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Apple Watch ECG Feature Receives Final Medical Approval in Japan

insomniac86 said:
Perhaps the truth is that the Apple Watch’s ECG function is more gimmicky and would fail the review process. Apple wouldn’t want the media attention that there ECG isn’t up to scratch hence they did not want to apply for the review process.
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Pretty much this

They can’t prove it in a market where we have very tough processes to be certified as a medical consumer grade device, Australia.

If it works, and is a medical device then Apple needs to show this. Clearly they can’t so they won’t even submit it for approval.

You can search for any device on the TGA website to see if it’s been submitted. Source it hasn’t!
 
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mavis said:
I wonder if today's watchOS 7 beta will enable this for us ... ? Installing now; fingers crossed.
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And that's a negative. Running iOS 14 beta (the one released yesterday) and the new watchOS beta, it still says ECG not supported in my region.
Hopefully it'll finally be available with the public release of watchOS 7. I mean, I've been waiting for this functionality in this AW since launch day, almost two years ago ... :(
 
bLackjackj said:
Its VERY easy to get the ECG onto the watch, but is it cellular?
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Just saw your post. My watch is a cellular model. Also, I had ECG activated on OS 6, and am now running the OS7 beta, and it's still working, so software updates don't break it. Apparently it's tied to the account as well, so getting a new watch should allow the feature on it. I'm using a series 5 now, and unless it breaks I won't be upgrading until at least the series 7.
 
Led-zep said:
Oh god here comes the anti Australian Govt comments

Sigh. This is apples fault. They haven’t applied for any approvals whatsoever so the fault rests on their shoulders

You want ecg in Australia, I do too, but the onus is on Apple to go through this process as does every other brand who gets things certified

I’m in the industry and Australia’s process is thorough for a reason to protect consumers, I’d rather that then just approve everything with minimal testing

Eg I worked with a brand who has rolled out baby products that are medically certified via the TGA so I know this process very well

If Apple truly believes their ecg can be proven and certified as a medical device they are the ones that need to apply and show this -> they haven’t so clearly their legal team knows they can’t prove their claims true or pass our rigorous testing process
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I’m pretty sure there are published trials to justify the use of Apple watches in measuring ecg changes in out patient settings too.
Out if interest are the previous comments correct about tga requiring exorbitant sums of money for approval?

You’d really think Apple would shell out if this was the case, as one of the main benefits of the Apple Watch over other smart watches thus far is the cellular component?
Only recently available in other brands.

If you have a published way to prove a consumer benefit then you would milk that...
 
insomniac86 said:
Don’t hold your breath, but hopefully the recent changes to the legislation that was introduced in 1989 will accomodate this.

The Australian government is only fast at implementing draconian laws that make them bulk cash.
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I note the Apple Australia website no longer mentions ECG monitoring as a feature of the Apple Watch (as of Apple Watch 6 release). Seems likely never to come to Australia in that case. Emigration seems the only option (the place is stinking hot and burning itself alive in any case).
 
mavis said:
ECG still not available with iOS14 GM + watchOS 7 GM. :confused:
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Nor is it available in today's official iOS 14 release.

"About this Update" notes state "ECG app on Apple Watch Series 4 or later now available in Colombia, Israel, Kuwait, Oman, Qatar, And United Arab Emirates."

:confused: indeed. Oh well, it's only been two years. What's another few weeks?
 
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SaSaSushi said:
Nor is it available in today's official iOS 14 release.

"About this Update" notes state "ECG app on Apple Watch Series 4 or later now available in Colombia, Israel, Kuwait, Oman, Qatar, And United Arab Emirates."

:confused:indeed. Oh well, it's only been two years. What's another few weeks?
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Do you know if it was enabled in the 14.2 beta and/or watchOS 7.1? In the past, they've enabled new regions only when the point update went public (not while in beta) so I'm pretty sure it's not going to work, yet ...
 
mavis said:
Do you know if it was enabled in the 14.2 beta and/or watchOS 7.1? In the past, they've enabled new regions only when the point update went public (not while in beta) so I'm pretty sure it's not going to work, yet ...
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Sorry for the late reply. I don't do WatchOS betas so I don't know whether it's been enabled. If you happen to find out I hope you'll post an update.
 
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SaSaSushi said:
Sorry for the late reply. I don't do iOS betas so I don't know whether it's been enabled. If you happen to find out I hope you'll post an update.
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Ok will do. I don't mind doing betas these days (watchOS 7 was fine, from beta 1) but since they tend to unlock ECG functionality in publicly released point updates, I'm holding off this time. I'd be really annoyed if they finally enabled it for Japan with watchOS 7.0.1 only for me not to be able to use it because I was stuck on 7.2, with no way to downgrade. Lol
 
Just installed the iOS 14.0.1 and watchOS 7.0.1 updates, and Japan is still region-locked. :mad:

Maybe someone at Apple didn't get the memo about the government approval? Or maybe that government approval isn't actually the last step ...
 
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Because iOS 14.2 GM was released today, I thought I'd install it and see if ECG was enabled but apparently Apple doesn't enable region-locked features like it in the betas.

Apple just released the Japanese language help page for ECG as well as the ECG app page in the WatchOS (Japan) App Store so it is almost certainly coming with the official iOS 14.2 release.

With the GM out now hopefully the official release won't be far behind.
 
I just updated my Japanese iPhone 11 Pro Max to iOS 14.2 and Japanese Apple Watch 5 to WatchOS 7.1 and it still says not available in my region. Guess they pulled it last minute. The update also said ECG is now available in South Korea and Russia. No mention of Japan...
 
Indeed, the Japanese ECG function did not make it into the iOS 14.2/WatchOS 7.1 final release for some reason. It looks like we'll have to wait until 14.2.1 which is unfortunate.

It is very strange since apparently the Korean government approval for the ECG came later than Japan's.
 
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