“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,” the agency wrote in its update. “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.”
Providers should speak with their patients who require glucose monitoring and inform them about the way these devices are being marketed is misleading and direct them to use an FDA-approved glucose monitoring device.
The FDA says it recently learned of these devices claiming to monitor glucose levels with “non-invasive” methods and will be taking action to “ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels.”
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