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Development and Commercialization Pathways of AI Medical Devices in the United States: Implications for Safety and Regulatory Oversight

Branden Lee, Shivam Patel, Crystal Favorito, Sara Sandri, Maria Rain Jennings, Tinglong Dai

2025NEJM AI12 citationsDOI

Topics & Concepts

CommercializationBusinessRegulatory scienceRisk analysis (engineering)Engineering ethicsEngineeringMedicineMarketingPathologyArtificial Intelligence in Healthcare and EducationBiomedical and Engineering EducationQuality and Safety in Healthcare
Development and Commercialization Pathways of AI Medical Devices in the United States: Implications for Safety and Regulatory Oversight | Litcius