US FDA Approval of Pediatric Artificial Intelligence and Machine Learning–Enabled Medical Devices
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.
Authors
- Ryan Brewster (ORCID: https://orcid.org/0000-0003-0051-2623)
- Florence T. Bourgeois (ORCID: https://orcid.org/0000-0001-7798-4560)
- Matthew Nagy (ORCID: https://orcid.org/0000-0001-5087-6674)
- Susmitha Wunnava (ORCID: https://orcid.org/0000-0001-8502-6047)
Institutions
- Boston Children's Hospital (US)
- Harvard University (US)
Publication Details
- Journal
- JAMA Pediatrics
- Published
- 2024-12-16
- DOI
- https://doi.org/10.1001/jamapediatrics.2024.5437
- Citations
- 19
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 21.45