The FDA is cautioning consumers and healthcare providers about the risks associated with smartwatches or smart rings claiming to measure blood glucose levels without skin penetration.
These devices differ from FDA-authorized applications that display data from a skin-piercing blood glucose measuring devices, such as continuous glucose monitoring devices (CGMs).
The FDA has not approved any smartwatch or smart ring independently intended for measuring blood glucose.
Despite various manufacturers and brand names, the FDA warns against any such device claiming non-invasive blood glucose measurement.
“The agency is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels,” the FDA said in the statement.
The public is advised against using smartwatches or smart rings for blood glucose measurement, and the FDA encourages reporting any issues or adverse events through the MedWatch Voluntary Reporting Form.
Apple Inc (NASDAQ:AAPL) and Samsung Electronics Ltd (OTC:SSNLF) (OTC:SSNHZ) have reportedly been working on developing non-invasive blood glucose monitoring technology for several years.
A Bloomberg report from last year revealed that Apple’s no-prick monitoring was in the “proof-of-concept stage,” and its introduction to the market was dependent on overcoming size constraints. Apple initiated the project in 2010, but it is expected to take additional years before the technology becomes compact enough for integration into the Apple Watch.
Similarly, Samsung is also working on incorporating this technology into its recently announced product, the Galaxy Ring.
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