The US Food and Drug Administration (FDA) issued a cautionary advisory on Wednesday regarding the use of smartwatches and smart rings that purportedly measure blood glucose levels without the need for skin piercing. The FDA emphasized that it has not authorized or approved any such devices for standalone blood glucose measurement, warning of the potential dangers associated with their usage.
According to the FDA, reliance on these unauthorized devices can result in inaccurate blood glucose readings, also referred to as blood sugar levels, which may lead to critical errors in diabetes management with life-threatening consequences. These unapproved devices differ from smartwatch applications that merely display data from FDA-approved continuous glucose monitoring devices, which require skin penetration.
Risks of Inaccurate Blood Glucose Readings Highlighted by FDA
While the FDA refrained from naming specific brands, it underscored that sellers of these unauthorized smartwatches and smart rings promote them as utilizing “non-invasive techniques” for blood glucose measurement, eliminating the need for finger pricking or skin piercing. However, the agency clarified that these devices do not directly assess blood glucose levels, urging consumers to refrain from purchasing them for this purpose.
Furthermore, the FDA healthcare providers to engage in discussions with their patients regarding the risks associated with unauthorized blood glucose measuring devices. Providers were encouraged to assist patients in selecting appropriate, FDA-approved devices tailored to their specific needs. The FDA reiterated its commitment to preventing the illegal marketing of unauthorized smartwatches and smart rings claiming to measure blood glucose levels.
FDA Warn Blood Sugar Can’t Be Measured Without Needles: Smartwatches and Smart Rings Are All Scam | Wion
Consumers Advised to Avoid Unauthorized Devices for Diabetes Management
Consumers who experience adverse events or encounter issues with inaccurate blood glucose measurements from unauthorized smartwatches or smart rings were urged to report their concerns through the FDA MedWatch Voluntary Reporting Form. This reporting mechanism allows individuals to contribute to the ongoing monitoring and evaluation of medical device safety.
The FDA warning serves as a reminder of the importance of utilizing FDA-approved devices for blood glucose monitoring in the effective management of diabetes. As technology continues to evolve, ensuring the accuracy and safety of medical devices remains paramount in safeguarding the well-being of individuals managing chronic health conditions like diabetes.
The U.S. Food and Drug Administration issued a warning on Wednesday, cautioning against the use of smartwatches and rings that claim to measure blood sugar levels for medical purposes without the need for skin piercing. The FDA emphasized the potential dangers associated with these devices and advised consumers to steer clear of them.
The FDA warning applies to all smartwatches and rings, regardless of brand, that purport to measure blood glucose levels in a noninvasive manner, according to the agency. The FDA clarified that it has not granted authorization to any such device for medical use.
It’s important to note that the FDA warning notice does not pertain to smartwatch applications that are linked to sensors, such as continuous glucose monitoring systems, which directly measure blood sugar levels.
