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@jhalamka 2 years ago
Software as a medical device (#SaMD) continues to evolve with advances in #machinelearning. So do the federal regulations governing these digital tools. @plcerrato and I explain in our latest blog: https://www.mayoclinicplatform.org/2022/06/13/keeping-up-to-date-on-samd-regulations/
@_bakulpatel 5 years ago
Excited about today’s announcement: FDA’s Digital Health team released a discussion paper with steps to consider a tailored framework for regulating #AI / #MachineLearning medical device software #samd #digitalhealth https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/SoftwareasaMedicalDevice/UCM635052.pdf https://t.co/UZ4VyYLtk4
@techcrunch.com 6 years ago
Cognoa’s AI platform for autism diagnosis gets first FDA stamp