Become a MacRumors Supporter for $50/year with no ads, ability to filter front page stories, and private forums.
I think this is a cool wow feature but mostly useless. I was also disappointed to see they can only recognize normal or atrial fibrillation - Afib can already be identified by the heart rate monitor! I hope with machine learning they can make progress on identifying more abnormal rhythms. Given the power of modern tech the algorithms for identifying rhythms could use some machine learning magic and updating.
The algorithms are smart enough--the problem is that arrythmias don't fit into nice neat categories.
[doublepost=1536854190][/doublepost]
Can anyone answer this, why 22 and older? Does it harm 21 year olds? (Usually 22 and under don’t get afib I get that but surely it’s not much of an issue to use it is it?)
It's regulatory. They would need a separate data set from younger people to submit to FDA in order to get approval to market the device to persons 21 and under (it's legal but "off-label" for a person under 21 to use the feature). Without that approval, the lawyers would want a prominent disclaimer to make clear 'we aren't marketing this device for off-label patient groups.'
[doublepost=1536854288][/doublepost]
Totally agree. The extra we’ll all pay for the EKG we’ll never use probably subsidizes the cost for those who need it.
The hardware probably isn't all that expensive. The costly part is the software and the process of gaining FDA approval. Those one-time costs get spread over millions and millions of watches.
[doublepost=1536854641][/doublepost]
"Should not be used for patients with known arrythmias."
I think this is also a legal dodge. Given my two-year experience with an Alivecor Kardia, this kind of device can be valuable for patients with certain kinds of episodic arrhythmias. It can help characterize the arrhythmia, follow the patient's response to medication or exercise, distinguish side effects from underlying problems, and titrate medication. But since that hasn't been proven to the FDA's satisfaction yet, they have to include the disclaimer in Watch marketing materials.
 
I watched the entire keynotes address & Apple kept that to themselves that the ecg feature would be a USA only feature. I live in the Uk & this one feature was the only reason I was planning upraging from my series 3

That’s once again that we in the Uk have been stiffed from features,where still waiting for Apple Pay cash, now this ecg watch feature. If these features don’t come to Uk then we should not have to pay these high prices.

But that said Apple is an American company so probably that’s why they get the best features first, I don’t know.
 
  • Like
Reactions: Shanghaichica
I guess I can just cross the border and buy the US version of the Apple Watch, since the Canadian version won't have ECG enabled.
ö

I think the ECG hardware will be in every watch. The feature will be disabled in software.
 
Stainless steel has been my choice since the original AW. On this new series 4, I only see GPS+Cellular version for the stainless steel. I don't need a cellular for the AW, so this sucks for me. :(
 
How is watch ECG different from currently available phone apps like Cardiio which measure and record waveform for about 20 seconds by putting finger over the camera? Ectopic heartbeat shows very clearly here when I have it.
I'm not sure about this myself, but Apple watch could do the 'finger over camera' measurement type of thing since day one - and I think do it more precisely, as it had dedicated green LED and receptor for the purpose on its back. I would imagine creating a waveform using this method is really imprecise though.

Stainless steel has been my choice since the original AW. On this new series 4, I only see GPS+Cellular version for the stainless steel. I don't need a cellular for the AW, so this sucks for me. :(
It's been like that with S3 as well. To make things worse for a lot of people, this also meant (and still means) that in many countries, where AW LTE was not supported, they don't even sell the steel models at all.
 
The hardware probably isn't all that expensive. The costly part is the software and the process of gaining FDA approval. Those one-time costs get spread over millions and millions of watches.

I'm reading that the approval process that the Apple Watch went through is more of a clearance, not an actual approval.

https://www.theverge.com/2018/9/13/...es-4-ekg-fda-approved-vs-cleared-meaning-safe

"Second, it’s important to understand that the FDA has “cleared” both apps, but that’s not the same as “approving” them. There are usually three ways to get the FDA involved in a new project, according to Jon Speer, co-founder of Greenlight Guru, a company that makes quality management software for medical device companies. The most advanced is FDA approval, which is done only for Class III products, or technologies that might have higher risk but also a higher benefit. (Think: implantable pacemakers.) Approval is the gold standard, and companies need to do a lot of testing to receive this designation.

The Apple Watch is in Class II. For Class II and Class I, the FDA doesn’t give “approval,” it just gives clearance. Class I and Class II products are lower-risk products — as Speer puts it, a classic Class I example is something like a tongue depressor — and it’s much easier to get clearance than approval."
 
  • Like
Reactions: determined09
Disappointed this is not going to be available in Australia for the foreseeable future. So I will hold on to my S2 until Apple have the ECG functionality approved / released here.
 
https://www.reddit.com/r/apple/comments/9fkb3t/im_an_emergency_physician_and_wanted_to_talk/

I'm an Emergency Physician and read/interpret ECGs on a daily basis. I wanted to talk about the Apple Watch's new ECG feature as there are a lot of misconceptions about this new function. Apple Watch's new ECG feature is pretty neat and a lot of people here are understandably excited about it, but it does have limitations.

I also wanted to do a brief tutorial on the basics of ECGs.



Electrocardiography aka ECG or EKG

At its basic core, ECGs measure voltage activity in the heart. As the heart beats, electrical activity moves along the heart and shows up as the bumps and spikes in the ECG.

Voltages are measured across gradients meaning you need at least two electrodes with vectors go across the heart. An ECG computer measures these voltages and calculates certain vectors or "leads" based on the orientation of the electrodes and displays them as a rhythm strip, that looks something like this.

Some of these vectors are direct measurements of certain electrodes, while others are calculated by the computer across multiple electrodes.



The most comprehensive ECG is known as a 12-lead ECG.

This ECG uses 10 electrodes, 4 on each limb, and 6 in a specific orientation around the heart in order to represent 12 separate vectors across the heart. In some ways you can think about this type of ECG as almost a 3D measurement of electrical activity in the heart.



The heart monitors typically used in the hospital settings usually use 3-5 electrodes, limiting the number of leads that are measured, but still useful for other diagnostic tests as they are typically continuous.



What is Apple Watch's ECG?

The Apple Watch ECG is a single lead ECG, measuring Lead I. This is great for measuring the rate and rhythm of the heart which can be very useful for the screening of atrial fibrillation.

Atrial Fibrillation Rhythm Strips

The normal bottom strip is nice and regular and also includes something called a P-wave that represents the beat of the atrium and is supposed to be before every big spike. The top strip represents afib, the spikes are disorderly and not regular, it is also notably missing that P-wave.

In its current state, the Apple Watch will continuously monitor your heart beat with it's optical sensor, and if it detects an arrhythmia, prompt you with a notification at which point you can conduct an ECG.



Atrial Fibrillation

Atrial Fibrillation (aka a-fib) is the most common cardiac arrhythmia, and up to 25% of people above the age of 40 will experience at least one episode of afib. It occurs when the normal path of electrical activity is interrupted and disorganized.

Atrial fibrillation can occur in episodes that may only last a few minutes and go back to normal rhythm by itself. Some of these episodes can be precipitated by certain events like drinking alcohol, being sick, or other medical conditions. Some people will have recurrent episodes of self resolving afib, also known as paroxymal atrial fibrillation with no known cause. The extreme of this are people who have persistent afib and who's rhythm can be very difficult to flip back back to normal.

Having atrial fibrillation in it of itself is not necessarily an emergency. Many people with atrial fibrillation are completely asymptomatic and others may only have the feeling of palpitations or an irregular heart beat.

Where atrial fibrillation can get dangerous is if it causes vital sign abnormalities, where your blood pressure can get so low you pass out, you feel short or breath, or your heart rate is dangerously fast. If your heart rate is greater than 100-110 or so, you are in a state called atrial fibrillation with rapid ventricular response. At this point we would control your heart rate with IV medications in an emergent setting.

While brief periods of asymptomatic afib can be benign, sustained atrial fibrillation increases your risk for stroke, clots in the lung, and heart failure. Depending on the patient's risk factors, some people will require blood thinners to reduce these risks. The longer your heart is in uncontrolled afib, the more difficult it is to reverse as there can be an element of cardiac remodeling.



What the Apple Watch is not

At this point in time, the Apple Watch ECG feature is not indicated for the detection of any heart conditions except Atrial Fibrillation.
It is also not indicated for people who already have a diagnosis of atrial fibrillation, who should be seeing a physician regularly.
It is NOT capable of ruling in or out a heart attack. Even a full 12-lead ECG can miss certain heart attacks.
It is also NOT considered an FDA approved medical device as some people have claimed it to be. The FDA simply released clearance letters, also known as a 510k Pre Market notification clearance, that also explicitly state that it is not intended for people under the age of 22. It is considered as an over-the-counter (OTC) device and classified as Class II, which is the same class as things like condoms and home-pregnancy kits.
It is also not a continuous monitor of your heart's electrical activity. It is only capable of measuring an ECG while your other hand is on the crown.
A single electrode ECG is also physically impossible. In order to measure electrical activity, there needs to be a complete circuit that passes through the heart. Not even a wireless device on the other hand can get around this as it wouldn't be part of the same electrical circuit.



TLDR;

In summary, the new Apple Watch looks like a great tool, but it is not meant to be a medical grade device and not a substitute for medical and professional evaluation in the case of symptoms. Even if your Apple Watch ECG appears totally normal that does not necessarily mean you do not have atrial fibrillation or other cardiac abnormalities.

Sources:

https://lifeinthefastlane.com/ccc/atrial-fibrillation/

https://en.wikipedia.org/wiki/Electrocardiography
 
Well according to the Apple website in the UK the watch has the following:-

  • Optical heart sensor
  • Electrical heart sensor
So does that mean the ECG function will be working in the UK??
 
You describe a screening tool. I’m still searching for technical literature on its screening characteristics. I disagree that the readings are not intended to be “used” by doctors. Patient comes in to report that their watch told them something. Doctors would want to know precisely what the patient was seeing, what the watch told them. Not “my watch found something unusual”.
Disagree. Doctors would usually ignore the watch readings and would run the necessary tests anyway with proper and professional medical devices. Cant really see any problem with this. The ECG as well as the heart rate monitor are just alarms for you only. The fact that some doctor can use such alarm as an excuse to run you some medical tests is completely irrelevant.
 
Disagree. Doctors would usually ignore the watch readings and would run the necessary tests anyway with proper and professional medical devices. Cant really see any problem with this. The ECG as well as the heart rate monitor are just alarms for you only. The fact that some doctor can use such alarm as an excuse to run you some medical tests is completely irrelevant.
I agree that doctors would proceed with usual workups based on usual indications and on this we certainly agree. But the headlines suggest that the function identifies possible afib, and that’s what I was responding to.
 
Where atrial fibrillation can get dangerous is if it causes vital sign abnormalities, where your blood pressure can get so low you pass out, you feel short or breath, or your heart rate is dangerously fast. If your heart rate is greater than 100-110 or so, you are in a state called atrial fibrillation with rapid ventricular response. At this point we would control your heart rate with IV medications in an emergent setting.
Good stuff mi7chy!

Atrial fibrillation should not be confused with ventricular fibrillation (which is the condition that automated external defibrillators--AEDs--are meant to treat).

The big threat from atrial fibrillation is stroke. Because the heart chambers are not working in sync, blood can pool in the heart instead of being pumped right out. If a clot forms there, it can travel up to the arteries supplying the brain and cause a stroke.

This is why someone who has AF that doesn't resolve right away should seek medical attention immediately.
 
Yeah, not sure why Apple thought they could claim having "the first over the counter ECG", when they're not even close to being first. Especially with Alivecor having gotten FDA approval for their Apple Watch related device last year:

https://www.macrumors.com/2017/11/30/alivecor-kardia-ekg-band-medical-fda-apple-watch/

As someone else noted, you can also buy such devices off Amazon in the UK and EU.

The Apple COO probably forgot to include some qualifying phrase in his speech.

It looks like the FDA clearance for this is only to detect AFib, whereas Apple fit clearance for a lead 1 EKG. I could be wrong.
 
Another feature thats for the US only. America first.

I bet we (EU) will not see this for a long time, and it's not unlikely that maybe when series 5 is released we get it (if ever). In the mean time Apple hopes we all jump on the band wagon for features that are (release wise) totally unclear / un certain.

After-all. Still no:
  • Apple Pay
  • Apple watch 4G
  • Rental TV shows
  • Cut cable with TV
  • Spotlight smart search (cant even asked the freaking weather!)
  • iOS Nearby (maps)
  • News App
  • etc.

I love Apple, but this false form of advertisement(-isch) (announcing on a WW keynote) should be forbidden. Time for a EC (European Commission) to step in and say something about this. It's ridiculous. In the mean time we pay same price.
 
Another feature thats for the US only. America first.

I bet we (EU) will not see this for a long time, and it's not unlikely that maybe when series 5 is released we get it (if ever). In the mean time Apple hopes we all jump on the band wagon for features that are (release wise) totally unclear / un certain.

After-all. Still no:
  • Apple Pay
  • Apple watch 4G
  • Rental TV shows
  • Cut cable with TV
  • Spotlight smart search (cant even asked the freaking weather!)
  • iOS Nearby (maps)
  • News App
  • etc.

I love Apple, but this false form of advertisement(-isch) (announcing on a WW keynote) should be forbidden. Time for a EC (European Commission) to step in and say something about this. It's ridiculous. In the mean time we pay same price.
Don’t think we will get the ECG for a long time in the UK but to be fair all the the things you mentioned in your list we have in the UK.
 
Don’t think we will get the ECG for a long time in the UK but to be fair all the the things you mentioned in your list we have in the UK.

Have a look at the rest of Europe. There are huge difference in services provided, most are simply absent. Except UK, DE, FR. Problem is there are are another 25+ countries in EU
 



Apple Watch Series 4 models include an electrical heart rate sensor that's designed to take an electrocardiogram (ECG) using an ECG app, the built-in sensor, and the electrodes included in the Digital Crown, but the ECG functionality won't be coming until later this year.

According to Apple's Apple Watch Series 4 website, the ECG app that will enable the electrocardiogram feature will be available later in 2018. That means at launch, the ECG feature won't be functional.

applewatchecgfeature-800x419.jpg

As several MacRumors readers have pointed out, it appears ECG readings are going to be limited to Apple Watch models sold in the United States. Apple Watch Series 4 pages for countries like the UK and Canada contain no mention of the feature, and Apple's press release for Series 4 models says ECG functionality is U.S. only.

To take an ECG reading from the Apple Watch, users will need to place a finger on the Digital Crown while wearing the watch. The reading is completed in just 30 seconds, allowing users to determine whether their hearts are beating in a regular pattern or if there are signs of atrial fibrillation, which can be an indicator of serious health problems.

Atrial fibrillation is a health condition that often goes undiagnosed, so the ECG feature in the Apple Watch will be highly useful for detecting early signs of disease. ECG readings also normally require a full ECG machine and a visit to the doctor, which is far less convenient than a reading taken with the Apple Watch.

Apple says that the ECG feature in the Apple Watch has been granted a De Novo classification by the FDA as outlined on the FDA's website [PDF], and the need for regulatory approval is likely why the ECG feature is not available in other countries.

De Novo FDA approval is a preliminary approval process granted to new devices that are not likely to cause harm. According to the FDA, the Apple Watch's ECG feature should be used only for informational purposes, should only be used by those over 22 years of age, and is not recommended for people with known arrhythmias.Apple has also obtained FDA approval for the feature in the Apple Watch Series 4 models that sends notifications when an irregular heart rhythm is detected through the ECG feature or through standard Apple Watch heart rate monitoring.

All ECG data gathered by Apple Watch Series 4 models is stored in the Health app in a PDF format that can easily be shared with physicians.

Article Link: Electrocardiogram Functionality in New Apple Watch Series 4 Models Limited to US, Coming Later This Year
[doublepost=1540770642][/doublepost]With all of the grousing about ECG, I’m 5 weeks out from quadruple cardiac bypass — ECG is GREAT FUNCTIONALITY not only for those of us with bad genes but also for others. Grousers, quit being so selfish.
 
  • Like
Reactions: rugmankc
[doublepost=1540770642][/doublepost]With all of the grousing about ECG, I’m 5 weeks out from quadruple cardiac bypass — ECG is GREAT FUNCTIONALITY not only for those of us with bad genes but also for others. Grousers, quit being so selfish.

Been under the knife a few times myself---good luck on your surgery--:)
 
Register on MacRumors! This sidebar will go away, and you'll see fewer ads.