Ensuring Adequate Development and Appropriate Use of Artificial Intelligence in Pediatric Medical Imaging.

Of over 100 FDA-cleared artificial intelligence (AI) tools for triage, detection, or diagnosis in medical imaging, only one is cleared for use in children. Thus, children may be unable to benefit from the advances that AI provides to adults. Furthermore, dataset demographics are frequently absent from the publicly available FDA documents, and it is not apparent that the software is unsuitable for use in pediatric patients. Herein, recommendations for change are proposed.