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USA: FDA warns against blood glucose measurement from smartwatch

In the USA, the FDA has issued an official warning about smart devices that can be used to measure blood glucose levels. According to the authority, such smartwatches and smart rings are extremely unreliable and therefore dangerous.

Smartwatch unreliable when measuring blood sugar

Anyone wishing to market a medical device in the United States of America cannot avoid the Food and Drug Administration (FDA). The health authority decides whether a gadget is actually classified and approved as a medical device. Experience has shown that the FDA is much more willing to approve such matters than its EU counterpart. For example, it did not take long for the authority to approve Apple and other smartwatch manufacturers as reliable ECG measuring devices.

When it comes to diabetes, however, the health experts seem to take a somewhat stricter view. The FDA has now officially warned against gadgets that promise to measure blood glucose levels. There are now smartwatches and smart rings that are supposed to offer this feature. As part of an approval procedure, the authorities have probably tested several devices for this function. The result was not only the lack of approvals, but also a firm warning about the function. The warning is not only addressed to people with diabetes. Nursing staff should also urgently refrain from using it.

Concerns non-invasive methods

A lot has happened in the field of blood glucose monitoring in recent years. There are now small-format measuring devices that enable permanent monitoring of blood glucose levels using an app. These are one thing above all: reliable. However, the big difference to a smartwatch and smart rings is the fact that their measurement is carried out using extremely thin needles that can directly analyze the wearer’s blood. Since such gadgets can now also work perfectly with devices such as an Apple Watch or a smart ring, users hardly have to accept any loss of comfort.

Who will make the breakthrough with the smartwatch?

Pulse, blood pressure, oxygen saturation – many vital signs can be measured without having to prick the person concerned. However, this is still not possible when measuring blood glucose levels. In fact, this is an area of medical research on which many scientists are working at full speed. Of course, a non-invasive solution would be a real breakthrough. At the same time, however, well-known tech companies such as Apple and Samsung are also working on a solution to the problem. However, Apple claims to have already found a suitable solution for measuring blood glucose without a needle prick.

smartwatch
Reliable and convenient measurement has so far only been possible with invasive devices such as the Dexcom models

However, the prototype is still far too large to fit into an Apple Watch, let alone a smart ring. Apple is currently working at full speed on the latter, as various patent applications suggest. Even though two of the world’s largest tech companies will probably still need years to produce a finished product, a few flimsy providers already want to have a suitable smartwatch up their sleeves and even sell it. The FDA has issued a clear warning about these models and is even asking US citizens for help. Anyone who comes across such a product should report it to the authority immediately.

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In the USA, the FDA has issued an official warning about smart devices that can be used to measure blood glucose levels. According to the authority, such smartwatches and smart rings are extremely unreliable and therefore dangerous. Smartwatch unreliable when measuring blood sugar Anyone wishing to market a medical device in the United States of America cannot avoid the Food and Drug Administration (FDA). The health authority decides whether a gadget is actually classified and approved as a medical device. Experience has shown that the FDA is much more willing to approve such matters than its EU counterpart. For example, … (Weiterlesen...)

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