FDA Warns Consumers Not to Use Smart Watches or Rings That Claim to Measure Blood Glucose Levels (2024)

by Juli Clover

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.

FDA Warns Consumers Not to Use Smart Watches or Rings That Claim to Measure Blood Glucose Levels (1)
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

[ 96 comments ]

Top Rated Comments

DoogH

1 day ago at 01:05 pm


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: 23 Votes (Like | Disagree)

dannyyankou

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: 18 Votes (Like | Disagree)

Chazak

23 hours ago at 01:48 pm

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: 15 Votes (Like | Disagree)

aperantos

1 day ago at 01:15 pm


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)

JapanApple

1 day ago at 01:13 pm

"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)

jz0309

1 day ago at 12:53 pm

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: 5 Votes (Like | Disagree)

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FDA Warns Consumers Not to Use Smart Watches or Rings That Claim to Measure Blood Glucose Levels (2024)

FAQs

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

FDA Warns Against Using Smartwatches or Smart Rings to Measure Blood Glucose Levels. The agency issued a statement reminding the public that it has not approved any such devices for this use. Your watch might be smart, but it's not smart enough to measure your blood glucose levels.

What is the FDA warning on smart watches? ›

The Food and Drug Administration (FDA) issued a warning late this week to advise consumers, caregivers, and health professionals about the risks of using smartwatches and smart rings to monitor glucose levels. Accurate glucose monitoring is essential for people living with diabetes.

Is the FDA warn against using smart wearables that claim to measure blood sugar? ›

Date Issued: February 21, 2024

The U.S. Food and Drug Administration (FDA) is warning consumers, patients, caregivers, and health care providers of risks related to using smartwatches or smart rings that claim to measure blood glucose levels (blood sugar) without piercing the skin.

Can a smartwatch really measure blood glucose? ›

Watches or rings that claim to directly measure blood glucose levels via non-invasive tech are illegally marketed. Image credit: Shutterstock/Eviart. No, smartwatches cannot directly measure glucose levels.

Are smart watches bad for your health? ›

Excessive use of smartwatches can have some side effects. Some of the most commonly known concerns include radiation, eye strain, and distraction. The Bluetooth and Wi-Fi signals emitted by smartwatches could be harmful to health, but there is currently no scientific evidence to support this claim.

What are the safety warnings of smart watches? ›

US drug agency has an 'important' warning for smartwatch and smart ring users. The US Food and Drug Administration (FDA) issued a strong warning recently advising consumers not to use smartwatches or wearable devices that claim to measure blood glucose levels without piercing the skin.

Do smartwatches have medical alert? ›

Can you use a smartwatch as a medical alert device? Yes, medical alert smartwatches connect to a 24/7 monitoring center during an emergency. Many medical alert watches have fall detection, GPS location tracking, step tracking, and even a weather app.

Does the Apple Watch measure blood sugar? ›

While the Apple Watch itself doesn't directly measure blood glucose levels, it can integrate with third-party continuous glucose monitoring (CGM) devices. This allows users to receive real-time blood glucose readings directly on their watch face, eliminating the need for constant finger pricks.

Can smart watches really measure blood oxygen? ›

You Can Measure Blood Oxygen Saturation with a Smartwatch

Since these watches don't use medical-grade sensors, you still need to measure blood oxygen saturation information using a pulse oximeter.

Why I stopped wearing a smartwatch? ›

I am free from the limiting belief that my smart watch knows better than my body's own intuition. I don't need it to tell me when to get up. My body lets me know when I have been sitting down for too long. I am free from the limiting beliefs that if those circles don't close, I didn't 'do well' today.

Why I stopped wearing Apple Watch? ›

I'm happier and healthier without it. I originally purchased a smartwatch to increase my step count and track my workouts. As it began to track more data, I spiraled into a world of obsessive checking and health anxiety. Since giving up my smartwatch, I've dramatically improved my physical and mental health.

What is the EMF radiation of a smart watch? ›

According to research, the average EMF output of a smartwatch is approximately 0.01 to 0.1 watts per kilogram (W/kg) of body tissue, while the average EMF output of a smartphone is approximately 0.5 to 1.6 W/kg.

Are Samsung watches FDA approved? ›

Samsung Galaxy Watch gets first-ever FDA clearance for sleep apnea detection. Later this year, your Galaxy Watch will be able to detect early symptoms of a dangerous condition.

Is Samsung smart watch FDA approved? ›

The Galaxy Watch's sleep apnea feature has received approval from the US Food and Drug Administration, the tech giant announced on Friday, in the latest sign that sleep is a big part of Samsung's health-tracking ambitions.

Is The Apple Watch FDA approved? ›

The irregular rhythm notification feature received 510(k) clearance from the FDA for users 22 years and older with no prior history of AFib.

Does the FDA warn against smartwatches and rings that claim to measure blood sugar without needles? ›

FDA warns against smartwatches, rings that claim to measure blood sugar without needles. Smartwatches and rings that claim to measure blood sugar levels for medical purposes without piercing the skin could be dangerous and should be avoided, the U.S. Food and Drug Administration warned Wednesday.

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