ECG might not happen this year

[Cordorb]

"The Food and Drug Administration’s quick approval of new mobile medical apps designed for the Apple Watch is raising eyebrows among FDA observers who say the tech behemoth got preferential treatment."

And we thought FCC approval was hard.

also In fact, the FDA’s letters to Apple classifying the watch’s software as a Class II device—dated Sept. 11 ), the day before the launch event—state that the ECG app is not intended for use by people under age 22.

AND this is USA only -- I think ?

sorry forgot the link

https://www.fiercebiotech.com/medtech/new-apple-watch-receives-fda-clearance-for-built-ecg

 

[tl01]

Let's wait until the end of the year before we get angry. Phone and online support are not told about release dates ahead of anyone else.

 

[Vermifuge]

Let's wait until the end of the year before we get angry. Phone and online support are not told about release dates ahead of anyone else.

Oh I don't think anyone is angry. Just not taking Apples word at face value due to recent circumstances. It's a double edged sword...

CAMP A: Apple is too secretive and needs to be more transparent about new products and release dates.
CAMP B: Apple needs to wait until product is ready before making an announcement.

A&B: Apple needs to stop releasing unfinished products and not rely on software updates to issues post launch

 

[deeddawg]

Spoke to an online support for Apple and

Call center workers are great people, but they RARELY(*) have any actual knowledge of the real status of high level corporate initiatives -- such as the status of ECG rollout.

I honestly wouldn't get worked up over what that individual stated. They might be right, they might be wrong, but whichever it is most likely is a guess on their part and not actual knowledge. Information on the actual status of stuff like that is going to be fairly closely held by the team(s) involved -- and not broadcast throughout the company.

Just my opinion from many years working in mid to large corporations.

(*) sure there are scenarios we can imagine where such information is known by the callcenter staff, but those are going to be far more the exception than the rule.

 

[newellj]

"The Food and Drug Administration’s quick approval of new mobile medical apps designed for the Apple Watch is raising eyebrows among FDA observers who say the tech behemoth got preferential treatment."

And we thought FCC approval was hard.

also In fact, the FDA’s letters to Apple classifying the watch’s software as a Class II device—dated Sept. 11 ), the day before the launch event—state that the ECG app is not intended for use by people under age 22.

AND this is USA only -- I think ?

sorry forgot the link

https://www.fiercebiotech.com/medtech/new-apple-watch-receives-fda-clearance-for-built-ecg

Definitely USA only. Interesting note on age. I wonder if Kardia devices have the same limitation (will Google). Edit: from the AliveCor website: "Our devices have not been tested for and are not intended for pediatric use."

 

[Vermifuge]

Call center workers are great people, but they RARELY(*) have any actual knowledge of the real status of high level corporate initiatives -- such as the status of ECG rollout.

I honestly wouldn't get worked up over what that individual stated. They might be right, they might be wrong, but whichever it is most likely is a guess on their part and not actual information. Information on the actual status of stuff like that is going to be fairly closely held by the team(s) involved -- and not broadcast throughout the company.

Just my opinion from many years working in mid to large corporations.

(*) sure there are scenarios we can imagine where such information is known by the callcenter staff, but those are going to be far more the exception than the rule.

I hate that there are so many self appointed lawyers on discussion forms that one needs to include citations when making a post.

 

[Renjo2007]

If they failed to deliver ECG until the next watch then I will demand a replacement at that time. I will not even accept an IOS update just before a new watch. The ECG was a major announcement point and selling point.

Same opinion here. Can i just return my S4 SS for a full refund if ECG is not delivered later this year.

 

[deeddawg]

Same opinion here. Can i just return my S4 SS for a full refund if ECG is not delivered later this year.

Highly unlikely.

If ECG is a defining reason for you to have the watch, then go return it now. Wait until the feature is actively available. Then go buy the watch.

Never buy something today specifically for a future promised feature that isn't currently extant.

 

[Renjo2007]

Highly unlikely.

If ECG is a defining reason for you to have the watch, then go return it now. Wait until the feature is actively available. Then go buy the watch.

Never buy something today specifically for a future promised feature that isn't currently extant.

Yup it is the main reason I bought it and sadly I’m past the 14 day return window already.

 

[tromboneaholic]

... just like they showed us AirPower
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I don't think you'll see it before aw5 is out...

Technically AirPower isn't late yet, but from what I've read they are having hardware and engineering issues which is why it didn't debut alongside iPhone XS & Max.

The hardware for ECG seems to be complete, and it has been cleared by the FDA, so it seems like Apple is just finalizing the software before release.

The bottom line is there is no reason to be up in arms at this point.

 

[dojoman]

A&B: Apple needs to stop releasing unfinished products and not rely on software updates to issues post launch

Apple Watch Series 4 not unfinished product. If by your definition then anything that receives software update via firmware would be considered unfinished. ECG is a feature that will be enabled via software. You don't have to buy the watch now if you really just want to use ECG feature, people buy it for other reasons.

 

[Vermifuge]

Apple Watch Series 4 not unfinished product. If by your definition then anything that receives software update via firmware would be considered unfinished. ECG is a feature that will be enabled via software. You don't have to buy the watch now if you really just want to use ECG feature, people buy it for other reasons.

...

I hate that there are so many self appointed lawyers on discussion forms that one needs to include citations when making a post.

What definition? I said there seems to be these two camps that complain about everything. Why are you making assumptions about what my definitions are?

After AirPower I suspected this was a possibility (As is eSIM) I decided i wouldn't get the S4 unless this feature was enabled. After all, i'm perfectly happy with my S3 and the other enhancements are superficial.

You don't have to justify your purchase to me. I get all day battery life with my S3 and have used my LTE service all of 3 times. 2 of those were demonstrating it for the people.

Certainly wouldn't mind a larger display but but not forking over the money until the ECG is activated.

So i have an opinion that differs from yours... And i already stated i'll wait it out. I have no problem with my S3 and a few months really doesn't bother me.

Oh I don't think anyone is angry. Just not taking Apples word at face value due to recent circumstances.

See? It''s cool. I'm just chilling reading how everyone else is or is not enjoying their S4.

 

[ActionableMango]

Apple has provided the technology, it works and its included in the device. It's up to the laws and regulators in that country to allow the feature to be used. Without approval from regulators for that country, it will be illegal to sell the product.

So perhaps shift your blame from Apple and request approval from your government.

The FDA has already cleared it. So if it works and it is included, as you state, what exactly are we waiting for?

Furthermore, the government didn't promise anything by the end of the year. Apple has.

 

[TheIguana]

The FDA has already approved it. So if it works and it is included, as you state, what exactly are we waiting for?

Furthermore, the government didn't promise anything by the end of the year. Apple has.

Ahem, hold up there, the ECG feature has been given preliminary FDA Clearance. That is VERY different from FDA Approval.

 

[ActionableMango]

Ahem, hold up there, the ECG feature has been given preliminary FDA Clearance. That is VERY different from FDA Approval.

Okay, I've changed my wording. But your article states that FDA doesn't do approvals for Class II devices like the AW because no approval is needed.

So my point still stands. FDA is not holding this up--they've cleared it. That was the context of what I was replying to. The FDA letter states:

As a result of this order, you may immediately market your device as described in the De Novo request, subject to the general control provisions of the FD&C Act and the special controls identified in this order.​

Also, what do you mean by "preliminary" clearance? That implies that further regulatory approval from the FDA is needed.

 

[Vermifuge]

Okay, I've changed my wording. But your article states that FDA doesn't do approvals for Class II devices like the AW because no approval is needed.

So my point still stands. FDA is not holding this up--they've cleared it. That was the context of what I was replying to.

Also, what do you mean by "preliminary"? I saw no such implication in the article. The FDA letter states:

As a result of this order, you may immediately market your device as described in the De Novo request, subject to the general control provisions of the FD&C Act and the special controls identified in this order.​

Same. From what I have ready the FDA has given the go-ahead to Apple.

 

[newellj]

I just went to the Apple Watch pages on Apple's website, and it is there, in plain text:

ECG app coming later this year.

Irregular rhythm notification coming later this year.

It's actually hard to believe Apple would put that in writing on its website if it weren't very sure these will happen. OTOH, the wOS 5.1 beta doesn't have either app.

 

[Vermifuge]

I just went to the Apple Watch pages on Apple's website, and it is there, in plain text:

ECG app coming later this year.

Irregular rhythm notification coming later this year.

It's actually hard to believe Apple would put that in writing on its website if it weren't very sure these will happen. OTOH, the wOS 5.1 beta doesn't have either app.

Could you do me a favor and go to apple.com and lookup when AirPower is coming out?

 

[newellj]

Could you do me a favor and go to apple.com and lookup when AirPower is coming out?

Right. That's the point - you can't. With these two apps/functions, you can. It is actually written, posted on the Apple website. There is no way Apple could backtrack on this without massive legal, financial, regulatory and consumer backlash.

Further, since they've received FDA clearance, it's hard to imagine any reason for them to do so.

The only interesting theory I can think of is that perhaps they ran into a patent issue with AliveCor and they're trying to sort it out before they roll out the app and start the legal damages clock.

 

[Vermifuge]

Right. That's the point - you can't. With these two apps/functions, you can. It is actually written, posted on the Apple website. There is no way Apple could backtrack on this without massive legal, financial, regulatory and consumer backlash.

AirPower was also until they Removed every trace of it from the website. ¯\_(ツ)_/¯

 

[newellj]

AirPower was also until they Removed every trace of it from the website. ¯\_(ツ)_/¯

I don't remember that (but I'm not disputing it). I wonder if The Wayback Machine has those pages...

There is another precedent in this general area that is not encouraging at all. Three points to the person who names it first. (Warning: point have no cash value. )

 

[Vermifuge]

I don't remember that (but I'm not disputing it). I wonder if The Wayback Machine has those pages...

There is another precedent in this general area. Three points to the person who names it first. (Warning: point have no cash value. )

https://web.archive.org/web/20171130222608/https://www.apple.com/iphone-x/

 

[newellj]

YTM!!! It's still very different, though. They never actually took anyone's money for that. The S4 AW, on the other hand, has apparently been a runaway sales success.

Have you thought of the other product in this general area that had a very notable hiccup?

 

[ActionableMango]

There are two and a half months left in 2018. People are getting worked up way too early. Save your complaints for Jan 1 at which time if Apple hasn't delivered, the complaints will be valid.

 

[Vermifuge]

YTM!!!

Have you thought of the other product in this general area that had a very notable hiccup?

• Group FaceTime
• Open Standard FaceTime

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There are two and a half months left in 2018. People are getting worked up way too early. Save your complaints for Jan 1 at which time if Apple hasn't delivered, the complaints will be valid.

concern, not complaint