- FDA issued a safety communication warning consumers of risks related to smartwatches or smart rings that claim to measure blood glucose levels without piercing the skin.
- The warning states that FDA has not authorized, cleared, or approved any smartwatch or smart ring to measure or estimate blood glucose values on its own. This is different to smartwatch applications that display data from FDA-authorized blood glucose measuring devices that pierce the skin.
- While FDA enforcement levels for smart device medical applications have historically been relatively low, this safety communication indicates that FDA is paying attention – in this case, seemingly due to the risk posed to people with diabetes relying on inaccurate blood glucose measurements.
Reference:
https://www.fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication
