last year.

Paige’s co-founder and chief medical officer, David Klimstra, notes that Paige’s landmark FDA-approval and EU access “marks the beginning of a new era in the use of computer-assisted diagnostics for pathology.”

Written by Crystal Zhao and Kate Watkins