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

Popular Stories

iPhone 17 Pro Blue Feature Tighter Crop

iPhone 17 Pro Launching Later This Year With These 13 New Features

Wednesday April 23, 2025 8:31 am PDT by
While the iPhone 17 Pro and iPhone 17 Pro Max are not expected to launch until September, there are already plenty of rumors about the devices. Below, we recap key changes rumored for the iPhone 17 Pro models as of April 2025: Aluminum frame: iPhone 17 Pro models are rumored to have an aluminum frame, whereas the iPhone 15 Pro and iPhone 16 Pro models have a titanium frame, and the iPhone ...
iphone 17 dummies sonny dickson

iPhone 17 Air Almost as Thin as Its Buttons, New Images Show

Thursday April 24, 2025 2:14 am PDT by
If you missed the video showing dummy models of Apple's all-new super thin iPhone 17 Air that's expected later this year, Sonny Dickson this morning shared some further images of the device in close alignment with the other dummy models in the iPhone 17 lineup, indicating just how thin it is likely to be in comparison. The iPhone 17 Air is expected to be around 5.5mm thick – with a thicker ...
iPhone 17 Air Pastel Feature

iPhone 17 Air Launching Later This Year With These 16 New Features

Thursday April 24, 2025 8:24 am PDT by
While the so-called "iPhone 17 Air" is not expected to launch until September, there are already plenty of rumors about the ultra-thin device. Overall, the iPhone 17 Air sounds like a mixed bag. While the device is expected to have an impressively thin and light design, rumors indicate it will have some compromises compared to iPhone 17 Pro models, including only a single rear camera, a...
AirPods Pro 3 Mock Feature

AirPods Pro 3 Just Months Away – Here's What We Know

Friday April 18, 2025 5:16 am PDT by
Despite being more than two years old, Apple's AirPods Pro 2 still dominate the premium wireless‑earbud space, thanks to a potent mix of top‑tier audio, class‑leading noise cancellation, and Apple's habit of delivering major new features through software updates. With AirPods Pro 3 widely expected to arrive in 2025, prospective buyers now face a familiar dilemma: snap up the proven...
iphone 17 air dummy unbox therapy

iPhone 17 Air's Extreme Thinness Demoed in New Video

Tuesday April 22, 2025 10:22 am PDT by
Apple plans to release an all-new super thin iPhone this year, debuting it alongside the iPhone 17, iPhone 17 Pro, and iPhone 17 Pro Max. We've seen pictures of dummy models, cases, and renders with the design, but Lewis Hilsenteger of Unbox Therapy today showed off newer dummy models that give us a better idea of just how thin the "iPhone 17 Air" will be. The iPhone 17 Air is expected to be ...
Global Close Your Rings Day Pin

Apple Stores Giving Away a Limited-Edition Pin For Free Today

Thursday April 24, 2025 10:15 am PDT by
Starting today, April 24, Apple Stores around the world are giving away a special pin for free to customers who request one, while supplies last. Photo Credit: Filip Chudzinski The enamel pin's design is inspired by the Global Close Your Rings Day award in the Activity app, which Apple Watch users can receive by closing all three Activity rings today. The limited-edition pin is the physical...
Apple Logo Spotlight Blue

White House Hits Back at Apple's Massive EU Fine

Thursday April 24, 2025 5:57 am PDT by
Apple's $570 million fine from the EU has triggered a sharp rebuke from the White House, which called the fine a form of economic extortion, Reuters reports. The fine was announced on Wednesday by the European Commission, following a formal investigation into Apple's compliance with the bloc's Digital Markets Act (DMA), a landmark piece of legislation aimed at curbing the market dominance of ...
ipad air magic keyboard feature

iPadOS 19 Rumored to Show Mac-Like Menu Bar When Connected to Magic Keyboard

Thursday April 24, 2025 12:09 pm PDT by
When an iPad running iPadOS 19 is connected to a Magic Keyboard, a macOS-like menu bar will appear on the screen, according to the leaker Majin Bu. This change would further blur the lines between the iPad and the Mac. Bloomberg's Mark Gurman previously claimed that iPadOS 19 will be "more like macOS," with unspecified improvements to productivity, multitasking, and app window management,...

Top Rated Comments

DoogH Avatar
15 months 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
15 months 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
15 months 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
15 months 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
15 months 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
15 months 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)