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Smart Watches to Measure Blood Glucose? “NO” FDA
(Thursday, February 29, 2024) There have been a few smartwatch apps and smart rings claiming to measure blood glucose levels without piercing the skin or sampling blood. These devices and apps are not regulated and hence can be sold directly to consumers without any independent validation and are popular because of their seeming ease of use. However, these devices are not accurate or authentic according to the FDA and should not be used. Smartwatches and other wearable devices come with several health-related apps that are not regulated as medical devices. These devices are considered “general health awareness” devices and are not considered regulated medical devices. The FDA is generally quite supportive of consumer benefits offered by such devices and apps. But that does not give developers the license to make false claims. The FDA made a public announcement this week about smartwatches or smart rings that claim to measure blood glucose levels or blood sugar without piercing the skin. FDA warned that these devices have not been independently validated, are not approved, and likely provide false and misleading information about user’s blood sugar levels. Inaccurate blood sugar readings can, in turn, hurt diabetes management for people with diabetes, and provide misleading information to all users, in general, trying to check their blood sugar levels. The announcement does not name any specific device, rather it warns against all wearable devices that claim to measure blood glucose levels without piercing skin. FDA also did not announce if it has initiated regulatory action against any such manufacturers. If you have developed a new kind of blood glucose monitor, you must discuss your device with the FDA and seek appropriate clearance or approval for your device. It is expected that the FDA may initiate regulatory action against manufacturers selling such wearable devices. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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