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Medical Devices / Submissions and Approvals

FDA Hands Paige.Ai Breakthrough Designation for Cancer Diagnosis Tool

March 12, 2019
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The FDA awarded Paige.Ai breakthrough device designation for an artificial intelligence system designed to diagnose cancer.

The diagnostic tool reviews digitized slides through an arrangement with a cancer center and funding is available for digitization of four million slides.

The software uses an algorithm that is trained with expert cancer diagnoses and is the first publicly announced AI tool for diagnosing cancer.

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