Apple Watch Series 4's ECG could potentially take years to approve in other countries

27 September 2018
Don't get your hopes up because regulatory agencies require a ton of work before such tech being approved.

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  • Paul

Why does it need to be approved ? It isn't accurate anyway just like the heart BPM which is also just an indication and that wasn't approved neither.

Apple should just activate this with the notion that it is just a best effort indication disclaimer.

it was ready to come in microsoft band 3 already some time before, should not take so much time.

Seriously, people think this ECG gimmicks are real? You never accurately will see your heart cardiogram or whatever with this tiny device, you need a proper equipment for that, I can't believe people blindly believes everything what Apple throws to them

  • artkicz

what dose mean "'available to us customers"" or ""available in us""? if I buy this watch in US it will not work in EU or what? will it check localization in order to work? if not, then simple solution is to buy this watch in US and use in the rest of world

  • jim

won't take that long with enough money

Hmm it's a dubious tech at best. It's not a true ecg because it doesn't measure/monitor cardiac electrical activity. The electrodes need to be where the heart is in order to capture readings of electrical conduction over the anatomic area of heart. The limb leads in the classic ecg (the ones attached to the extremities) measure general vectors in relation to the actual conduction of electrical impulses along heart muscle and specialized conductive tissue.

Long story short, it's bollocks. But as someone pointed out earlier, it can have its uses.

  • Kangal

Bewildered , 28 Sep 2018It must have been known to Apple that even in the U.S.A the... moreWhat?
You clearly don't know what you're talking about.

The USA FDA already approved the Apple Watch v4 before the announcement. Whilst I'm sure there were some corruption and baked cookies going on, and that the ECG function of the watch is probably pretty bad... it still means it is working.

And the common ECG is a 12-Lead connection, with two on the torso, two on the wrists, and then six on the chest/heart. Yes, total that is 10 connection points but it is medically known as a 12-Lead ECG (some electrodes are "pairs").

If I needed an ECG, I would use a tried and true model not an Apple Watch... but that doesn't mean the Apple watch cannot be helpful. There has been a few cases where the Data on the Apple Fitness helped some doctors determine cardiac arrests, and that was on the older models, so clearly it has some uses.

  • Anonymous

Some countries will go for a simplified approach and approve it based on FDAs approval. For example, no trials will be carried out anyway in Thailand, Philippines, Indonesia, etc, so why not approve it based on the findings from the worlds leading authority in such matters, the FDA? It will happen and it can happen on a wide scale.
Its also worth pointing out that EU has in the past approved medicines with no proven effect where FDA has not approved the same medicine, so its hard to see why it wouldnt be approved in the EU, where things are approved based on how expensive hotels in the Swiss Alps the medical companies treat the bureaucrats to.

  • Bewildered

Note7 owner, 27 Sep 2018This is a game changer and has huge implications for the sm... moreIt must have been known to Apple that even in the U.S.A the presentation would not pass certification even by the FDA

As a UK resident , I found it odd that Chief Cardiologist whatever his title was endorsing an untried (non FDA approved) device

ECG require 13 contacts? IDK the exact number but more than the 4 in Apple Watch

It's a bit like a court case where the Judge orders the jury to disregard a statement.

Apple have no intention of to seek regulatory approval

Considering the Apple Watch only lasts 18 hour, and one of the cardiologist statements is that many patients report events and then visit him, having an ECG of an event should be a low priority, calling 911 US or 999 UK is paramount, the pain in your chest is all the indication you need.

This is a game changer and has huge implications for the smartphone market as well. Many people will switch to iOS just to be able to purchase this Apple Watch. But like everything else let Apple do the heavy lifting with regulations and Android vendors swooping in for the carcasses.

It would be exactly the same situation if any other company brought this out. If it benefits people then it's all good

  • Anonymous

Anonymous, 27 Sep 2018Classic apple exactly

  • Anonymous

Classic apple