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.
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.
Wednesday March 12, 2025 6:05 am PDT by Joe Rossignol
The upcoming iOS 18.4 update for the iPhone includes a smaller but meaningful improvement for Apple's in-car iPhone mirroring system CarPlay.
Specifically, CarPlay now shows a third row of icons, up from two rows previously. However, this change is only visible in vehicles with a larger center display. For example, a MacRumors Forums member noticed the change in a Toyota Tundra with a...
Tuesday March 11, 2025 3:26 am PDT by Tim Hardwick
Despite being released over two years ago, Apple's AirPods Pro 2 continue to dominate the wireless earbud market. However, with the AirPods Pro 3 expected to launch in 2025, anyone thinking of buying Apple's premium earbuds may be wondering if the next generation is worth holding out for.
Apart from their audio and noise-canceling performance, which are generally regarded as excellent for...
Apple is planning for a major design overhaul of the iPhone, iPad, and Mac interfaces with the introduction of iOS 19, iPadOS 19, and macOS 16 later this year, reports Bloomberg. The update will "fundamentally change" the look of Apple's operating system, introducing a more consistent cross-platform experience.
Apple plans to update the style of icons, menus, apps, windows, and system...
Wednesday March 12, 2025 7:39 pm PDT by Joe Rossignol
Daring Fireball's John Gruber today shared some strongly-worded comments about Apple's delayed personalized Siri features. Gruber is a well-known Apple pundit who has been writing about the company for more than two decades.
In a blog post titled "Something Is Rotten in the State of Cupertino," Gruber said Apple's credibility has been "damaged" by the delay:Keynote by keynote, product by...
Wednesday March 12, 2025 1:05 pm PDT by Joe Rossignol
iPhones are finally getting a much-requested setting, but availability is limited.
The upcoming iOS 18.4 update introduces an option to set a default navigation app, other than Apple Maps, but unfortunately this new setting is limited to users in the EU. There, you can now set an app like Google Maps or Waze as your default navigation app on the iPhone by opening the Settings app and tapping ...
Apple is set to release iOS 18.4 in early April, bringing further refinements to Apple Intelligence features, a neat new capability to iPhone 15 Pro devices, new emoji, and more.
While not quite as packed with new features as Apple's preceding iOS 18 point releases, iOS 18.4 still introduces enhancements that aim to make your iPhone smarter and more intuitive. Below, we've listed 12 new...
Apple One allows you to subscribe to up to six Apple services for one discounted monthly price. There are three Apple One tiers: Individual, Family, and Premier.
Over the last month, the highest-end Apple One Premier plan has gained two additional perks.
Here is what Apple One Premier already included, for $37.95 per month:Apple Music
Apple TV+
Apple Arcade
Apple News+
Apple Fitness+...
Thursday March 13, 2025 3:07 am PDT by Tim Hardwick
Apple's upcoming iPhone 17 Pro models are expected to feature a significant design overhaul, and a new image apparently taken on an assembly line for the unreleased devices appears to confirm the biggest rumored change.
Render of an iPhone 17 Pro model shared by Jon Prosser
The iPhone 17 Pro and iPhone 17 Pro Max are rumored to adopt a horizontal camera bar reminiscent of Google's Pixel...
Wednesday March 12, 2025 2:28 am PDT by Tim Hardwick
Apple is planning a radical redesign of macOS with version 16, and it could be the most significant visual refresh since macOS Big Sur was introduced in 2020, according to Bloomberg.
MacRumors concept render
The upcoming Mac operating system will reportedly be part of Apple's sweeping effort to create a more consistent interface across all of its platforms, including iPhone, iPad, and Apple...
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.
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.
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.
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.
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
"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.
