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