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FDA clears AI-powered second-read tool that catches missed prostate cancers on biopsy

Later-Stage HumanFDA Approved

Cancer type: Prostate Cancer
Published: August 13, 2026

The FDA granted 510(k) clearance -- a real FDA regulatory action for a diagnostic device, distinct from the drug-approval pathway most other records on this site describe -- to Ibex…

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Last reviewed 2026-08-13