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.
Don't forget that checking heart rate or blood oxygen is vastly different than blood glucose, which can easily lead to a medical emergency in a few short minute's time if readings were inaccurate.
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.
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.
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?
The FDA comments have nothing to do with Apple. FDA advises that people should not use smart watches that claim to measure blood glucose levels - cause they don't measure blood glucose levels.
When/If Apple releases a device that measure blood glucose, it will either be a "general trend" and thus not require the whole FDA approval process, or, it will be a device that provides accurate data so that type 1 diabetics can adjust their insulin intake accordingly, and that device will be an FDA approved medical device. IMHO the 2nd one will never be integrated into an AW ...
The technology (to measure blood glucose levels without pricking) is there, or almost there. In order to make it viable, the device has to go through FDA rigor, and that takes years, but those devices will be bailable in the future.
Think body temp measurement, started with putting something in your behind, then mouth, and nowadays your forehead is scanned - enabled through technology...
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.
I thought Masimo's blood oxygen sensor used in the Apple Watch had to pass FDA approval for reasonable accuracy. Could be wrong.
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.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.
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.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…
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.I just ordered the Ultrahuman M1 that will do just that. I believe they are using the FreeStyle Libre CGM. Their app will push the data to Apple Health. Apparently the Freestyle does not...
*Not a diabetic, just interested in a little biohacking data
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.so in other words, if you're not doing the necessary rigor and go the the FDA process and get approval/clearance - you're a scam.
I think I've seen posts here in the AW forums that some chines makers already offer this, so why is Apple behind? - for the above
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.Yet, but can be in the future. Photonics chips are coming in the next 3 years or so and can be reliably used for more than blood glucose monitoring.
That's basically what FDA has said 🙄The FDA's track record doesn't see too great over the last few years so I'm not sure that I would listen to this advice. If I was thinking about getting a monitor, I would have a discussion with my doctor instead.
- If your medical care depends on accurate blood glucose measurements, talk to your health care provider about an appropriate FDA-authorized device for your needs.
What Apple COULD and SHOULD do is to cooperate with the manufacturers of CGM systems like Freestyle Libre 3
It will be incredible if Apple can pull this off. 24/7 blood glucose monitoring would be a game changer. I'd ditch my mechanical watches for this.
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 germany1. 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.