Paige Prostate software receives FDA approval

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Sept. 23, 2021—The FDA authorized marketing of Paige‘s software Paige Prostate, a prostate cancer detection solution that identifies foci suspicious for cancer and provides the information to a pathologist. The software is the first AI-based pathology product to receive de novo approval from the FDA, allowing in vitro diagnostic use via the company’s FDA-cleared FullFocus digital pathology viewer.