FDA has not reviewed the safety and effectiveness of these devices. Using them could lead to inaccurate blood glucose measurements. If your health heavily relies on precise blood glucose readings, it's advisable to consult your healthcare provider regarding an FDA-approved device that suits your requirements
The FDA is cautioning consumers, patients, caregivers, and healthcare providers about the risks associated with using smartwatches or smart rings that claim to measure blood glucose levels without skin piercing. It's important to note that these devices are not the same as smartwatch apps that display data from FDA-approved blood glucose measuring devices that do require skin piercing, such as continuous glucose monitoring devices. Remember, the FDA has not given authorization for any smartwatch or smart ring to independently measure or estimate blood glucose values.
It's important to be cautious when it comes to purchasing or using smartwatches or smart rings that promise to measure blood glucose levels. These gadgets might be available on online marketplaces or sold directly by the manufacturer.
However, it's crucial to note that the FDA has not reviewed the safety and effectiveness of these devices. Using them could lead to inaccurate blood glucose measurements. If your health heavily relies on precise blood glucose readings, it's advisable to consult your healthcare provider regarding an FDA-approved device that suits your requirements.
Make sure to adhere to the guidelines provided for healthcare providers.
1. Encourage consumers, patients, and caregivers to carefully read and implement the recommendations.
2. Discuss with your patients the potential dangers associated with using unapproved blood glucose monitoring tools.
3. Assist your patients in choosing a suitable, FDA-approved blood glucose monitoring device, if necessary.
Smartwatch and smart ring sellers assert that their devices can measure blood glucose levels without the need for finger pricking or skin piercing. They claim to utilize non-invasive methods. It's important to note that these devices do not directly test blood glucose levels.
These smartwatches and smart rings are produced by various companies and are available under different brand names. This safety advisory pertains to any smartwatch or smart ring that purports to measure blood glucose without skin penetration, regardless of the manufacturer or brand.
The FDA is actively monitoring the medical device market and has discovered unauthorized products being sold to consumers. They are taking steps to prevent manufacturers, distributors, and sellers from illegally promoting unauthorized smartwatches or smart rings that claim to measure blood glucose levels.
It is important for consumers to be aware that smartwatches and smart rings should not be relied upon to measure blood glucose levels. The FDA will continue to update the public with any important developments.
If you suspect that your blood glucose measurement is inaccurate or if you encounter any negative effects from using an unauthorized smartwatch or smart ring, the FDA urges consumers to report the issue using the MedWatch Voluntary Reporting Form.
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