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Today, the U.S. Food and Drug Administration (FDA) issued a safety communication warning consumers, patients, caregivers, and health care providers of risks related to using smartwatches or smart rings that claim to measure blood glucose levels (blood sugar) without piercing the skin. These devices are different than smartwatch applications that display data from FDA-authorized blood glucose measuring devices that pierce the skin, like continuous glucose monitoring devices (CGMs). The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own.
This safety communication provides:
- A description of the unauthorized smartwatches and smart rings.
- Information about the risks associated with using the devices.
- Important recommendations for people who measure their glucose and their caregivers.
- Recommendations for health care providers.
- Actions the FDA is taking to address the issue.
- Instructions for reporting problems with smartwatches and smart rings that claim to measure blood glucose to the FDA.
Questions?
If you have questions about this safety communication, contact the Division of Industry and Consumer Education.
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