Apple Heart Study data reportedly used to win FDA approval for Apple Watch ECG

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Comments

  • Reply 21 of 40
    It's a 1 lead system which provides limited data but some data is better than no data, especially if the patient takes a reading when they feel 'unwell'.  A proper ECG is taken using a 12 lead system which uses 10 electrodes attached to the body, these are normally left recording data for a period of hours depending on the reason the physician is carrying out a recording.

    It would also appear that the ECG feature is coming in the 12.1 and 5.1 iOS and WatchOS releases.
    GeorgeBMacjbdragonwatto_cobra
  • Reply 22 of 40
    So they are the first to get a full personal device approved then?  Which is what they said.  The Alivecor Kardia band and their Kardia mobile sensor require a bluetooth connected device running their application to take the readings.  Apple are also NOT charging a monthly fee to use the ECG functionality like AliveCor do.  For the $199 for the band plus $99 per year you are now better off buying a Series 4.
    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.
    edited September 14 jbdragonwatto_cobra
  • Reply 23 of 40
    SoliSoli Posts: 8,367member
    irnchriz said:
    So they are the first to get a full personal device approved then?  Which is what they said.  The Alivecor Kardia band and their Kardia mobile sensor require a bluetooth connected device running their application to take the readings.  Apple are also NOT charging a monthly fee to use the ECG functionality like AliveCor do.  For the $199 for the band plus $99 per year you are now better off buying a Series 4.
    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.
    $200 for AliveCor's Apple Watch band. I imagine this is going to hurt their business.

    irnchrizwatto_cobra
  • Reply 24 of 40
    ...

    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.

  • Reply 25 of 40
    genovelle said:
    I think an important part that people are overlooking is that if I have a Series 4 AND feel/am notified that something is off I can’t take an ECG and save the data which I can then share with my doctor (hopefully). The president of the AHA mentioned he typically has patients report symptoms that aren’t present during an appointment. 

    With Series 4 we can at least get some sort of data, even if rudimentary, for our doctor to start from. This seems like a great capability in a device I’m already wearing every day for reasons unrelated to taking an ECG. 
    Sounds like they went looking for a doctor to down play the significance of this ability. Lol

    No, the doctor is correct.   A full 12 lead EKG provides far more information than a single lead EKG (like an Apple Watch can).   That's why medical facilities add an additional 11 leads when they do one.   It's not just to give the tech something to do.
  • Reply 26 of 40
    asciiascii Posts: 5,926member
    Well there you go. You thought you were doing the right thing and contributing to the academic knowledge of the human race, but really you were just helping Giant Megacorp Inc. to sell their next product.
  • Reply 27 of 40
    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.
    mike1watto_cobra
  • Reply 28 of 40
    genovelle said:
    I think an important part that people are overlooking is that if I have a Series 4 AND feel/am notified that something is off I can’t take an ECG and save the data which I can then share with my doctor (hopefully). The president of the AHA mentioned he typically has patients report symptoms that aren’t present during an appointment. 

    With Series 4 we can at least get some sort of data, even if rudimentary, for our doctor to start from. This seems like a great capability in a device I’m already wearing every day for reasons unrelated to taking an ECG. 
    Sounds like they went looking for a doctor to down play the significance of this ability. Lol

    It’s to keep people in check about the reality of what it really is. It only reads a single lead when you need multiple to have a overall better understanding of what is going on. 
    It uses two electrodes — one on the backside of the watch, worn (say) on your left hand, and the second on the crown, touching your right hand. Thus the circuit. 
    In the case of the Apple Watch, the 2 electrodes comprise a single EKG lead, not 2.   It is to get the signal going across the source of the signal at the chest.
  • Reply 29 of 40
    Did Apple Watch 4 achieve FDA approval via the 510(k) or PMA path? Criteria for medical equipment (devices) in America are amongst the least stringent in the developed world. Commercial pressures and lobbyists work hard "persuading" Senators to refrain from changing the anachronistic and downright hazardous benchmark proofing of new devices. I doubt Apple Watch 4 will ever damage a wearer though I wouldn't be at all surprised if AW4 gave false positives and negatives; forcing people to A&E Depts. or lulling them in to a false sense of security (which could kill). Just how accurate is a AW4 ECG/EKG result compared to a 12-lead ECG/EKG measurement?
    The difference between a single lead EKG from an Apple Watch and a 12 lead medical grade EKG is (far) less in terms of accuracy and mostly from the  additional information the physician can glean from a 12 lead over a single lead.   That's why hospitals use the 12 lead device. 
    edited September 14
  • Reply 30 of 40
    SoliSoli Posts: 8,367member
    ...

    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.  
    Everyone seems to understand.. except for you. How or why you're under the impression that anyone believes all ECG monitors are the same is what you should be trying to figure out. What part of "single-lead" is confusing to you? They clearly mentioned it during a marketing presentation so you can't say they buried that info. I can't even fathom why you think this is a problem. Do you think anyone is expecting you to walk into a top rate hospital just to have an Apple Watch put on your wrist so they can do a single-lead ECG test? How would that even make sense?

    It reveals far more than an irregular heart rhythm.
    It's been made very clear exactly what this can detect.

    That is why a single lead EKG is never used in medical setting
    Is that now tripling or quadrupling down on your previous false claim that has been debunked?

    That's why hospitals use the 12 lead device.
    All hospitals are "medical settings" but not all "medical settings" are hospitals.

    edited September 14 randominternetpersonwatto_cobra
  • Reply 31 of 40
    mike1mike1 Posts: 1,746member
    Seriously, fuck the FDA. Tens of thousands of people die each year because the FDA keeps good safe medical devices and cures off the market or makes it so expensive to get approval they are never even invented. They are not based in science they are a shakedown racket.

    I really think those downplaying the significance of this are reprehensible.  Since doctors are hard to access and will blow you off if you don’t have clear symptoms, having always present medical monitoring is one of the few things that’s actually improving in health care.
    Simply not true. The process of ensuring equipment is safe, effective, reliable and repeatable is slow. You simply cannot do proper studies quickly. They take time. If not, every crack device or medicine would be flooding the market giving false hope to patients. There are exceptions made for experimental drugs for serious conditions whee the possible life-saving benefit outweighs the risks. Of course, they're expensive because so few people would need them.
    Soliwatto_cobra
  • Reply 32 of 40
    Soli 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.  
    Everyone seems to understand.. except for you. How or why you're under the impression that anyone believes all ECG monitors are the same is what you should be trying to figure out. What part of "single-lead" is confusing to you? They clearly mentioned it during a marketing presentation so you can't say they buried that info. I can't even fathom why you think this is a problem. Do you think anyone is expecting you to walk into a top rate hospital just to have an Apple Watch put on your wrist so they can do a single-lead ECG test? How would that even make sense?

    It reveals far more than an irregular heart rhythm.
    It's been made very clear exactly what this can detect.

    That is why a single lead EKG is never used in medical setting
    Is that now tripling or quadrupling down on your previous false claim that has been debunked?

    That's why hospitals use the 12 lead device.
    All hospitals are "medical settings" but not all "medical settings" are hospitals.

    You have no idea what you're talking about.   instead you're just making up nonsense.

    Go troll somebody else fool!
  • Reply 33 of 40
    Let the healthcare equipment breakthroughs continue:

    https://www.sciencedaily.com/releases/2018/09/180911110232.htm
    watto_cobra
  • Reply 34 of 40
    ...

    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..... 

    Solijbdragonwatto_cobra
  • Reply 35 of 40

    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. 
    Soliwatto_cobra
  • Reply 36 of 40

    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".


    jbdragonwatto_cobra
  • Reply 37 of 40
    13485 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
    watto_cobra
  • Reply 38 of 40
    toddimt 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..... 

    No, I am not saying any of that....
    What I am saying is:   During their presentation Apple called it an "EKG" and many here assumed that they meant "an EKG".   But for decades an "EKG" has meant a 12 lead EKG performed in a medical facility that provides a wealth of data to the cardiologist.   While, on rare occasions they might use less than 12 leads, it was then qualified as say, a "6 lead".    Further, in a medical setting there is essentially no such thing as a single lead because all it can do is measure heart rate.  It is incapable of providing the data a cardiologist needs when he orders an EKG.

    I think many people have assumed that an EKG only measure heart rate and its associated rhythm.   But a normal 12 lead EKG provides FAR more information than that.

    So, while technically a single lead EKG is still an EKG, it is misleading and has misled multiple people since the keynote to believe that the Apple Watch can provide the same or nearly the same information as a 12 lead EKG performed by a technician in a hospital setting.   Thankfully, it is slowly coming out that the two are quite different. 

    So I am only talking terminology.  That's all.   Nothing more.
    I am not denigrating Apple or the Apple Watch or its heart rate sensor or its single lead EKG in any way.  As usual, they marvels of engineering and fully functional and useful.   Apple doesn't do it any other way.
  • Reply 39 of 40
    SoliSoli Posts: 8,367member
    toddimt 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..... 

    During their presentation Apple called it an "EKG" and many here assumed that they meant "an EKG".

    I think many people have assumed that an EKG only measure heart rate and its associated rhythm.   But a normal 12 lead EKG provides FAR more information than that.

    So, while technically a single lead EKG is still an EKG, it is misleading and has misled multiple people since the keynote to believe that the Apple Watch can provide the same or nearly the same information as a 12 lead EKG performed by a technician in a hospital setting.
    1) It is an electrocardiogram, and for you to say it's not "an EKG" and the contradict yourself in the same post by saying "technically a single lead EKG is still an EKG" is pretty crazy.

    2) Apple was very clear in their presentation, not just in fine print, to mention it's a single-lead. On top of that they specifically stated EXACTLY what it can be used for…. which is—coincidently¡—the 
    exact same thing as the countless other single-lead EKGs can be used for so why the hell are you shocked by this?

    Further, in a medical setting there is essentially no such thing as a single lead because all it can do is measure heart rate. 
    Again with your "there's no such thing a a single lead" bullshit. :eyeroll:

    It is incapable of providing the data a cardiologist needs when he orders an EKG.
    What's that? A cardiologist would want a more comprehensive test, you say? How crazy is that, that a specialist in a field would want to do in-depth testing for their speciality? What are the chances of that?¡

     Thankfully, it is slowly coming out that the two are quite different.
    You're the only one that seems confused by what Apple clearly stated and demoed on Wednesday.

    I am not denigrating Apple or the Apple Watch or its heart rate sensor or its single lead EKG in any way.
    Yes you are. You keep saying Apple misled the audience by making it seem like a 12-lead monitor when they were crystal-fucking-clear about what it is and what it can do.
    jbdragonwatto_cobra
  • Reply 40 of 40
    toddimt 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. 
    As does the Apple Watch.  
    Low heart rate is still heart rate.
    A-Fib is just an irregular rhythm of the heart rate.

    The difference is:  The Polar H7 & H10 are only sensors that pick up the same electrical signal the AW4 does   But, unlike the AW the polar sensors send the signal to a computer / smart phone via low energy bluetooth for interpretation and display.   The AW being self contained has no need to do that. 

    In fact, the iPhone has had 3rd party apps that have used the Polar H7 H10s to monitor heart rate variability -- which is an ultra fine version of looking for an arhythmia.

    The reason for the need for FDA approval was because Apple is using the word A-Fib.  To the FDA, medical claims matter.   For instance, only certain foods are allowed to claim they are heart healthy.    If they had put out the exact same hardware but not have claimed to identify A-Fib, they would not have needed the approvals or clearances.
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