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August 22, 2025JAMA Health ForumOpen Access

Early Recalls and Clinical Validation Gaps in Artificial Intelligence–Enabled Medical Devices

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Lack of clinical validation correlates with increased recalls of AI-enabled medical devices, and the impact is significant.
The study identifies a notable association, indicating that devices with poor validation are more likely to face recall actions.
Cross-sectional analysis of FDA-cleared AI-enabled medical devices reveals critical insights into their safety and effectiveness.
Findings highlight the need for improved clinical validation processes for AI-enabled medical devices to ensure patient safety.

Implication

Cross-sectional study finds links between recalls and clinical validation gaps in AI-enabled medical devices.

Abstract

This cross-sectional study examines whether lack of clinical validation and publicly traded manufacturer status were associated with recalls of artificial intelligence–enabled medical devices that had been cleared by the US Food and Drug Administration.

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Cite This Study

Lee et al. (2025) studied this question.

synapsesocial.com/papers/68af5407ad7bf08b1eadaf3d https://doi.org/10.1001/jamahealthforum.2025.3172

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Implication

Cross-sectional study finds links between recalls and clinical validation gaps in AI-enabled medical devices.

Early Recalls and Clinical Validation Gaps in Artificial Intelligence–Enabled Medical Devices

Key Points

Implication

Abstract

Discussion

Cite This Study

Early Recalls and Clinical Validation Gaps in Artificial Intelligence–Enabled Medical Devices

Key Points

Implication

Abstract

Discussion

Cite This Study

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