Hands-On With the ECG Feature for Apple Watch Series 4

[newellj]

All Apples Health Kit products are basically "for novelty purpose only" if you fear something wrong get it checked out (but not by us)

Hopefully a little more than mere novelty, but not real diagnostics, either, in my view. My personal take on this all is that it's a useful data collection point that could be of use to physicians in the future. Something that comes up later might get a more accurate diagnosis if you've got long-term data. I could be totally wrong about that, and YMMV.
[doublepost=1544270069][/doublepost]Thanks for the very detailed and thoughtful post. Do you have any theories on why AliveCor has been able to get the Kardia products "approved" (not speaking legally or technically) in so many countries? Is it because this was done under the MDD and other earlier (even if only slightly earlier) medical/regulatory regimes? On the surface, it seems that with Apple's resources they should be able to get the AW4 EKG approved quite broadly and reasonably promptly?

Well... It is not that simple. It is very difficult to compare the "strictness" of FDA and EU legislation.

In this case AW4 has the FDA clearance (not approval) so that it can be marketed in the US. In the EU it seems to fall into MDD (Medical Devices Directive) domain, which then sets another set of requirements. The requirements for MDD compliance might be stricter than those for FDA clearance, but when comparing MDD compliance and FDA approval, the latter is usually more difficult to achieve. Or at least that is what most players on the field think.

This is further complicated by the fact that the EU is right at the moment transitioning from MDD to MDR (Medical Devices Regulation), which is much more comprehensive, and in most cases stricter than MDD.

I know something about MDD, MDR, and FDA in practice, and personal smart devices such as AW4 are far from simple from the regulatory perspective. If you have a simple hardware (and fixed firmware) based medical device, the regulatory situation is straightforward. Just read the regulations and carry out all tests mandated by the regulation. After you have gathered that truckload of paperwork, someone will stamp it, and that's it.

But in AW4 you have a smart device which does a lot more than a medical device. It has some medical-device-related hardware and software running in it, as well as an app running in another device. What exactly is the medical device here? If the complete system (AW4 HW + WatchOS + iOS + app) is the medical device, it will never become MDR compliant. This is just because then all SW and HW in AW4 should comply to the relevant requirements, which is just impossible.

So, the regulators in any country need to decide which part of AW4 (plus the app) is "a medical device". Before that happens, the device will not receive any medical device approvals practically anywhere. The FDA is playing an important role here, and I guess there is a lot of international cooperation going on behind the scenes.

One possibility is to find out other arrangements similar to the FDA clearance. The device itself is not a medical device, but it can be used in personal use. This is probably the best route to take as these devices gain popularity. One trick that has been used is to label devices as "wellbeing" stuff—as has been done with HRM monitors in general. ECG, however, is so deep in the field of medicine that this explanation may not pass any serious scrutiny.

I am afraid the ECG functionality may not be available in the EU any time soon. The EU might still be the second one (or third after China) to get the ECG functionality, as the amount of money spent with specialists, lawyers, and regulatory agencies is approximately constant and independent of the market size.

 

[sos47]

sometimes i hate apple for their strategy - you pay full price for the products but you get not full features if you live in other countries. this AW, ATV, iOS Apple Maps, Apple Pay, and so on.

 

[canyonblue737]

sometimes i hate apple for their strategy - you pay full price for the products but you get not full features if you live in other countries. this AW, ATV, iOS Apple Maps, Apple Pay, and so on.

Their "strategy"? You think Apple wants to prevent the identical hardware in other countries from being able to use the ECG feature? Obviously there are LAWS that Apple has to abide by and getting approval in other countries for health features is a case by case basis with each country being unique. The only thing Apple could have done here is simply avoid putting features in their watch that would be subject to these issues but then no one gets innovative and potentially life altering features. Hopefully the ECG on the watch gets approved in your country soon.

 

[Jervasio]

 

[canyonblue737]

It's great that he brings his experience to this but heads up, this was made long before the release of the actual feature and makes bold guesses of the false positive rate that are just that, wild guesses. The idea that 19 out 20 Afib results from the watch will be a false positive as he suggests in this video seems insanity to me, I can't imagine Apple would release something that was wrong 95% of the time it said you have a health problem and I'd suspect the feature would be pulled from market very quickly if it turns out to be true. Frankly on the basis of this one suggestion alone I don't put a lot of weight in the rest of the video.

Want my own wild and totally uneducated guess? The false positive rate for Afib on the Apple Watch will be stunningly small, like microscopic (although the 1 or 2 cases that happen will likely get big press if they happen) but the way that will be achieved is to be super conservative in diagnosing Afib, ie. the watch won't say you have Afib unless it is really, really, really sure and is actually far more likely to MISS real Afib than tell you that you have Afib when you don't.

 

[Jervasio]

It's great that he brings his experience to this but heads up, this was made long before the release of the actual feature and makes bold guesses of the false positive rate that are just that, wild guesses. The idea that 19 out 20 Afib results from the watch will be a false positive as he suggests in this video seems insanity to me, I can't imagine Apple would release something that was wrong 95% of the time it said you have a health problem and I'd suspect the feature would be pulled from market very quickly if it turns out to be true. Frankly on the basis of this one suggestion alone I don't put a lot of weight in the rest of the video.

Want my own wild and totally uneducated guess? The false positive rate for Afib on the Apple Watch will be stunningly small, like microscopic (although the 1 or 2 cases that happen will likely get big press if they happen) but the way that will be achieved is to be super conservative in diagnosing Afib, ie. the watch won't say you have Afib unless it is really, really, really sure and is actually far more likely to MISS real Afib than tell you that you have Afib when you don't.

"This App is banned in Australia, The Australian Heart Foundation says it's not an approved medical device and would be way to inaccurate and it will not be allowed here."

I live in Europe and tbh I don't trust FDA, I think some things get cleared way too easily. If Apple gets the approval to use it in European Union, then I'll be more confident on this new feature.

 

[mdmitchell]

Healthy people don't do that. They run in the park, eat well and enjoy life without worrying about disease all the time.

Actually, there's evidence that middle-aged endurance athletes are at elevated risk of atrial fibrillation even though all their other heart risks are lower than those of less active people. Nobody has a solid explanation for it yet.

 

[farmboy]

If I may add to your comments, a 510 (k) device isn't simply cleared by FDA because it's similar in design or indications for use to a previously cleared product, rather the company must prove by actual data that it is similar to the predicate device, and that it is manufactured under the regulations of 21 CFR 820 Good Manufacturing Practices.

 

[redman042]

Remember folks, Apple has to start somewhere. Yes, it just measures Afib, and no it's not yet cleared in other countries, but like Apple Pay, it's the start of something bigger and will need time to evolve. Medically-related functions like this don't happen overnight.

 

[Taylor710ce]

Anyone beta testing will need to remove their profile within General, then update again within their iOS.

 

[Kaitain4]

I just went out and bought an Apple watch for this very purpose. (plus I was about due, anyway.) I have occasional (2-3 times a year) heart palpitations and over the years the docs have never been able to capture it to see what was going on. Or to even know how often it happens (I only notice it when I'm in a sedentary posture.) It's difficult to describe the heartbeat pattern to a human, too.

At the very least this will likely let me know how often this occurs, I may not notice it sometimes. Plus if I'm able to capture it in-watch a few times perhaps the admittedly not entirely clinical tape could give a clue on where to look for problems with my ticker.

I'm not under any delusions that this qualifies as a medical device, but broadly it could give me an idea of how prevalent the problem really is, and perhaps the intensity of it at the time it occurs.

It can save your life - even without the ECG feature. My Apple Watch 3 potentially saved me last year. The watch gave me an abnormal heart rate warning while I was at rest. Concerned with that, I had some tests done by my regular provider and they came back negative. Later I was able to convince my provider to send me to a cardiologist, based on the evidence of irregular heart rates coming from my watch. The first test from the cardiologist also came back negative, but I trusted my Apple Watch wasn't lying, so I asked if there was more we could do. He said he could put me on a 30 day heart monitor, which we did. That test showed I had intermittent Ventricular Tachycardia (VT) - an extremely serious and potentially lethal condition. I was given more tests and scheduled for surgery within days. I had a successful Cardiac Ablation procedure, which cured the VT. I fully believe my watch saved my life in this instance.