The FDA issued a warning cautioning both healthcare providers and patients against the use of smart devices such as watches and rings that claim to measure glucose levels without skin piercing. The agency clarified that these devices are distinct from smartwatch applications that display data from FDA-authorised blood glucose measuring devices, specifically those that involve skin piercing, like continuous glucose monitoring devices.
In their update, the FDA emphasised that they have not granted authorisation, clearance, or approval for any smartwatch or smart ring intended to independently measure or estimate blood glucose values. They highlighted the misleading marketing tactics employed by these devices, particularly those claiming to provide "non-invasive" methods of monitoring glucose levels.
Healthcare providers were urged to communicate with their patients who require glucose monitoring, informing them about the deceptive marketing practices associated with these devices. The FDA recommended guiding patients towards the use of FDA-approved glucose monitoring devices, emphasising the importance of reliable and authorised technology in managing health conditions.
The FDA disclosed that they recently became aware of devices falsely claiming to monitor glucose levels through "non-invasive" means. The agency asserted its commitment to taking action to prevent the illegal marketing of unauthorised smartwatches or smart rings that make false claims regarding their ability to measure blood glucose levels. This proactive approach aims to safeguard both healthcare providers and patients from potential risks associated with the use of unapproved and misleading devices in the management of health-related data.
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