ECG Feature on Apple Watch Could Take Years to Be Approved in the United Kingdom

[coolkid93]

Thankfully I’m not in the UK, sucks for you all lol



IPhone 8 Plus (256gb)
Apple Watch series 2 42mm (sport)
Apple Watch series 4 44mm
iPad Pro 9.7” LTE 128gb
MacBook Pro mid 2014 16gb Ram 256gb ssd
MacBook Pro mid 2012 8gb Ram 1tb ssd

 

[StyxMaker]

"Hold your finger on the crown."

Is this really something UK citizens do?

Since the parliament, in the17th century, deposed Charles I, chopped off his head, and gave the crown to his son, the citizens have been holding a finger, or a thumb, on the crown.

 

[farmboy]

They didn’t get FDA approval....they got FDA clearance. Totally different matter altogether.

Sorry, you, and the author of this article, are wrong in perpetuating this myth that “clearance” is some lesser form of FDA approval to sell a device. The words are strictly associated with the risk classification type of the device and the type of submission, not some quality of approval. Class I and II devices will be cleared, Class III devices will be approved.

Stop it.

 

[GoSh4rks]

When it comes to medical devices - the regulations are there for a reason - to stop ineffective or quite frankly BS devices being sold. I.e. if you're going to sell a medical device, you need to be able to back up your claims with a clinical study.

I honestly don't believe Apple didn't realise this/know the timelines involved. I'm assuming that either:

a) They're already going for an EU-wide license, so aren't bothered about the UK specifically (which will, of course, still be valid post-brexit); or

b) They're basically using this as a US trial - in order to gauge how well it works and get reactions, before rolling it out to other nations which have stricter checks.

Other reports seem to suggest option A - http://www.idownloadblog.com/2018/09/24/apple-watch-series-4-ecg-app-europe/

CE mark will cover EU and UK.

I think the USA FDA Clearance is harder than Europe, Canada and Australia. Qardio has been trying to get the ECG/EKG monitor approved for years in the USA. Their QardioCore is available in Canada, Europe and Australia. It's even available on Amazon in the UK. For some reason it's been held up in the USA.
I've been thinking about ordering on Ebay.

It is. CE mark is typically much easier than FDA.

It's not a gimmick, it's about classification.

The United States has several classes (based on risk) for medical devices. A tongue depressor is a Class I medical device. As is dental floss. The Apple Watch Series 4 will be a Class 2 medical device, in the same category as condoms and pregnancy testing kits. Both condoms and testing kits have good levels of reliability, but no one expects them to be 100% effective, or take the place of more complicated technology or procedures. Same with the Apple Watch Series 4.

You're understating Class II devices. Real hospital grade ECGs are also Class II. So are diagnostic catheters that go into your heart and map arrhythmias for ablation.https://www.fda.gov/MedicalDevices/ucm073942.htm

US and European regulators test medical devices very differently - in US they are basically allowed unless they are obviously harmful, while in Europe they are only allowed if they are proven to be safe.

Nope, this is completely wrong. EU/CE mark is typically much easier. US FDA requires that device manufacturers prove safety and efficacy.

https://www.fda.gov/medicaldevices/...yourdevice/premarketsubmissions/ucm462775.htm

In the United States, Apple has obtained de novo FDA clearance for the ECG feature in the Apple Watch Series 4 and the feature that can send a notification if an abnormal heart rate has been detected. However, FDA clearance is not the same as FDA approval and the FDA does not recommend that the ECG feature be used by those under 22 or those who have already been diagnosed with atrial fibrillation.

The FDA warns that Apple's ECG app is not designed to replace traditional methods of diagnosis or treatment and is intended for informational use only. The Series 4 is the first ECG product being offered over the counter directly to consumers.

None of this has anything to do with it not being approved. No traditional ECGs are approved as they are all considered class II devices.

It is not recommended because Apple didn't prove that, in those patient groups, that they were safe and effective.

I'm a medical device R&D manager.

 

[5232152]

Medicines and Healthcare products Regulatory Agency just want their palms greased. Europe is famous for waisting time via regulations. Nothing like log jamming a digital watch feature.

You mean not letting a company add locally regulated medicinal hardware. Yeah, howndare they test it and not trust Apple blindly.

Sheesh...

 

[jeremiah256]

You're understating Class II devices. Real hospital grade ECGs are also Class II. So are diagnostic catheters that go into your heart and map arrhythmias for ablation.https://www.fda.gov/MedicalDevices/ucm073942.htm

I'm a medical device R&D manager.

Not my intention to understate Class II devices. If you read my post in context to the person describing the Apple Watch as a 'gimmick', I was letting them know that FDA cleared and approved medical device can cover a large range of products, including items s/he might not consider.

 

[WatchFromAfar]

Medicines and Healthcare products Regulatory Agency just want their palms greased. Europe is famous for waisting time via regulations. Nothing like log jamming a digital watch feature.

Nonsense, I'm from Britain and the NHS doesn't want people running to A&E because their watch said so (BTW who's greasing a palm here?)

 

[PhilMacbook]

Except this isn't the EU, its the UK they were talking about. Even if they could sidestep the UK regulations by getting in cleared by the EU, that type approval would probably be null and void when the UK leave the EU next march.

Any word on when/if EU approval might come (specifically Germany)?

I don't think that is correct. The government has said many EU laws will be kept as a way to expedite Brexit. You can't rip up 40 years of law that quickly and in many cases nobody would want to. Over time British law will diverge from EU law but perhaps not in a big way and probably not much with tech.

I am looking forward to leaving the EU and I don't think Apple Watch would be affected if the EU had approved it before then.

 

[ani4ani]

Nonsense, I'm from Britain and the NHS doesn't want people running to A&E because their watch said so (BTW who's greasing a palm here?)

I wonder if in the US, all those false positives (folks thinking they have something wrong that haven’t) result in unnecessary insurance / treatment fees or increased insurance costs?

 

[vintagekeys]

Ah, the good old UK.

I'm surprised they didn't make Apple put a warning label on the box that says that you might choke if you swallow your Watch.

I am sure that would only be needed for Americans.

PS i am not a brit but been more than amazed by the sheer simpleness of the average american.
[doublepost=1538122729][/doublepost]

Any ideas when the ecg feature will make it to Asia (specifically Hong Kong)?

No, cus it wont get approved here.
[doublepost=1538122939][/doublepost]I dont live in the UK/Europe but cannot help to feel a bit pissed of with Apple.
They are clearly only focusing on the USA market.

But at the same time making all their products for a dollar and a dime in China and other asian countries, max their profits, and basically come with some features they hardly do anything to get approved outside of the USA.

This new feature won`t be approved for many countries for a long long time, and Apple now just going to pretend the blame game lies with those other countries to get it approved.

A bit lame for a company relying so much on all the resources from asia but not doing much back (i live in Hong Kong) And i cannot help that this at times feels like typical American way of doing business, only caring themselves but they dont mind if you buy their products, you just don`t get the advertised features as the selling points because its your country who did not approve it....

At least sell then 2 versions one with EKG and one without which is cheaper for all countries outside of the US.

The matter is that this is a big selling feature of the AW4, but not for any other country out of the USA, and for a global company selling international, using Asian countries to produce and other countries to abuse the tax evasion methods, i think they are a pretty selfish American company.

I love apple, but i feel i need to express some frustration with them at times.

 

[Ifti]

Appreciate such features need approval, but why not say in the keynote the watch can do this PENDING APPROVAL.
Apple seems to go head first into an important feature, but fail to mention that half the worlds population (if not more) wont be able to use it in the first instance!

 

[vintagekeys]

Firstly i am not British, i live in Hong Kong.

I feel a bit of a bad taste from Apple that this feature is not release outside of the USA because of the following.

Apple is a global company, for a dollar and a dime producing their products in asia.
Apple is using low tax countries outside of the USA to warrant and maximize their profits.

But in the end in this case as a sample when it comes down to a massively advertised feature of a new product aka EKG they are going to play the victim and play the blame game that other countries/ nations do not approve the use of EKG yet..

They should have give the rest of the world a none EKG AW4 Option or at least give a rebate.
(If they do this, this entire thread is un-nesessery, but as it stance the entire world is paying for a feature only people in America may use as it stance till it has been approved. And for the rest of the world there is no ETA for that as it is per country, it make take a month/year/ never happen.

Perhaps Apple should have just not shouted this feature of the roof but just enabled it per country when it was approved instead. and then updated said country. But as it stance now i feel like they only submitted the requests to other countries very recently perhaps very close to the release of the AW4.

Now do not get me wrong, i know EKG is more like a nice to have feature and not as accurate as doing at a doctor, but since this device is becoming more and more of a health monitor device, what`s next? when the AW5 comes out will more and more features be locked down to the USA only?

A apple product refreshes each year, so if each year new medical features comes out all other countries will be waiting for 1/2/3 years before those medical features are being approved. That is the issue of those countries being slow yes, i totally agree. But why not have this globally arranged prior releasing a global product from a global company.

If they always keep favoring America, surely at some point the rest of the world will move to local/ other companies. This is not a flame intended thread and yes my english is not great, i am sorry if some of my words did not translate very well or too harsh sounding. Accept my appologies in advance.

My bottomline: From my point of view, Apple has no quarrels using other countries to realize their products and maximize their profits and sell their products to their countries but at the same time prioritize America, when it comes down to medical related items.

I am worried for the future of the AW outside of America, as more and more features may be placed on hold or never be realized due other countries regulations. will the AW be a good product over the next few years for other countries?

The Apple Watch is a healthy lifestyle related device and will be further developed into that direction. How do you think Apple should have handled it? are you happy how they are handling it now? i think this only will really affect none american citizen so we will get a two fold awnsers here.

It is not the EKG function by itself that concerns me but the further development and direction we going in with future AW watches and new health related features we will get.

[doublepost=1538124666][/doublepost]*side note, did apple release any statement for which countries they are currently working out the paper work etc to get EKG approved? i feel communication is kept vague about this by Apple. Unless i missed something like a list of all countries currently pending approval.

 

[leebroath]

Yes but they pulled out some doctor at the keynote just to give his take on things and try to sway anyone watching from the FDA I presume, just to move the approval quicker

Wonder how much he got paid ....

Ok so it’s still pending approval and may still not release in 2018

...I can see this being another AirPower Mat scenario haha

 

[trollied]

The news stories that have stated this are pure speculation though. For all we know, Apple may have initiated all of the required processes many moons ago - there aren't any actual facts stating otherwise in the news articles.

 

[vintagekeys]

The news stories that have stated this are pure speculation though. For all we know, Apple may have initiated all of the required processes many moons ago - there aren't any actual facts stating otherwise in the news articles.

But surely by now at least some countries globally not as strict as the UK/ Europe should be able to be listed out to be approved like the US? or none of the other countries in the world have it approved yet? sounds strange to me, but plausible. i am open minded.

But since from the start Apple only advertises this to go live in the USA first, i feel like none of the other countries in the world is actually giving approval yet, and i hardly believe all countries in the world outside of the USA are a lot more difficult with the approval process.

So did Apple actually submitted their requests to most countries they are selling their products to?
I find it so hard to believe that the USA is the only country that have it approved so far, and none of the other countries.

That country launch list could be bigger for sure, some middle east countries or african countries or even colonies/islands of the USA like hawaii? with less strict medical rules etc? but only the USA?

(is hawaii actually aready included as the USA roll-out?)

 

[Steve121178]

It takes ages to get anything done in my damn country.

Funnily enough, if you owe the inland revenue money they seem to be able to chase that up & investigate with an army of people.

 

[Shiro_Simba]

Yes but they pulled out some doctor at the keynote just to give his take on things and try to sway anyone watching from the FDA I presume, just to move the approval quicker

Wonder how much he got paid ....

Ok so it’s still pending approval and may still not release in 2018

...I can see this being another AirPower Mat scenario haha

did he have a white lab coat on? Cause if he did, done deal

 

[vintagekeys]

Please all do understand i am not bitter about not getting EKG from the get go, (if it ever gets approved in HK)

But the fact that we will see this most likely with more health related monitoring features going forward with new AW releases. the fact we paying for something that may never be approved outside of the USA, features that might have been designed from the get go by apple with in the back of the mind it WILL be approved in the USA but no guarantee it will actually be for other countries as well.

My worries what apple might do:
Basically making a product for the American Market specific, that can get approved locally then and if it gets approved anywhere in the world else its a nice bonus for said people.

That is not the direction i want to see apple going into further, as that would stray me a way over time to keep purchasing their AW devices, as it become so localized to the American market and approval processes, that the product overtime with newer iterations may not be usefully for my country anymore. (unless approved but no ETAs and guarantees, you taking a bit of a gamble if you buy into a new advertised feature in that case)

Apple does not guarantee these new features will actually ever be usable in other countries.
It might be approved in a few weeks/ months/ years or perhaps NEVER.

The more of such features going to latch on to the AW in the future the more change is you will have a half working device in your country but are still deemed to pay full price as per the American market.

 

[caspergirl]

The news stories that have stated this are pure speculation though. For all we know, Apple may have initiated all of the required processes many moons ago - there aren't any actual facts stating otherwise in the news articles.

Plus, UK is still member of the European Union. They can still manage to take approval in another country and use it perfectly in the UK for now. As I wrote in another topic

“I was looking earlier for something unconnected with Apple Watch and I spotted one interesting academic paper here https://www.sciencedirect.com/science/article/pii/S2452302X16300638

Among others, this paper mentions the following interesting thing (page 4-5):

“In the EU, every marketed medical device must carry a Conformité Européenne (CE) mark indicating that it conforms to relevant directives set forth in the EC Medical Device Directives of the EU. A device with a CE mark can be marketed in any EU member state. Medical devices that are non-implantable and considered low risk are “self-marked,” meaning that the manufacturer itself simply certifies compliance and applies a CE mark (30). High-risk devices must undergo a more extensive outside review.“

Of course the article continues with the case of high risk medical device approvals but I don’t think that Apple Watch is in this category. What I think is the key is the phrase “Medical devices that are non-implantable and considered low risk are “self-marked,”” meaning I guess that we will be able to use fully the new Apple Watch in Europe.”

 

[jonstatt1]

We don’t have any idea how far along Apple is with other countries. They knew that the effort to pass regulations would have to be repeated outside the US so I am fairly confident that this process is well underway in major markets already.

As already mentioned if the Qardiocore is available in the UK then the watch can’t be that hard.

This media story is sensationalism to cause a reaction based on no true understanding of what regulatory approval is actually needed and where Apple is with it.

That being said, if Apple have messed up with this then they will have a very hard time justifying having advertised this feature on the UK specific Apple website. I wonder if they haven’t featured it on some country websites.

 

[mypins]

Sorry, you, and the author of this article, are wrong in perpetuating this myth that “clearance” is some lesser form of FDA approval to sell a device. The words are strictly associated with the risk classification type of the device and the type of submission, not some quality of approval. Class I and II devices will be cleared, Class III devices will be approved.

Stop it.

Agreed. They submitted a 510k application and received clearance as being substantially equivalent to at least one other similar medial device that was previously cleared or approved by FDA. The statement in the article is incorrect.

 

[splatt]

Have they said anything other than "later this year" about when it will be available in the USA?

I bought it mainly for this feature, without reading the fine print, so bummed to find out it's not ready yet.

 

[Scubaman]

A

Wait, so you can't even activate it in the UK for your own purposes? What about if you buy one in the US and then bring it over?

And another question: if a US citizen brings their series 4 watch over here (UK or EU) does it automatically stop working?

 

[chucker23n1]

A

And another question: if a US citizen brings their series 4 watch over here (UK or EU) does it automatically stop working?

No. It’s tied to your account.

 

[Tech198]

That's not surprising in UK... Apple Pay is having trouble elsewhere as well. The two go together like lime & a coconut.