FDA warns against smartwatches, rings claiming blood glucose measurement capability
The Food and Drug Administration (FDA) has issued a safety warning to patients, consumers, and healthcare professionals in the US. It states that no smartwatch or smart ring has been authorized, cleared, or approved for measuring or estimating blood glucose values on its own. This warning comes as wearable technology claiming noninvasive blood glucose measurement capabilities gains more attention. The FDA has urged to be cautious of such claims and report any suspicious devices through its MedWatch Voluntary Reporting Form.
No major wearable capable of blood glucose measurement
Currently, no major wearable maker, such as Fitbit, Apple Watch, Samsung watch, or Oura Ring, has a device capable of measuring blood glucose levels. These wearables can only support integration with FDA-authorized continuous glucose monitors (CGMs), which use needles to measure blood sugar levels. Users can monitor data received from connected CGMs through companion smartphone apps like the Dexcom G7. However, no smartwatch or smart ring has received FDA authorization for blood glucose measurement.
Scammy devices making unsubstantiated claims targeted by FDA
The FDA's warning mainly targets dishonest companies selling smartwatches and rings claiming noninvasive blood glucose measurement capabilities. These devices are often found at trade shows such as CES and sold directly on company websites, via crowdfunded campaigns, or online marketplaces like Alibaba. Consumers should be skeptical of any wearable that claims to have FDA approval for blood glucose measurement and report such devices to the FDA.
Promising progress in wearable space
Although Apple and Samsung have teams working on blood glucose monitoring technology, no device has been authorized by the FDA for this purpose. Misleading headlines may suggest that reputable wearable companies can already measure blood glucose, but this is not the case. While there has been certain progress in the wearable space, experts believe that we are still many years away from devices that would be ready for healthcare settings, let alone consumer use.
