toddimt

GeorgeBMac said:

AppleInsider said:

...

Andrew Moore, an emergency department physician at the Oregon Health and Science University, told Quartz Thursday that the Series 4 doesn't rise to the level of a medical device.

"The tech that Apple is working with is very rudimentary compared to what we'd do for someone in a hospital or health care setting," Moore told the site. "The ECG thing is a little bit overhyped in terms of what it will really provide."

Apple has never quite claimed that this Apple Watch, or any other product it makes, is meant to serve as a substitute for full-fledged medical devices or professional medical attention.

It says right there on the Apple Watch, that if the Watch detects atrial fibrillation (AFib), "you should talk to your doctor." At the same time, Apple's Williams admitted that the Series 4 won't always catch AFib every time.

I get the feeling that ai (and most others) don't understand the power of a full 12 lead EKG. 

It reveals far more than an irregular heart rhythm.

That is why a single lead EKG is never used in medical setting:  it just doesn't tell you as much as a 12 lead does.   It's not a matter of increased accuracy either.   A 12 lead provides far more information than a single lead can.

Basically, a single lead EKG (such as a Polar H10 chest strap or an Apple Watch Series 4) can only monitor heart rate.   That's it.   A 12 lead as used in a medical setting provides far more information than that.

Comparing a single lead EKG to a 12 lead EKG is like comparing a pick-up truck to an 18 wheeler.   Yes, they're both trucks and they both carry stuff.  But they aren't equivalent to each other.

I really don't think you understand the point and are conflating things.

First off a single lead ECG is better then the current heart sensor in the iWatch or a Polar heart rate monitor is that it can detect Afib. Can't do that with the current heart rate sensor or the Polar band. 

Second, no one is saying that Apple's single ECG is comparable to a regular ECG. That is not the point. Apple has saved numerous lives with the current Apple Watch, when detecting abnormalities. It has also helps Dr's. diagnose issues in others based on the data it captures. The new iWatch expands on those capabilities by stepping up a notch and incorporating a 1Lead ECG into the device over just a heart rate monitor. Thus, adding a step up in potential detection of issues. The data isn't a diagnosis and no one said it was. Its more data that a user gain gain into their health and maybe potentially alert a user to a "potential" issue.  

Lets put this another way. Are you saying that Apple shouldn't incorporate any additional levels of heart detection unless it incorporates full ECG capability? That would be stupid.  Providing more access to health, if even its a small incremental step is better then no step at all.  I would not 100% rely on the info on its own but sure would report any anomaly to my Dr.  BTW, that same full 10-12 lead ECG machine can't always detect a heart attack either. 

Apple's way of doing things has been to slowly bring the masses around. Over time this will increase more and more and let users be more and more proactive and responsible for their health. The functionality and capabilities will expand through each generation of the watch.  I also wouldn't be surprised if the integrated electrodes and ECG isn't capable of detecting more but still needs FDA approval. For example, AliveCor is currently doing blind testing using their single lead technology with AI to detect potassium deficiency (Kidney issues). Currently, the only way to test is via blood tests.  Thus, it is possible to do things not heard of with AI and single lead ECG. Apple has some of the largest collection of health and sensor data garnered from development of the Apple Watch to users participating in studies with the device. Not to mention hiring some of the foremost experts. So..... 

GeorgeBMac said:

sirlance99 said:

genovelle said:

D4RK31F said:

Apple is not the first to get FDA approval...  I have been using Kardia band (alivecor) for almost half a year now.  What Apple is doing is making it seamlessly integrated into apple watch instead of an accessorized band.

The article says it the first Apple device to get approval, so it is correct. 

I’m finally buying my first Apple Watch and am excited but let’s not misinterprete things. 

No, it’s a clearance. Big difference between clearance and approval. 

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.

I agree with everything you said except for the last bullet.

Polar H7/H10 chest straps (and others) have been taking single lead EkGs for years.  They don't need a complete circuit because they are positioned at the source, on the chest.   The complete circuit, as I understand it, is simply to cross the electrical signal from one wrist, across the chest to the other.   A chest strap is already on the chest and has no need to do that.

Further, and somewhat unrelated:   Obviously a wrist based optical sensor can also monitor heart rate and detect a-fib because Apple has been using their optical sensor to do just that.   The difference between it and the electrical sensor is accuracy.   That was illustrated in a study the Cleveland Clinic did a few years ago where they showed that, at 90% accuracy, the Apple Watch was the most accurate of all consumer grade heart rate monitors.   But, the chest strap (using a single lead EKG) at 99% was the most accurate.

While the Polar is technically a HCG, it is solely for the purposes of obtaining a heart rate. It is not FDA cleared to provide any medical information to a user whatsoever. Thus, it does not detect Afib, low heart rate or provide a ECG.  Just provides a heart rate. 

13485 said:

sirlance99 said:

No, it’s a clearance. Big difference between clearance and approval. 

What the Apple Watch is not

 • 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....

There is no essential difference between "FDA Approval", which is terminology they use for Class III medical devices and drugs (the highest risks) submitted by PMA, and "FDA Cleared", which is the terminology they use for Class II (moderate risks) and Class I (low risk) medical devices submitted by 510(k).  Both mean that the products have received FDA approval to be commercially marketed and have met the risk-appropriate clinical results, design, quality, safety, efficacy, and good manufacturing practices regulations. One is NOT a lesser or incomplete form of approval. FDA no longer prosecutes manufacturers who use the word "approved" in labeling instead of "cleared".

 This