Regulators Compare US, Japan Approaches To Digital Health
Report Finds Most FDA-Approved AI Devices Are Used For Imaging
Medtech Connect Episode 4: Intelligent Devices
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In this episode of Medtech Connect, Medtech Insight regulatory reporter Hannah Daniel interviews, Kelliann Payne, partner at Hogan Lovells. Payne advises artificial intelligence (AI) medical device manufacturers with premarket submissions and helps them navigate the complicated regulatory landscape. She laid out the current FDA regulations for AI medical devices and explained the importance of predetermined change control plans, a new cyber regulation from the Consolidated Appropriations Act of 2023.
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In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to industry professionals at the Healthcare Information and Management Systems Society (HIMSS) 2024 conference about what they enjoy about the annual gathering and what excites them for the future.