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Yaeger, K.A., Martini, M., Yaniv, G., Oermann, E.K. and Costa, A.B. (2019) United States Regulatory Approval of Medical Devices and Software Applications Enhanced by Artificial Intelligence. Health Policy and Technology, 8, 192-197.
https://scholars.mssm.edu/en/publications/united-states-regulatory-approval-of-medical-devices-and-software-2

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