The Centers for Medicare & Medicaid Services (CMS) has issued a new Request for Information (RFI) aimed at transforming how digital health tools serve Medicare beneficiaries....more
5/22/2025
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The U.S. Food and Drug Administration will focus on “Total Product Lifecycle Considerations for Generative AI-Enabled Devices” during its upcoming Digital Health Advisory Committee meeting on November 20–21. This meeting will...more
regulators. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD). Several years ago, the FDA upgraded its...more