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If you need to wear the watch every night while sleeping, when do you charge it? Serious question.
 


Looks like they submitted as class II device?

Post Approval, this will be considered as a medical data (?), i am curious to see how both Apple and FDA will treat third party apps that requests data from apple health (if). Will they be subjected to HIPAA Controls as patient identity is involved here?
Will FDA enforce same fair rules on apple in protecting patient? (recalls, thefts etc etc)

[These are rhetorical questions, I am curious to see how apple defines its framework in either collecting or restricting certain data].

I am also excited to see responsibility behind apple touting apple watch as a health device for years, and adding strong legitimacy behind it finally. it is a good start and can only open gates to other features, just looking at their list of FDA Submissions.

also interested to see if insurance companies will have a coverage/subsidize based on doctor's prescriptions.

Win win for users.
 
It’s really infuriating. You buy Apple’s next-gen top of the line watch, and they gatekeep seemingly trivial-to-them to implement, but could beneficial to the people that bought their $$$ trinket.

Missing out on the two finger pinch/tap from the Ultra 2/Series 9 was a slap in the face, but leaving us out of the sleep apnea seems feels like a kick in the nuts.

Especially when I’d think that people keep their watches longer than phones.

Also the neutral engine.
 
I tried it for a while but it made me sleep so badly because mentally I was trying to get the perfect sleep, which put me under unreasonable pressure to sleep and as a result I couldn’t sleep 😅

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Btw the Galaxy Watch 7 version of this is already FDA approved and does it in combination with the Blood Oxygen measurement. Oh and it even works on older watches with an update! Apple would never
Hehe. Mine is more of being aware of the watch while I’m trying to sleep. I better not be under house arrest.
 
Most likely due to the cost of getting FDA approval for a device that has been off the market for awhile.

Recently my veterinarian prescribed an off-label drug for my cat that is only FDA approved for dogs. She said studies show it is safe and effective for cats but the drug company doesn’t want to spend money on approval for cats. So yeah, it’s a cost thing.
But conspiracy theories sound more exciting and satisfying. Apple will have to get approvals for future models, that may limit what they can roll out every year. I guess we me start seeing color updates one year and features that need approvals every 2 years.
 
If you need to wear the watch every night while sleeping, when do you charge it? Serious question.
For 30-40 minutes in the evening before bedtime. Or throw it on the charger during dinner time. Or while you're in the shower/getting dressed in the morning. It's not an all-day/all-night procedure to charge a watch.
 
I was excited for and about to treat myself to the Milanese loop band to smarten up my OG AW Ultra for dress wear, even though it’s pricey…..then I read this!
I sometime wake up at night and wonder if I have sleep apnea so would love this feature. I paid £899 not two years ago for the watch. However, if this doesn’t come to the OG AW, then I’m keeping my money.
 
But conspiracy theories sound more exciting and satisfying. Apple will have to get approvals for future models, that may limit what they can roll out every year. I guess we me start seeing color updates one year and features that need approvals every 2 years.
I'm not sure how it works going forward, but safe to say they submitted for approval using the AW9 and UW2 as those were in production at the time. Future models may need approval if there are significant design changes.
 
This should be an all Apple Watch feature. I wear the Apple Watch Ultra to bed but.. To be honest I started to get a rash no matter which band I wore. I live on a farm and deal with hay and the sorts so by wearing it at night and being that I always over heat I found it best to give my wrist a break. To be honest ... Apple should have surprised us and broke the patent or bought the Oura ring as that feels more comfortable. So .. I wear the watch every so often to bed..
 
This should be an all Apple Watch feature. I wear the Apple Watch Ultra to bed but.. To be honest I started to get a rash no matter which band I wore. I live on a farm and deal with hay and the sorts so by wearing it at night and being that I always over heat I found it best to give my wrist a break. To be honest ... Apple should have surprised us and broke the patent or bought the Oura ring as that feels more comfortable. So .. I wear the watch every so often to bed..
AFAIK existing over the counter sleep apnea devices include a wrist mounted device (much larger than a watch), a fingertip blood oxygen sensor, and a chest sensor - not fun to sleep with. if Apple can pull this off with just the watch that would be pretty incredible.
 
I found it very strange that Apple did a whole workaround not to use the blood oxygen monitor to detect sleep apneas, after all it is available everywhere except the US. I am curious if sleep apnea works with help of that sensor outside the US.
 
If you need to wear the watch every night while sleeping, when do you charge it? Serious question.
If you have the Sleep function enabled (gives you bedtime and a wake up alarm) the watch will prompt you to "charge before going to bed" once you get below a certain battery %... As long as you are chasing on a decent power brick (USB-C) it will give you a full charge in a fair amount of time.

So basically, plan to charge an hour or so BEFORE you normally lay down every other day. (That's what works for me anyway)
 
I found it very strange that Apple did a whole workaround not to use the blood oxygen monitor to detect sleep apneas, after all it is available everywhere except the US. I am curious if sleep apnea works with help of that sensor outside the US.
It is most likely to avoid a patent infringement. I'm no expert, I'd be surprised if they aren't using the O2 sensor at all in this. Maybe just listing it as a subsequent item/process and not the primary? To make it just different enough.
 
So to get this feature you don’t need to get the new series 10? My AWU 2 will have it with just an update?

Considering all they did was add a color to the AWU2 and Apple said it would, yes.

Missing out on the two finger pinch/tap from the Ultra 2/Series 9 was a slap in the face, but leaving us out of the sleep apnea seems feels like a kick in the nuts.

You can get it, sort of, with accessability, I used it until I bought my AWU2; but yea, I'm wondering what teh technological issue is with the AWU1.

Most likely due to the cost of getting FDA approval for a device that has been off the market for awhile.

They aren't getting approval, just clearance.

Every doctor and nurse I've met and have, had said that wrist pressure cuffs are not as accurate as arm pressure cuffs.

Well, Apple isn't making medical devices but a consumer device that can measure trends and use it to notify someone of a potential problem. The ECG isn't going to be used by a cardiologist for a diagnosis but if it deters AFIB you might want to go to one to see what's up. Same with some of the exercise analysis. Think trends, not diagnostic accuracy.
 
They aren't getting approval, just clearance.
Marketing clearance? So would it make sense to get clearance for older products that are no longer being marketed?

Also I think the FDA calls it "marking approval." EDIT I see it will probably be a 510(k) premarket notification clearance for the device. "Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or indications for use."
 
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Apple is reaching for reasons to get users to upgrade on this product, lose Blood O, toss in sleep apnea.
 
I'm tempted to upgrade my watch early for this feature alone.

My doctors office "insists" I don't have sleep apnea despite having all the symptoms, friends of mine both doctors and nurses all say they can hear my breathing stop while sleeping (they all heard me on many camping trips), even my dentist says they can tell by something in my throat I have sleep apnea.

But no no...a single broken take home unit that stopped working right after I put it on says I dont have it so I must not have it *eyeroll*.

Rather just change the doctor and go to someone who’s not so flippant about it.
 
Rather just change the doctor and go to someone who’s not so flippant about it.
The biggest issue is my insurance. Because that stupid stay home test said I didn't have it insurance won't cover a lab study. I worded it badly above I should have said insurance vs doctors office.
 
To get more accurate results, the oxygen levels need to be monitored. That won’t happen with what Apple has talked about in the article.
Not every Apple customer lives in the US. I would assume Apple would use SpO2 as well as motion (and possibly using the sounds people make) outside the US.
 
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