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TL;DR: The FDA says wearable oximeters have to go through a 90-day review by the agency. Apple hasn’t bothered to try because if they fail then it’s public that the Apple Watch has the capability but isn’t in compliance. Apple could go through the process whenever they want.

I honestly can’t believe this article took as long as it did to explain this. They went through the trouble of explaining what is pretty straightforward and strung it out to make it sound like the FDA bad.

This last paragraph is a joke right?...

Pulse oximetry isn’t as simple as ethyl alcohol production, but it’s a decades-old technology. A company like Apple, with enormous brand equity, is unlikely to release a product that it doesn’t believe will work. The benefits of letting wearers of Apple Watches utilize a function that already lies hidden inside the product would almost certainly exceed the costs. For now, Americans can’t—and they could suffer as a result.

So according to this author, because the tech is old and it’s in a product made by Apple, it must work, but Apple would release a product that it doesn’t think would work. But letting people use it now, even though Apple hasn’t released said feature, it’s okay to start using it without approval because people will die.

How is it that I can buy 100 wearable oxygen sensors on amazon. All these random tiny companies got an fda approval that Apple couldn’t?

Edit:

Garmin watches with spO2 aren’t classified as medical devices and don’t need fda clearance. Why does Apple?

https://buy.garmin.com/en-US/US/p/641435

Right at the bottom of the page:

This is not a medical device

Good thing it has been heavily rumored that this very feature is coming this fall.

Given that the original version of the Apple Watch could apparently do this, I have to suspect this will be part of WatchOS 7 instead of being an Apple Watch 6 exclusive.

Also I’m glad that Apple does its best to comply with the highest standards of medical device regulation - as a user it gives me higher confidence that the data I’m getting is accurate and can be acted upon.

Yeah sure let’s remove regulation and acceptance testing on medical testing devices and let the free market sort it out. What could possibly go wrong with bad readings especially in a time like this?

Ugh... this has annoyed me for 5 years now, who knows if its true, but if it is, ugh.

This sucks, especially if it could help people in the wake of COVID-19. I wonder if this is also holding up the release of the Withings Scanwatch, which is what I’m waiting for.

Well that’s annoying. Can’t have new advancements interfere with drugstore pulse oximeter sales.

Literally can’t get enough of the bullshit posted on this sub. Great entertainment.

Yeah, it's not like allowing an inaccurate device on the market would be harmful or anything....

Sigh.

Most pulse oximeters are transmission-based; i.e. they clamp on a thin part of the body, like a fingertip or earlobe, shine infrared light through it, and monitor the amount of that light which reaches sensors on the other side. Oxygenated blood has different optical properties from non-oxygenated blood, so you can get a sense of blood oxygen content by monitoring the fluctuation in light transmission with the patient’s pulse rhythm.

However, there are many factors that can limit the device’s ability to measure accurately. Dark skin, sweaty skin, or dirty skin can interfere with light transmission. If the extremity is not warmed prior to testing, the blood vessels may be too constricted to take a meaningful reading. Not everyone has the same pattern of blood flow in a given testing area. And there are other conditions that can change the optical properties of blood and make the reading useless.

And that’s a normal pulse oximeter. Wrist devices like the Apple Watch can’t use the light transmission method, so they instead attempt to shine red and infrared light through the skin and measure the difference in the amounts of each frequency that is reflected. And that tends to be even less accurate, especially considering that a thin band around the wrist cannot block nearly as much outside light as a clamp-on device, so the device has a significantly lower signal-to-noise ratio to work with.

Apple has never even tried to have the function tested and approved. The author’s point, that a large company wouldn’t implement a feature unless it would certainly work, is laughable; one need only look at Apple’s recent keyboard woes or the various folding-screen disasters of the past year. The extra oximetry hardware in the Apple Watch is minimal, and chances are the company is simply collecting data in the hopes that, given the write software trained on a vast array of real world measurements, the feature could be implemented more reliably.

Finally, the fact that someone has tried a reflectance method pulse oximeter and got a reasonable reading does not mean the device is accurate and ready for widespread use. First, without comparing results to a proper medical device, you have no idea how accurate the results you’re seeing really are. Second, even if the feature works within a reasonable margin of error for 95% of the time, for a device that’s sold by the tens of millions, that’s millions of people that could be racing to the emergency department for a nonexistent medical condition, or even worse, tens of thousands with a real condition who may ignore other symptoms because a faulty reading told them they‘re OK.

If you want a pulse oximeter, go ahead and buy one. (Preferably the clamp-on type.) But the fact that Apple hasn’t enabled the feature on their device is not proof of government tyranny. Chances are they simply want to avoid a potential PR mess.