The US Food and Drug Administration (FDA) has warned the public against using smartwatches or smart rings that claim to measure blood sugar levels without piercing the skin.
"The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own," the agency said in a news release.
FDA Warns About Using Smartwatches and Smart Rings
The agency noted that no such devices have been authorized, cleared, or approved by the FDA. These wearable devices differ from those that display data from FDA-authorized blood glucose measuring devices, such as continuous glucose monitoring devices (CGMs) requiring skin penetration.
The FDA underscored the potential risks associated with inaccurate blood glucose measurements, particularly for individuals managing diabetes.
The agency said incorrect readings could lead to errors in medication dosages, posing serious health risks, including dangerously low blood glucose levels that could result in coma or death.
Consumers, patients, caregivers, and healthcare providers are urged to refrain from purchasing or using smartwatches or smart rings claiming to measure blood glucose levels without skin penetration.
These devices, often marketed online or directly by sellers, lack FDA review and approval, raising concerns about the accuracy of their measurements.
Healthcare providers are encouraged to discuss the risks associated with unauthorized blood glucose measuring devices with their patients and recommend suitable FDA-authorized alternatives when necessary.
The FDA highlighted that sellers of these devices often claim to use non-invasive techniques to measure blood glucose levels but do not directly test blood glucose.
Numerous companies manufacture these smartwatches and smart rings under various brand names. The FDA's notice applies to all devices that measure blood glucose without piercing the skin, irrespective of the manufacturer or brand.
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FDA Seeks to Prevent the Illegal Marketing of Smartwatches
The FDA is monitoring the medical device market for unauthorized products and is working to prevent the illegal marketing of smartwatches and smart rings claiming to measure blood glucose levels.
The agency aims to raise awareness among consumers about the limitations of these devices and emphasizes that they should not be relied upon for blood glucose measurement.
Furthermore, the FDA encouraged individuals who believe they have experienced inaccurate blood glucose measurements or adverse events from using unauthorized smartwatches or smart rings to report their concerns through the MedWatch Voluntary Reporting Form.
Prompt reporting of problems can assist the FDA in enhancing patient safety by identifying and understanding the risks associated with these medical devices.
The FDA's notice alerts the public about the risks associated with using smartwatches and smart rings for blood glucose measurement without needles.
While such devices may offer convenience, their accuracy remains unverified according to the FDA, posing potential health hazards for individuals managing diabetes and other conditions reliant on accurate blood glucose monitoring.
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