If you see a smartwatch or smart ring on the market that claims to measure blood sugar levels non-invasively, don’t believe it. Today, the Food and Drug Administration Safety communication issued The document warns consumers, patients, and healthcare professionals that the agency “does not authorize, authorize, or approve any smart watch or smart ring intended to independently measure or estimate blood glucose levels.” are doing.
To be clear, no major wearable manufacturer currently offers a smartwatch or smart ring that supports this. All Apple Watch, Fitbit, Samsung watch, or Oura Ring can do is support integration with FDA-approved continuous glucose monitors (CGMs). A CGM is a wearable device that uses a needle to read blood sugar levels. These integrations allow users to monitor data collected from connected CGMs with a companion smartphone app.of Dexcom G7 is one such device.
The FDA’s warning appears to target fraudulent devices that make unsubstantiated claims, rather than these well-known wearable devices.
Unfortunately, trade shows like CES are full of unscrupulous companies promoting smart rings and watches that claim to provide non-invasive blood sugar monitoring. These companies sell these devices directly on their own websites, either through crowdfunding campaigns or through online marketplaces such as Alibaba. If you see a company selling such devices, the FDA urges consumers to report the issue through FDA. MedWatch Voluntary Report Form.
Again, you should be skeptical of wearables that claim to be FDA-approved. In general, while smartwatches and smart rings may have FDA-cleared features (such as electrocardiograms and atrial fibrillation detection), they are not considered medical devices and should not be treated as such.