Marketing and US Food and Drug Administration Clearance of Artificial Intelligence and Machine Learning Enabled Software in and as Medical Devices: A Systematic Review

IMPORTANCE: The marketing of health care devices enabled for use with artificial intelligence (AI) or machine learning (ML) is regulated in the US by the US Food and Drug Administration (FDA), which is responsible for approving and regulating medical devices. Currently, there are no uniform guidelin...

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Detalles Bibliográficos
Autores principales: Clark, Phoebe, Kim, Jayne, Aphinyanaphongs, Yindalon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2023
Materias:
Original Investigation
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10323702/
https://www.ncbi.nlm.nih.gov/pubmed/37405771
http://dx.doi.org/10.1001/jamanetworkopen.2023.21792

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