This recent JAMA Network Open opinion piece builds on new data about AI-enabled medical devices—and surfaces a deeper issue in pediatric care. While the underlying study found that only a small fraction of FDA-authorized AI devices have clear pediatric labeling (when applying a stricter, clinically meaningful definition), pediatric patients aren’t just underrepresented—they’re structurally disadvantaged in how AI tools are developed and approved. But the opinion goes further: • Many devices don’t specify patient age at all—leaving clinicians uncertain about appropriate use • Even when labeled for pediatric use, most lack clear evidence of pediatric validation • Labeling alone can create a false sense of safety if performance in children isn’t established The most important insight: transparency isn’t enough. Requiring clearer labeling without reducing development barriers could push manufacturers to simply exclude pediatric indications altogether. The path forward likely requires both: → better labeling standards → AND incentives + regulatory pathways that make pediatric innovation viable Thank you Kolaleh Eskandanian, R. Brandon Hunter, and Chester Koh for this enlightening perspective! #HealthPolicy #AIinHealthcare #Pediatrics #MedTech #Regulation
**Publication Alert** Our invited commentary, "Regulating AI in Pediatrics—Is Transparency Enough?" is out in JAMA Network Open. It was fun working on this piece with my colleagues R. Brandon Hunter, MD and Chester Koh, MD, MBA. Of 952 FDA-authorized AI-enabled medical devices approved over nearly three decades (1995–2024), only 4.4% included specific pediatric labeling, and most of those said nothing about intended patient age at all. Transparency mandates alone won't fix this; they must be paired with streamlined pathways and incentives that make pediatric #AI development worthwhile, not punitive. Our commentary was written in response to the original research article by first author, Greg Zapotoczny, senior author, Juan Espinoza, et al., "FDA-Regulated AI-Enabled Medical Devices With Pediatric Indications," published in JAMA Network Open Original Research: https://lnkd.in/emBjxR-J Commentary: https://lnkd.in/eba8xsmM DAIMLAS Artificial Intelligence Ecosystem Builders #AI #MedTech #Innovate4Kids #MedicalDevices #AICoLab