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First Digital Path AI Tool Cleared for Market by FDA

FDA’s action marks start of a new era in pathology where artificial intelligence helps with diagnosis

CEO SUMMARY: In a first for the anatomic pathology profession, the Food and Drug Administration (FDA) has cleared for market a digital pathology image analysis product intended to aid pathologists in the diagnosis of prostate cancer. Developed by New York City-based Paige, the Paige Prostate system was determined by the FDA to improve diagnostic accuracy …

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