FDA-Regulated AI-Enabled Medical Devices With Pediatric Indications

What proportion of marketing applications for artificial intelligence (AI)–enabled medical devices reviewed by the US Food and Drug Administration (FDA) from 1995 to 2024 had pediatric indications?In this cross-sectional analysis of 952 regulatory submissions between 1995 and 2024, few devices were specifically labeled for children (ages 0-17 years); fewer still were exclusively pediatric, with the first one authorized for marketing in 2020. The top 3 pediatric clinical areas were radiology, neurology, and cardiology, with no pediatric-specific devices in most areas.These findings indicate that despite 30 years of AI devices on the market, pediatric-specific technologies emerged recently and remain scarce.

Corresponding Author: Juan Espinoza, MD, Stanley Manne Children’s Research Institute, Ann jespinozasalomon@luriechildrens.org).

Link to the article in your story

We encourage you to link out to this article in your story using the link below. It includes an access token that will give free access to the article for your readers up to one year after publication. (The link will be live after the article publishes and embargo is lifted.)

Please see the article for additional information, including full author list, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.

Need more information? Contact us.