FDA-Regulated AI-Enabled Medical Devices With Pediatric Indications.

Abstract

Artificial intelligence (AI)-based technologies hold promise for faster and more accurate devices in health care; however, little is known about their availability to pediatric patients. A comprehensive analysis of US Food and Drug Administration (FDA) regulatory submissions is necessary to identify technologies with pediatric labeling. To characterize AI devices marketed in the US, identify those with pediatric indications, and provide clues on AI-specific barriers to pediatric device innovatio