FDA medical device AI reports show major gaps in trustworthiness

A recent study analyzing FDA-cleared medical device reports from 2021-2025 revealed significant gaps in reporting on trustworthy AI principles. Researchers found that nearly a quarter of the analyzed reports provided no evidence for any of the six FUTURE-AI principles (Fairness, Universality, Traceability, Usability, Robustness, and Explainability), and none documented evidence for all six. Robustness was the most frequently reported principle, while Traceability and Explainability showed the most pronounced reporting deficiencies. The study concludes that regulatory approval alone is insufficient to guarantee the trustworthiness of AI in medical devices and calls for standardized, auditable reporting throughout the AI lifecycle. AI

IMPACT Highlights the need for standardized AI reporting in healthcare to ensure trust and responsible adoption of medical devices.

RANK_REASON Academic paper detailing research findings on AI reporting in medical devices. [lever_c_demoted from research: ic=1 ai=1.0]

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• AI/ML
• FDA

• paper
• policy
• safety

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