AI In Digital Pathology Market Regulatory Framework and Clinical...

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2026-06-30 11:32:41 -

AI In Digital Pathology Market Regulatory Framework and Clinical Validation

The regulatory landscape for AI in digital pathology has evolved significantly since the first FDA authorizations, transitioning toward comprehensive frameworks that govern pre-market review, post-market surveillance, and real-world performance monitoring. The U.S. Food and Drug Administration has established multiple pathways for AI pathology software, including the de novo classification...

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