Objectives Prior publications have highlighted inconsistent labelling of intended use cases and target population for U.S. Food and Drug Administration-approved AI medical devices, especially for children. The extent to which this issue applies to devices within Europe remains unaddressed. Materials and methods A comprehensive review was conducted of all regulatory-approved AI medical devices for use in radiology from a non-profit, publicly available database. Two independent reviewers assessed information about all the devices regarding use case, modality and intended population. A third reviewer resolved any discrepancies. Where the intended population was unclear, a standardised review of the available evidence and marketing materials for the AI device was conducted. Results Only four (4/213, 2%) AI medical devices were clearly labelled for paediatric use. A further 11% were intended for all ages, including children. The majority (88/213; 41%) of all AI medical devices did not clearly demonstrate their intended population on the database. Further examination of the scientific literature and marketing of these “unclear” devices showed that 6 (6/88, 7%) of these included patients under 18 in their intended target population, but 47% (41/88) still remained unclear after further review. Conclusion Most regulated radiology AI medical devices have missing or unclear information regarding the appropriate use in children. This poses significant potential risk, including inadvertent off-label use, which could compromise patient safety. The EU AI Act emphasises the need for transparency and accountability in AI device deployment, and we therefore advocate for a standardised paediatric safety indicator to clearly communicate suitability. Key Points <Emphasis Type="BoldItalic">Question</Emphasis> To what extent do European-approved radiology AI devices provide clear labelling of intended use and suitability for paediatric populations? <Emphasis Type="BoldItalic">Findings</Emphasis> Many radiology AI medical devices in Europe lack explicit paediatric use information, raising concerns about unintended off-label use. <Emphasis Type="BoldItalic">Clinical relevance</Emphasis> Clear labelling of AI device suitability for children is essential to ensure safe use. A standardised safety indicator could aid clinicians in appropriate device selection. Graphical Abstract

Safe for kids? AI medical devices in radiology overlook paediatric suitability

期刊论文
发表日期：

2025年10月8日

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Brendan S. Kelly,
Jennifer Lee,
Edward Antram,
Owen Arthurs,
Susan C. Shelmerdine

摘要

Objectives

Prior publications have highlighted inconsistent labelling of intended use cases and target population for U.S. Food and Drug Administration-approved AI medical devices, especially for children. The extent to which this issue applies to devices within Europe remains unaddressed.

Materials and methods

A comprehensive review was conducted of all regulatory-approved AI medical devices for use in radiology from a non-profit, publicly available database. Two independent reviewers assessed information about all the devices regarding use case, modality and intended population. A third reviewer resolved any discrepancies. Where the intended population was unclear, a standardised review of the available evidence and marketing materials for the AI device was conducted.

Results

Only four (4/213, 2%) AI medical devices were clearly labelled for paediatric use. A further 11% were intended for all ages, including children. The majority (88/213; 41%) of all AI medical devices did not clearly demonstrate their intended population on the database. Further examination of the scientific literature and marketing of these “unclear” devices showed that 6 (6/88, 7%) of these included patients under 18 in their intended target population, but 47% (41/88) still remained unclear after further review.

Conclusion

Most regulated radiology AI medical devices have missing or unclear information regarding the appropriate use in children. This poses significant potential risk, including inadvertent off-label use, which could compromise patient safety. The EU AI Act emphasises the need for transparency and accountability in AI device deployment, and we therefore advocate for a standardised paediatric safety indicator to clearly communicate suitability.

Key Points

Question To what extent do European-approved radiology AI devices provide clear labelling of intended use and suitability for paediatric populations?

Findings Many radiology AI medical devices in Europe lack explicit paediatric use information, raising concerns about unintended off-label use.

Clinical relevance Clear labelling of AI device suitability for children is essential to ensure safe use. A standardised safety indicator could aid clinicians in appropriate device selection.

Graphical Abstract