If you are a diabetic or have a chronic respiratory condition, you might be tempted by the idea of using a smartwatch to monitor your blood sugar or oxygen levels. After all, these devices are convenient, discreet, and easy to use. However, before you rush to buy one, you should know that the Brazilian Health Regulatory Agency (Anvisa) has issued a warning about the reliability and safety of these products.
According to Anvisa, any device that performs measurements that are typically used for medical purposes must be regulated by the agency. This includes measurements of glucose, oxygen, blood pressure, electrocardiogram, and irregular heart rhythm. Currently, there are only five software applications for smartwatch that are approved by Anvisa, and they are intended for measuring blood pressure, electrocardiogram, and irregular heart rhythm. There is no device of this type that is authorized for non-invasive measurement of glucose or oxygen, as there is no scientific evidence to support this indication.
Anvisa warns that using unregulated devices for glucose or oxygen measurement can pose serious risks to health, as they may not be accurate or consistent. This can lead to incorrect doses of insulin or oxygen therapy, which can have immediate or long-term consequences, such as hypoglycemic shock or worsening of respiratory conditions. Anvisa also advises consumers to report any advertisements of smartwatch that claim to have the ability to measure glucose or oxygen non-invasively, as this is a sanitary infraction.
Anvisa’s role is to ensure that the devices that are marketed in Brazil have the necessary safety and performance standards to meet their intended use. This requires rigorous scientific studies and tests that demonstrate that the device can achieve its objectives consistently and reliably. Anvisa also monitors the post-market performance of the devices and takes corrective actions if any problems are detected.
Therefore, if you are looking for a device to help you manage your glucose or oxygen levels, you should consult your doctor and choose a product that is regulated by Anvisa. You can check the list of approved devices on Anvisa’s website: https://consultas.anvisa.gov.br/#/saude/