Author

R. Singh

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Review Jul 2026

Regulatory Approval Is Not Enough: Gaps in Trustworthy AI Reporting in FDA-Cleared Medical Devices

Substantial, persistent trustworthy AI reporting gaps exist in FDA documentation, and standardised, audit-ready reporting across the AI lifecycle is needed to support independent assessment and responsible adoption of healthcare AI.

Ahmed M. A. Salih, Oliver Díaz, Alejandro Guzmán et al. · 0 citations