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FDA Warns Consumers Not to Use Smart Watches or Rings That Claim to Measure Blood Glucose Levels
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Thank you, no one ever talks bout this. Maybe the Masimo guy was right. But then why did the the FDA grant approval, and why does Masimo even sell it?
I would think blood oxygen as well. Heart rate too but that one is a lot more apparent and easy to check.
But yes if Apple can't sell watches with blood oxygen sensors because of patents, how is an FDA task force not raiding sellers of these unapproved, life threatening "medical" devices?
I realize it's not the same thing but, uh, priorities I guess.
As long as you don't mind being scammed. These cheap watch glucose monitors are a total scam. All they do is check if it's near mealtime, and they report a higher number because you probably ate a meal. They aren't measuring glucose at all.
100% scam.
Entirely different agencies at work addressing different laws.
Apple was stopped from importing their watches by the ITC. In this case Customs enforces it and otherwise Apple as a giant publicly traded US company isn't going to evade the law.
I bet all these non-invasive blood glucose are made by small foreign companies at best selling on Amazon, etc. They typically market their products as "entertainment" or for general health and wellness (technically outside of FDA oversight -- which is tasked with regulating devices that diagnose and treat disease) The FDA could sue to ban a single company's import but then another one under a slightly different name will just pop up.
Can't tell from your post -- which product's FDA approval are you asking about?
As far as Masimo's medical products, they went through an FDA approval process and are sold and priced as such.
The CVS/etc sold pulse ox devices use some of the same technology (the original concept dates to the 1970s) but are not FDA cleared and typically don't have the calibration nor quality control required of medical devices.
Note that just showing a "general trend" does not exclude a device from FDA oversight. The key is whether the device is being marketed to diagnose or treat disease. The FDA has oversight over those but not over devices sold for general health and wellness or entertainment. Some products aren't obviously one or the other and the FDA has avoided confronting some products in the past but I think is regretting that approach in some cases.
The issue with the non-invasive blood glucose monitoring is that no one has shown a technology that can do it reliably. If someone found a way to do for blood glucose that the pulse ox did for blood O2 saturation, the FDA would eventually start approving medical devices based on such. The FDA will want to see lots of studies first. In the meantime they assume it is not possible. No more useful than Theranos' promises.
I thought Masimo's blood oxygen sensor used in the Apple Watch had to pass FDA approval for reasonable accuracy. Could be wrong.
The concept behind the pulse ox dates back to the 70s. Masimo has improved on it since and protected those ideas with patents. Then different devices have been brought through FDA approval.
Apple (allegedly I guess) copied Masimo's technology and implemented it in the watches. While Apple's sensors and algorithms are (allegedly I guess) similar to Masimo's, FDA approval of Masimo's devices does not confer FDA approval on Apple's devices.
Among other issues, it is the device as a whole -- not just the sensor or the idea behind the sensor -- that gets FDA approval. This makes sense as even among all the cheap pulse ox that are all based on the original concepts, there are wide variations in quality and accuracy. Some possibly accurate enough to be used for medical purposes while some known not to be. If it was based on the concept of the device they would all have to be approved. Additionally the algorithms have significant impact on the measurements so two devices with the same hardware can produce different results -- meaning one could get FDA approval while the other would not.
Finally, though not likely applicable in the pulse ox or similar scenarios, two devices could produce exactly the same results but one would not be approved by the FDA if it had safety issues (e.g. an Xray machine where one machine emitted excess radiation).
P.S.Though it doesn't alleviate the requirement for FDA approval of each device, FDA approval of a device that is substantially similar to an existing approved device is reduced.
For the time being, glucose monitor should only be for healthy person as a preventive method. I use my aWatch heart censors as a monitor that indicates me that all is ok. If ever something is shown wrong I would use a more reliable method. I don’t think glucose monitor (for now) is designed for patients relying on monitoring their glucose level to take the proper dose of their treatment…
Or use something like the Dexcom G7 I've got sitting on my arm right now. Lasts for 10 days and sends glucose values to my iPhone every five minutes. Only catch is... you're not gonna get one unless you're diabetic.
Thing is, apparently the wrist / lower arm is a great place to check your pulse... but not much else.
At last, one that got it right in this thread. AW sensors can be used for screening an apparent healthy population and alarm if something looks strange and point to a medical examination. To judge the real usability of AW as a screening tool, we need to know the percentage false negative as well as the percentage true positive. Still lacks numbers on this. The few stories (by Apple) on "AW saved my life" should therefore be accompanied by stories when AW missed the life threatening condition.
As far as I know it is still not possible to use both devices at the same time, or just your watch. Dexcom has better app support but much bigger sensors.
And if it’s not a scam and product hasn’t been tested properly and malfunctions, and you have type 1 diabetes, and rely on a faulty product, you die! This is t like a blood oxygen sensor that you don’t need to live, you need very accurate bg numbers to dose your insulin and correct lows, or the consequence can be death.
We will see. The current sensors use chemistry based on glucose oxidase. There are many factory that change the color of the blood. Apple needs to solve calibration for each user. Maybe also hormone fluctuations and many other factors you don‘t even think of.
While respecting all those factors we need a high accuracy > 95% and a difference of about 15%, which would be good enough.
1. A Libre2 can run as much as $1050 a month, although negotiated insurance rates can be as little as 1/10th of that rate. So that's at least $1K a year in expenses for the rest of your life.
2. The device can be off in accuracy by > 9%.
3. They can fail completely before their 2 week expiration time.
4. For those who have to monitor their blood sugar accuracy is important. Too low a blood sugar value can put you in the hospital or worse. High blood pressure can do the same but it is not as time sensitive. That's why blood sugar monitors need to be carefully evaluated by the FDA to avoid negative outcomes.
Stupid ass overreach. Why can't I have a glucose monitoring because people are diabetic? Glucose monitoring is amazing for sports.
If people are diabetic and use a sports watch for glucose monitoring, it's their own fault as it is not a medical device.
If people are diabetic and use a sports watch for glucose monitoring, it's their own fault as it is not a medical device.
Indeed. If the Apple Watch Ultra 3 gets this feature, I will actually buy it even though I have an Apple Watch Ultra 2. As this is a game changer.
I think non invasive methods can generate very good relative results but not absolute measurements. So it is possible good to monitor but not for taking the right amount of medicine.
So what are you trying to tell me? The costs are the same compared to the old tests and insurance pays for both of them - at least here in germany