Apple Watch's Sleep Apnea Detection Feature Receives FDA Clearance

[MacRumors]

The U.S. Food and Drug Administration today published clearance of sleep apnea detection on newer Apple Watch models, as reported by TechCrunch.

Sleep apnea is a potentially serious disorder in which a person's breathing repeatedly stops and starts while they sleep.

Apple last week announced that sleep apnea detection would be available on the Apple Watch Series 10, Apple Watch Series 9, and Apple Watch Ultra 2 in the U.S. and more than 150 other countries and regions later this month. Apple's fine print says the feature is intended to detect signs of moderate to severe sleep apnea for people 18 years old or older who have not already been diagnosed with sleep apnea.

The sleep apnea detection feature uses the Apple Watch's accelerometer to "monitor small movements at the wrist that are associated with interruptions in normal respiratory patterns," according to Apple. If these disturbances occur frequently over multiple nights, they may be associated with sleep apnea, according to Apple.

Apple Watch users can view their nightly Breathing Disturbances in the Health app on the iPhone, with disturbances classified as "elevated" or "not elevated."

Apple says the feature was developed using "advanced machine learning" and an "extensive data set of clinical-grade sleep apnea tests," and then validated in a "clinical study."

Apple Watch Series 10 launches on Friday.

Article Link: Apple Watch's Sleep Apnea Detection Feature Receives FDA Clearance

 

[AccenT]

Why can't this be on the Series 9?

Edit: actually seems it will. Good news!

 

[Godspeed8230]

Why can't this be on the Series 9?

Well, it is.

 

[rcarter3636]

I wonder if the high blood pressure detection sensor was close to FDA approval

 

[liberte1776]

This should also be on series 7 which also has the blood oxygen sensor!!

 

[SodaFountain]

There is absolutely no good reason for this feature to not be included on the Gen 1 Ultra. Especially when you consider the Gen 1 has an additional SP02 sensor.
Beyond unacceptable. We should start a petition.

 

[mikebenton]

There is absolutely no good reason for this feature to not be included on the Gen 1 Ultra. Especially when you consider the Gen 1 has an additional SP02 sensor.
Beyond unacceptable. We should start a petition.

These stories are confusing. I have see where the title includes "Apple Watch Ultra" and then in the story it only states "Apple Watch Ultra 2". Then I'll see another story (like this one) that says 'Apple Watch Ultra' throughout.

 

[jz0309]

I assume it requires watchOS 11? Didn’t see that mentioned

 

[jz0309]

This should also be on series 7 which also has the blood oxygen sensor!!

It’s based on accelerometer data, not blood oxygen

 

[citysnaps]

There is absolutely no good reason for this feature to not be included on the Gen 1 Ultra. Especially when you consider the Gen 1 has an additional SP02 sensor.
Beyond unacceptable. We should start a petition.

Are you stepping up to get it going?

 

[jz0309]

There is absolutely no good reason for this feature to not be included on the Gen 1 Ultra. Especially when you consider the Gen 1 has an additional SP02 sensor.
Beyond unacceptable. We should start a petition.

There is no “additional” blood oxygen sensor in the Ultra 1
and this detection is based on accelerometer data, not SpO2

 

[Smittywerben]

There is absolutely no good reason for this feature to not be included on the Gen 1 Ultra. Especially when you consider the Gen 1 has an additional SP02 sensor.
Beyond unacceptable. We should start a petition.

It's probably limited to the newest Apple Watch chip which is S9.
S10 is just rebranded S9.

 

[PsykX]

They're still not making it clear enough if this feature will be available in Canada or not.
For now it's not even on the Series 10 product or comparison page on Apple's website.

 

[SodaFountain]

There is no “additional” blood oxygen sensor in the Ultra 1
and this detection is based on accelerometer data, not SpO2

Additional is the wrong word indeed. All I meant is that it had its oxygen sensor enabled. My point is that it’s just as capable, if not more capable.
Can you provide a legitimate reason as to why this feature isn’t coming to the Ultra 1?

 

[jz0309]

Additional is the wrong word indeed. All I meant is that it had its oxygen sensor enabled. My point is that it’s just as capable, if not more capable.
Can you provide a legitimate reason as to why this feature isn’t coming to the Ultra 1?

I have no insights but it might require the S9 chip which, if I recall right, has 2 neural cores that previous chips did not have.

 

[Crzyrio]

Additional is the wrong word indeed. All I meant is that it had its oxygen sensor enabled. My point is that it’s just as capable, if not more capable.
Can you provide a legitimate reason as to why this feature isn’t coming to the Ultra 1?

The S9 is a big upgrade from the S8 from my understating
- 30% Faster
- Updates to GPU/CUP + Added NPU
- S8 was based of the A13 7nm architecture
- S9 is based of the A15 5nm architecture

It's chip is also the reason why the S9 supports on device Siri, advanced cycle tracking, finger tap gesture etc

 

[Obioban]

Additional is the wrong word indeed. All I meant is that it had its oxygen sensor enabled. My point is that it’s just as capable, if not more capable.
Can you provide a legitimate reason as to why this feature isn’t coming to the Ultra 1?

Ultra 1 doesn't have the neural engine. This is almost certainly running on the neural engine.

Ultra 1 basically had a 4 year old SoC when it launched-- S9 was the first meaningful update in years.

 

[LenardG]

I wonder when EU watches will get it? There has been no news on EU approval yet, at least I did not find it anywhere. Or could the FDA approval be enough to enable it here as well? 🤔

 

[tdar]

I hate it when Apple does something like this. I don’t get it because I have an Ultra 1. It should be on all of the modern watches.

 

[gsurf123]

Apple’s game on medical devices will be a bountiful one. The medical supply companies have been ripping us all off because there was zero competition.

 

[deadlock]

I wonder when EU watches will get it? There has been no news on EU approval yet, at least I did not find it anywhere. Or could the FDA approval be enough to enable it here as well? 🤔

Afib detection came after EU approval of the feature so would imagine that the EU equivalent of the FDA will need to have their say.

 

[teknikal90]

it sucks because true sleep apnea diagnosis machines use blood oxygen sensors. Which has been in the Apple Watch since series 6. but it's not being used because of a patent dispute.

 

[TechnoMonk]

There is absolutely no good reason for this feature to not be included on the Gen 1 Ultra. Especially when you consider the Gen 1 has an additional SP02 sensor.
Beyond unacceptable. We should start a petition.

Most of the functionality happens in the neural engine. I doubt Apple would get an FDA approval with less accurate processing.

 

[hieranonymous]

it sucks because true sleep apnea diagnosis machines use blood oxygen sensors. Which has been in the Apple Watch since series 6. but it's not being used because of a patent dispute.

Yeah, I’m wondering if the sleep apnea detection’s reliance solely on actigraphy is due to the ongoing patent dispute. I feel like additional data from the oxygen sensor could only improve the functionality. It’s really wild how Apple has been shipping disabled O2 sensors in the US for nine months now. I get that they’re playing hardball with a company that they perceive to be a patent troll, but imagine upgrading from an earlier Apple Watch generation and losing access to an entire sensor. Apple needs to sort this out.

 

[jz0309]

it sucks because true sleep apnea diagnosis machines use blood oxygen sensors. Which has been in the Apple Watch since series 6. but it's not being used because of a patent dispute.

This received FDA clearance, what else do you want?