FDA Warns Consumers Not to Use Smart Watches or Rings That Claim to Measure Blood Glucose Levels

The United States Food and Drug Administration (FDA) does not want consumers to purchase or use smart watches or smart rings that claim to measure blood glucose levels using non-invasive methods. In a safety warning shared today, the FDA says that smart devices that claim to check blood sugar without piercing the skin can lead to errors in diabetes management, including taking too much or too little medication.

Apple Watch Blood Glucose Monitoring Feature 2
No smart watch or smart ring that is intended to measure or estimate blood glucose values non-invasively has been authorized, cleared, or approved by the FDA. These non-invasive devices are different from continuous glucose monitoring devices (CGMs) that relay data through a smart watch app.

Apple is rumored to be working on a version of the Apple Watch that will be able to measure blood glucose non-invasively, but launch of such a device is still several years away. Apple has been exploring optical absorption spectroscopy using a laser to shine light under the skin to determine a person's blood glucose level, but as of 2023, Apple's work remained at a proof-of-concept stage.

As of right now, there are several low-cost smart watches and smart rings that claim to be able to monitor glucose levels without a skin prick or without integrating with a CGM device. The FDA says patients should avoid such devices, and doctors should warn patients about the risks of using unauthorized blood glucose measuring products.

Sellers of these smartwatches and smart rings claim their devices measure blood glucose levels without requiring people to prick their finger or pierce the skin. They claim to use non-invasive techniques. These smartwatches and smart rings do not directly test blood glucose levels.

These smartwatches and smart rings are manufactured by dozens of companies and sold under multiple brand names. This safety communication applies to any smartwatch or smart ring that claims to measure blood glucose without piercing the skin, regardless of manufacturer or brand.

The FDA says that it is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smart watches or smart rings that claim to measure blood glucose levels.

If Apple does end up releasing an Apple Watch that includes a sensor for non-invasive blood glucose monitoring, Apple will need to get FDA approval before it is allowed to sell it in the U.S. Other companies like Samsung are working on similar technology, but there is no proven and approved non-invasive blood sugar monitoring method on the market as of right now.

Tag: FDA

Top Rated Comments

DoogH Avatar
8 weeks ago

The FDA wants their money of course, but also yikes when the FDA actually makes a comment on something like this. Does not bode well for anyone hoping for an advancement in this tech anytime soon.
FDA doesn't get paid for this.

The issue is that nobody has made a reliable blood monitor. Not even close.

I mean, check the oxygen sensor, mine regularly drops to 88% on my watch, but is never below 98% when I go to the doctor.
Score: 24 Votes (Like | Disagree)
dannyyankou Avatar
8 weeks ago
There's nothing wrong with using this tech. But it shouldn't be a substitute. If my Apple Watch says my heart rate spiked, I verify with a blood pressure monitor that shows heart rate data.
Score: 20 Votes (Like | Disagree)
Chazak Avatar
8 weeks ago
It is a sad statement about the world we live in when people think the FDA is partaking in some kind of scam or has something to gain from warning people not to rely on devices not meeting the criteria to be an approved medical device.
Score: 17 Votes (Like | Disagree)
aperantos Avatar
8 weeks ago

There is another solution for both cases: Just let a doctor check it…
It is as easy as that. Then you get an approved diagnose.
Diabetics cannot see a doctor any time they want to eat! Glucose monitoring it an essential part of insulin management so it needs to be self monitored, which is why the FDA is issuing this warning. If something gives a reading that is either too high or too then you can risk your health taking the wrong dose. There are international standards on the safe margins of error that devices need to achieve to be certified.
Score: 10 Votes (Like | Disagree)
jz0309 Avatar
8 weeks ago
and for this retirement, the AW will never (imho) provide CGM (continuous glucose monitoring) as that would make it a medical device (read very expensive). now they might make a "special edition", or, they'll negotiate with the FDA to provide "trends", lacking actual data, just saying high, low etc
Score: 6 Votes (Like | Disagree)
JapanApple Avatar
8 weeks ago
"The FDA says patients should avoid such devices, and doctors should warn patients about the risks of using unauthorized blood glucose measuring products."

Agreed, Apple devices or no Apple devices, these are only guesstimations at the least. Always use reliable methods.
Score: 6 Votes (Like | Disagree)

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