European radiology
Safe for kids? AI medical devices in radiology overlook paediatric suitability.
Brendan S Kelly, Jennifer Lee, Edward Antram, Owen Arthurs, Susan C Shelmerdine
Published: 202510.1007/s00330-025-11975-6
Abstract
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 d…
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