The Agency has published a note specifying that all measuring devices recognized as typically for medical use must be regularised
Summary
Anvisa has issued a note on the risks of using smartwatches to measure blood sugar and oximetry, as no device of this type has been regulated for this purpose. Measurement errors can lead to inadequate treatment of diseases and health violations.
The National Health Surveillance Agency (Anvisa) warned, in a technical note published on Monday (26), about the risks deriving from the use smartwatches to measure glucose in the blood and oximetry (oxygen saturation in the blood). The agency underlines that, to date, no device of this type has been regularized for this purpose in the country.
Currently, only five smartwatch software have been approved by the agency, all intended for measuring blood pressure, electrocardiogram (ECG) and irregular heart rhythm notification.
A Anvis underlines that the sale of medical devices without due regularization constitutes a health infringement, with sanctions provided for by law 6.437/1977. The agency is asking consumers to report advertisements that claim the ability to take non-invasive blood sugar measurements via smartwatches.
For example, the Huawei Watch 4, launched last year, was considered one of the first in the world to measure blood sugar.
Risks of using smartwatches for medical purposes:
- Precision: Anvisa warns that smartwatches do not have the same accuracy as traditional medical devices, which can lead to errors in blood sugar and oximetry measurements.
- Safety: The agency also warns that smart watches have not been tested and approved for medical use, which could pose health risks to users.
- Inadequate treatment: Errors in blood glucose measurement and oximetry can lead to inadequate treatment of diseases such as diabetes and lung diseases.
Anvisa recommends that patients who need to monitor blood sugar or oximetry use traditional medical devices, duly regulated by the agency.
Source: Terra

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