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US FDA Approval of Pediatric Artificial Intelligence and Machine Learning–Enabled Medical Devices

Year: 2024

Type: article

Abstract: This cross-sectional study analyzes the availability of artificial intelligence and machine learning–enabled devices authorized for children by the US Food and Drug Administration (FDA) and assesses reporting of algorithm validation in the pediatric population.

Source: Archives of Pediatrics and Adolescent Medicine

DOI: 10.1001/jamapediatrics.2024.5437

Authors: Ryan C. L. Brewster, Matthew Nagy, Susmitha Wunnava, Florence T. Bourgeois

Institutions: Boston Children's Hospital, Harvard University, Harvard-MIT Center for Regulatory Science

Language: English

Topic: Artificial Intelligence in Healthcare and Education

Subfield: Health Informatics

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: hybrid

OpenAlex ID: W4405425835