Posted on Leave a comment

FDA Warns Against Using Smartwatches and Smart Rings for Blood Sugar Monitoring

In a recent announcement, the US Food and Drug Administration (FDA) has issued a cautionary alert regarding the use of smartwatches and smart rings for measuring blood glucose levels. The FDA highlighted significant risks associated with these devices, which claim to provide blood glucose readings without the need for skin piercing.

According to the FDA, none of these smartwatches or smart rings have received authorization or approval for standalone blood glucose level measurement. The agency emphasized that relying on such unauthorized devices could result in inaccurate readings, posing serious threats to diabetes management and potentially endangering lives. The FDA clarified that while certain smartwatch apps may display data from FDA-approved continuous glucose monitoring devices that do pierce the skin, the unauthorized devices in question employ non-invasive techniques that have not been validated for accurate blood glucose measurement.

Although the FDA did not specify particular brands, it warned consumers to be wary of products claiming to measure blood glucose levels without skin penetration. These devices, despite their claims, do not provide direct blood glucose testing and should not be utilized for such purposes, the FDA stressed. Healthcare providers were also urged to engage in discussions with patients regarding the risks associated with unauthorized blood glucose measuring devices and to aid them in selecting appropriate FDA-authorized alternatives for their medical needs.

Furthermore, the FDA reiterated its commitment to preventing the illegal marketing of unauthorized smartwatches and smart rings for blood glucose monitoring. Consumers encountering adverse events or encountering inaccurate blood glucose measurements from using these unauthorized devices are encouraged to report such incidents through the FDA MedWatch Voluntary Reporting Form.

In light of these warnings, individuals dependent on accurate blood glucose measurements for medical management are advised to consult with their healthcare providers to ensure the use of FDA-approved devices for monitoring their condition effectively and safely.

Leave a Reply

Your email address will not be published. Required fields are marked *