FDA-regulated AI-enabled medical devices with pediatric indications.

AI is increasingly used to support diagnosis and improve care efficiency. However, this retrospective descriptive cross-sectional study finds that only 4.4% of FDA-approved AI medical devices are labeled for pediatric use, with longer review time and limited clinical scope compared to adult devices. Pediatric tools are apt to focus on neurology diagnosis, while radiology and cardiology have fewer applications due to scarce high-quality imaging data caused by radiation concerns, posing ongoing challenges for pediatric-specific AI development.