Medical Alert: FDA Issues Safety Communication Regarding Smartwatches and Smart Rings for Blood Glucose Monitoring
In a recent safety communication, the Food and Drug Administration (FDA) has issued a warning to the public, urging them to exercise caution when it comes to using smartwatches and smart rings to measure blood sugar levels without the need for skin pricks. The agency clarifies that no smartwatch or smart ring on the market currently has an FDA authorization or clearance to measure or estimate blood glucose values independently.
Limitations of Current Technology
For consumers seeking a non-invasive method for blood sugar monitoring, it is unfortunately not yet a feasible reality. Even popular wearables like the Apple Watch and Oura ring can only function as complementary devices, paired with FDA-approved wearable devices such as the Dexcom G7, which utilizes needles to attain accurate blood sugar readings. The development and availability of a smartwatch or smart ring capable of monitoring blood glucose levels without breaking the skin would represent a significant medical milestone, alleviating the daily burden of pricking for individuals with diabetes and providing vital notifications for pre-diabetics.
Apple and Samsung on the forefront
Industry giants Apple and Samsung have been investing considerable effort into exploring this breakthrough technology for several years. In 2020, Bloomberg reported that Apple had reached the “proof-of-concept stage” with its no-prick blood glucose monitoring solution, with the challenge remaining to reduce the form factor of the device. Apple’s active pursuit of this technology dates back to 2010; however, it may still take several more years before it can be integrated seamlessly into the Apple Watch. Samsung, not to be outdone, is also actively working on similar non-invasive monitoring capabilities, as evidenced by their recent announcement of the Galaxy Ring.
Caution in the meantime
Until these advancements become a reality, it is crucial to approach any claims made by devices currently available in the market with caution. The FDA emphasizes that existing smartwatches and smart rings do not have the capacity to directly measure blood glucose levels, regardless of any advertising claims. Consumers are urged to report any devices making such affirmations to the FDA via its MedWatch Voluntary Reporting Form, ensuring the agency remains informed about potentially misleading or harmful products.
While the future holds promise for revolutionizing blood glucose monitoring through smartwatches and smart rings, it is vital to stay informed, identify reputable devices, and act in line with the FDA’s recommendations for the sake of public health and safety.
