WASHINGTON, D.C. – The Food and Drug Administration (FDA) has issued a safety communication warning consumers about the false claims of wearable smart devices that allege to noninvasively measure blood glucose levels.
The FDA emphasized that it has not authorized, cleared, or approved any smartwatches or smart rings that claim to independently measure or estimate blood glucose values. Major wearable makers, including Apple Watch, Fitbit, Samsung, and Oura Ring, only support integrations with FDA-authorized continuous glucose monitors (CGM). These integrations allow users to monitor data from connected CGMs that have companion smartphone apps, such as the Dexcom G7.
The warning seems to be directed towards fraudulent devices making unverified claims, which are often found at trade shows like CES and sold through online marketplaces. The FDA urges consumers to report any companies selling these scammy devices through its MedWatch Voluntary Reporting Form.
It is important to be skeptical of any wearable device claiming to have FDA approval, as smartwatches and smart rings may have FDA-cleared features but are not considered medical devices and should not be treated as such.
Consumers, patients, and healthcare professionals are advised to exercise caution and consult with medical professionals before purchasing any wearable device that claims to measure blood glucose levels. The FDA’s warning serves as a reminder to beware of potentially misleading claims made by certain smart devices.