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

Nathan E Botts 0 369 Article rating: No rating

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 FDA's concern stems from the potential for inaccurate blood glucose measurements provided by these unauthorized devices, which could lead to serious errors in diabetes management. Such inaccuracies could result in taking incorrect doses of insulin or other medications, leading to dangerously low glucose levels, mental confusion, coma, or even death.

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