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Does Apple have any specific date for the ECG?
- Thread starter M.Shaf213
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Not necessarily, pick one, it's going to be as accurate as any other answers you'll get.
Apple is pretty tight-lipped about that. Just like childbirth, it will come when it's ready.. 
A Tuesday, probably.
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Later this year in the US only.
No one knows for sure. Having stuck their neck out with the "this year" promise, I'm sure Apple is doing everything in its power to make that happen. Unfortunately, we have a federal agency involved. And that can lead to delays.
I think it'll happen this year. However, unless its hidden in the code for WatchOS 5.1.2 (possible but I think someone would have sniffed it out by now), it'll either have to be done via another release (5.1.3? 5.2?) with no betas (seems unlikely) or Apple flips a switch somewhere and it becomes active.
I think it'll happen this year. However, unless its hidden in the code for WatchOS 5.1.2 (possible but I think someone would have sniffed it out by now), it'll either have to be done via another release (5.1.3? 5.2?) with no betas (seems unlikely) or Apple flips a switch somewhere and it becomes active.
The functionality is already there embedded in the Digital Crown. I’m sure the code is already in place. All we need is the app.
Apple claimed they already had FDA sign-off during the September event. I haven't looked that up, but presumably you can do so.
I don't know whether it needs to be in or referred to in an iOS update. Possibly it will arrive as a free-standing app.
Having "sign-off" and having the paperwork in place that accompanies that sign off can be 2 very different things.
Apple spokespeople clearly indicated that the regulatory approval in the US was complete.
Did you read the letter? It clearly lays out prerequisite testing and controls which must be in place before the ECG can be put on the market. In the future tense.
A lot of people are anxiously waiting, I suggest all of you write Apple some feedback and let them know how you feel.
https://www.apple.com/feedback/
Alternatively, if you have influence on a social network, post there. If Apple doesn't know that we are all waiting, there isn't very much pressure on them to get this released.
https://www.apple.com/feedback/
Alternatively, if you have influence on a social network, post there. If Apple doesn't know that we are all waiting, there isn't very much pressure on them to get this released.
I suspect Apple is not holding back this feature to just be mean. I suspect they are making sure it is right as so many will depend on it. If it comes next year it will not be the end of the world!
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I did. Did you?
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.
Yes. Marketing does not equal selling. And note the last clause re special controls, which refers to the 5 numbered items. None of those were listed as already having been done. So the logical inference here is that Apple was allowed to talk about the app at the iPhone event (marketing) but cannot deploy it until it met those conditions.
Technically, "marketing" means taking your product to market (to sell), so it could depend on legal definitions.
Product promotion is just a small part of marketing. In general terms, product marketing also includes pricing and selling in addition to promoting a product. Again, it really goes back to the legal definition of "marketing" in this case.
This is sort of interesting and probably needs an IP lawyer to really understand. The FDA letter says that a 510(k) notice is required, and here's the bad news on that for us (bold text). If that's applicable, Apple would have to file that notice 90 days before it actually starts delivering the ECG app. Since no one in the media has publicized such a filing (assuming it's a publicly available filing), that would mean the actual delivery date is some time in mid/late-February at the earliest.
A 510(k) is required when:
- Unless exempt, introducing a device into commercial distribution (marketing) for the first time. After May 28, 1976 (effective date of the Medical Device Amendments to the Act), anyone who wants to sell a device in the U.S. is required to make a 510(k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date. If your device was not marketed by your firm before May 28, 1976, a 510(k) is required.
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