FDA Warns Against Using Unauthorized Smartwatches and Rings for Blood Glucose Measurement FDA Warns Against Using Unauthorized Smartwatches and Rings for Blood Glucose Measurement

FDA Warns Against Using Unauthorized Smartwatches and Rings for Blood Glucose Measurement

The FDA has not authorized, cleared, or approved any smartwatch or smart ring

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The U.S. Food and Drug Administration (FDA) has issued a safety communication advising against the use of smartwatches or smart rings that claim to measure blood glucose levels without piercing the skin. This warning is directed at consumers, patients, caregivers, and healthcare providers, emphasizing that the FDA has not authorized, cleared, or approved any such devices for this purpose. The alert distinguishes these products from smartwatch applications that display data from FDA-authorized devices, such as continuous glucose monitoring devices (CGMs), which do require skin piercing. The...
Adapting FDA Regulation for AI and ML in Medical Devices Adapting FDA Regulation for AI and ML in Medical Devices

Adapting FDA Regulation for AI and ML in Medical Devices

A Proposed Framework for Safety and Innovation

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The FDA is exploring how to regulate medical devices that incorporate artificial intelligence (AI) and machine learning (ML), acknowledging that their traditional regulatory framework is not fully equipped for the adaptive nature of these technologies. Traditionally, the FDA regulates medical devices through pathways like premarket clearance (510(k)), De Novo classification, or premarket...
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