Devices like smartwatches and rings that promise to measure blood sugar levels for medical reasons without skin penetration may pose risks and are best to steer clear of, cautioned the US Food and Drug Administration on Wednesday.
According to the agency, it is important to be cautious with any watch or ring, regardless of brand, that claims to measure blood glucose levels in a non-invasive way. The FDA stated that no such device has been authorized, per The Independent.
FDA Acts on Unauthorized Blood Glucose Devices
The health regulator displayed its dedication to avoiding the illegal marketing of illegal gadgets that claim to measure blood sugar levels.
The Food and Drug Administration (FDA) has implemented measures to ensure that manufacturers, distributors, and sellers comply with regulatory guidelines in order to prevent the spread of potentially harmful devices in the market.
Distinguishing these devices from smartwatch applications authorized by the FDA to display data from blood glucose measuring devices that puncture the skin, the agency clarified that it has not granted approval for any smartwatch or smart ring capable of independently measuring or estimating blood glucose values.
Furthermore, the FDA has not evaluated the safety and effectiveness of such devices.
These unauthorized devices, manufactured by multiple companies and sold under different brand names, claim to be able to measure blood glucose levels without requiring skin puncture.
However, the FDA cautions that depending on incorrect blood glucose readings may result in significant mistakes in diabetes management.
This involves the risk of incorrect doses of insulin or other medications that can quickly lower sugar levels, leading to serious health dangers for users, according to Reuters.
Misleading Smartwatches for Blood Glucose Monitoring
It is crucial to differentiate these unauthorized devices from smartwatch applications that display data from FDA-approved continuous glucose monitoring devices, which involve skin puncture.
While the FDA did not specifically name the brands in question, it highlighted that sellers promoting these unauthorized smartwatches and smart rings often emphasize the use of "non-invasive techniques" to measure blood glucose levels without requiring skin puncture.
Despite these claims, the agency asserts that these devices do not directly test blood glucose levels and strongly urges consumers to refrain from purchasing them for that purpose.
In addition to cautioning consumers, the FDA advises healthcare providers to engage in discussions with patients regarding the risks associated with using unauthorized blood glucose measuring devices. The emphasis is on guiding patients to select appropriate and authorized devices tailored to their needs.
"The agency is working diligently to ensure that manufacturers, distributors, and sellers do not engage in the illegal marketing of unauthorized smartwatches or smart rings claiming to measure blood glucose levels," stated the FDA in its official communication.
The FDA urges consumers to report any adverse incidents linked to mistaken blood glucose readings caused by unauthorized smartwatches or smart rings in order to improve monitoring attempts.
Users can submit reports using the FDA MedWatch Voluntary Reporting Form, which aids in continuous monitoring and regulatory measures to protect public health, CNN News reported.
