Apple Watch Series 4 is first consumer device to receive FDA clearance for ECG monitoring ...

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  • Reply 61 of 69
    melgrossmelgross Posts: 33,510member

    doctorA&E said:
    Hello everyone. I am very curious about how it works and on which bases the FDA gave the approval to this device. I am curious to know how it can read a 12 lead ecg reproducing it. Providing a simple lead it’s completely useless and it sounds only like a trade strategy to cheat people. So I invite everyone to be very cautious about this without any proven demonstration. The ECG records cardiac electricity that a mobile phone or a watch cannot do. So please let’s invite these engineers to play their PS4 and leave the medicine and very serious things to doctors, especially when it comes to the heart. 
    Quite frankly, that
    s a very stupid thing to say. The FDA doesn’t give certifications out for nothing. This is a Class 1 certification. As such it must meet accuracy and reliability standards the FDA uses. Is it as accurate as one in the doctors Office? Well, we really don’t know. But useless? That’s totally ridiculous. The president of the American Heart Association wouldn’t have come out and talked about it if it were. That would be very risky.
    SoliSpamSandwichwatto_cobraGeorgeBMac
  • Reply 62 of 69
    SoliSoli Posts: 10,035member

    Soli said:
    GeorgeBMac said:
     And it is never used in a medical setting.
    1) Never? So despite all the single-lead devices on the market you believe nary a one would ever be used by a health care professional? Not even a home nurse or a clinic?

    2) Do you have any evidence to support an implication that it offers no medical information that could save a life?

    But, the way it was presented as "an EKG" implied the regular medical grade EKG.

    If you had paid attention you'd see that they specifically said it was "similar to a Lead-1 ECG" at the 23m:51s mark of the presentation. Are you saying that's a lie?

    What about his statement a couple minutes earlier that this is the first device sold over the counter? That part seems most unlikely to me, not that their EKG tech is useless, because I can find EKG metes for sale from Amazon that don't seem to require a physicians approval to buy.

    2)  Nice misquote!  I never said or implied anything of the kind.
    GeorgeBMac wrote, “And [a single-lead ECG] is never used in a medical setting.”

    How exactly is that a misquote? I think your comment is quite clear… and quite clearly wrong.
    edited September 2018 watto_cobra
  • Reply 63 of 69
    melgrossmelgross Posts: 33,510member

    Soli said:
    doctorA&E said:
    Providing a simple lead it’s completely useless and it sounds only like a trade strategy to cheat people.b
    You think Apple and the FDA are cheating people? OK.

    So I invite everyone to be very cautious about this without any proven demonstration. The ECG records cardiac electricity that a mobile phone or a watch cannot do.
    We will be careful, but we won't more careful than the research Apple had done before submitting to the FDA, and the FDA in approving this device for the specific testing it's doing.

     So please let’s invite these engineers to play their PS4...
    WTF does the PS4 have to do with anything? Are you really suggesting that the Watch with its health features are equivalent to playing video games?  Stupid Apple and their foolish toys¡ :eyeroll:

    ...and leave the medicine and very serious things to doctors, especially when it comes to the heart.
    Do we need a doctor to take our pulse, too? How about doing cardio to stay healthy? Since that also falls under the silly "especially when it comes to the heart" umbrella you clearly haven't thought this through.

    The real question is why you're intimidated by a damn electronic device.
    Because, you know...it’s Apple.
    watto_cobra
  • Reply 64 of 69
    melgrossmelgross Posts: 33,510member

    I want to learn more about this.
    Medical ECGs all use 12 leads to get a full read out -- and from that the physician can tell an unbelievable amount of information -- even if you've had a heart attack in the past.   The information goes far beyond a simple arrhythmia.

    I was under the impression that a single lead EKG could only measure heart rate (and if precise enough, it's rhythm).   And, that is precisely what the "old" chest straps that runners and cyclists used did.   They were single lead EKGs.

    But, here Apple was implying without saying explicitly that this provided a full boat EKG -- and their picture of an EKG readout certainly made it look so.  And I trust Apple to not bamboozle us.

    So, I'm looking forward to additional information and clarity.  What I saw in the Apple presentation did not jibe well with what I learned (and mostly forgot) about EKGs.
    This was exactly my thought. It was mentioned in the presentation that it’s a level 1 ECG but I’ve not been able to find from a search whether that is a lower level type or applies to all. Frankly I can’t see the benefit, at least not in a country like the UK, and plenty of downsides. It’s not like HR which it is useful and informative to regularly check. I can’t see why any of us would need or want to regularly have an ECG, especially if it is one less useful and informative than a 12 lead reading. Here in the UK ECGs are done fairly routinely when patients present at a and e, or at their General Practitioners with certain problems, and possibly as standard when registering with a GP and/or going for a health check. I fear some people may now unnecessarily waste GP time after doing lots of home ECGs and either getting inaccurate readings or needing them explained. 
    If you feel that your heart is racing, or you get a feeling of them;I gotta, which peop,e do get, this can be a quick check to see if something is off. If you’re doing  and want to see if your heart is running normally, this is good. It doesn’t have to measure everything.
    watto_cobra
  • Reply 65 of 69
    melgrossmelgross Posts: 33,510member

    Soli said:
    mpw_amherst said:
    I can’t see why any of us would need or want to regularly have an ECG, especially if it is one less useful and informative than a 12 lead reading.
    Who does periodic 12-lead EKG checks at home? I certainly don't, so if this is just 30 seconds from my Watch I will be more likely to do it. If that tells me that I then need to see a doctor and the doctor then does a more extensive EKG then I don't see a downside. 

    This sounds like people saying that the iPhone camera isn't as good as this or that DSLR with a bulky size and removable lenses all with a huge cost. As they say, the best camera is the one you have with you, so why wouldn't the best EKG be the one you have with you (which in no way states that if you're at a doctor's office that you shouldn't use a more accurate device).
    Well quite. But this is also my point. Who does, or more importantly needs, regular ECGs? The answer: no one. If you have AF then you’ll be alerted by several obvious symptoms anyway. And it’s unclear that this will provide an ECG with any more useful data of function than scanning for AF. I just don’t see this as having much real world use beyond a gimmick. As mentioned elsewhere, oxygen sats, glucose levels - would be far more useful. 
    You’re making a statement that you know nothing about. Medicine is advancing on a regular basis. The holy grail is for constant monitoring of basic bodily functions. At some point we’ll get to the end of it, but that’s a while off. Meanwhile, this is a good compromise.
    watto_cobra
  • Reply 66 of 69
    melgrossmelgross Posts: 33,510member
    Soli said:
    Soli said:
    mpw_amherst said:
    I can’t see why any of us would need or want to regularly have an ECG, especially if it is one less useful and informative than a 12 lead reading.
    Who does periodic 12-lead EKG checks at home? I certainly don't, so if this is just 30 seconds from my Watch I will be more likely to do it. If that tells me that I then need to see a doctor and the doctor then does a more extensive EKG then I don't see a downside. 

    This sounds like people saying that the iPhone camera isn't as good as this or that DSLR with a bulky size and removable lenses all with a huge cost. As they say, the best camera is the one you have with you, so why wouldn't the best EKG be the one you have with you (which in no way states that if you're at a doctor's office that you shouldn't use a more accurate device).
    Well quite. But this is also my point. Who does, or more importantly needs, regular ECGs? The answer: no one. If you have AF then you’ll be alerted by several obvious symptoms anyway. And it’s unclear that this will provide an ECG with any more useful data of function than scanning for AF. I just don’t see this as having much real world use beyond a gimmick. As mentioned elsewhere, oxygen sats, glucose levels - would be far more useful. 
    Does the average person need regular heart rate monitoring? Apparently not since it wasn't common on CE until the Apple Watch and yet there have been many lives saved because of it, including people on this forum, so I'm not sure what you're getting at by saying that AFib detection won't help save a single life.

    edit: Note that the presenter specifically refers to a "Lead-1 ECG." If that's such a pointless test then why are there so many single-lead EKG medical devices on the market? Do you think Apple paid off cardiologist Ivor Benjamin with what you seem to think is a bogus medical device?


    Yeah,  I’m one of the saved. There are people who oppose advances just because that’s what they do. The old “If it’s good enough for my father, then it’s good enough for me” syndrome. Others would oppose it just because it’s Apple that’s done it. Lots of those out there, and here too.
    Soliwatto_cobra
  • Reply 67 of 69
    melgrossmelgross Posts: 33,510member

    melgross said:
    melgross said:

    An FDA-approved medical grade device that allows easy collection and delivery of historical ECG data to a doctor.  Hmm.  Sounds like a device that might be covered by insurance, and might be subsidized by employers.  
    Apple watches and some FitBit devices are already subsidized by some insurance companies, and given to their employees. This will just make it closer to ubiquity.
    Would the watch qualify as a medical expense covered by an HSA?
    I don’t know.
    Will you be getting one -- in light of the benefit you got from the one you have?
    I tried to order it earlier, forgetting that it’s not Friday yet. At 12:01 tonight, I’ll order the black SS with cell model to replace my series two of the same type. My wife said, that in consideration of what happened, no cost is too great. She’s going to take my series 2.
    watto_cobraGeorgeBMac
  • Reply 68 of 69
    SoliSoli Posts: 10,035member
    melgross said:
    Soli said:
    Soli said:
    mpw_amherst said:
    I can’t see why any of us would need or want to regularly have an ECG, especially if it is one less useful and informative than a 12 lead reading.
    Who does periodic 12-lead EKG checks at home? I certainly don't, so if this is just 30 seconds from my Watch I will be more likely to do it. If that tells me that I then need to see a doctor and the doctor then does a more extensive EKG then I don't see a downside. 

    This sounds like people saying that the iPhone camera isn't as good as this or that DSLR with a bulky size and removable lenses all with a huge cost. As they say, the best camera is the one you have with you, so why wouldn't the best EKG be the one you have with you (which in no way states that if you're at a doctor's office that you shouldn't use a more accurate device).
    Well quite. But this is also my point. Who does, or more importantly needs, regular ECGs? The answer: no one. If you have AF then you’ll be alerted by several obvious symptoms anyway. And it’s unclear that this will provide an ECG with any more useful data of function than scanning for AF. I just don’t see this as having much real world use beyond a gimmick. As mentioned elsewhere, oxygen sats, glucose levels - would be far more useful. 
    Does the average person need regular heart rate monitoring? Apparently not since it wasn't common on CE until the Apple Watch and yet there have been many lives saved because of it, including people on this forum, so I'm not sure what you're getting at by saying that AFib detection won't help save a single life.

    edit: Note that the presenter specifically refers to a "Lead-1 ECG." If that's such a pointless test then why are there so many single-lead EKG medical devices on the market? Do you think Apple paid off cardiologist Ivor Benjamin with what you seem to think is a bogus medical device?


    Yeah,  I’m one of the saved. There are people who oppose advances just because that’s what they do. The old “If it’s good enough for my father, then it’s good enough for me” syndrome. Others would oppose it just because it’s Apple that’s done it. Lots of those out there, and here too.
    As they said during the event yesterday regarding the fall detection and auto-call to family or emergency service (paraphrased), "we hope you never need to use it, but it's there in case you do."
    watto_cobra
  • Reply 69 of 69
    melgrossmelgross Posts: 33,510member
    Soli said:
    melgross said:
    Soli said:
    Soli said:
    mpw_amherst said:
    I can’t see why any of us would need or want to regularly have an ECG, especially if it is one less useful and informative than a 12 lead reading.
    Who does periodic 12-lead EKG checks at home? I certainly don't, so if this is just 30 seconds from my Watch I will be more likely to do it. If that tells me that I then need to see a doctor and the doctor then does a more extensive EKG then I don't see a downside. 

    This sounds like people saying that the iPhone camera isn't as good as this or that DSLR with a bulky size and removable lenses all with a huge cost. As they say, the best camera is the one you have with you, so why wouldn't the best EKG be the one you have with you (which in no way states that if you're at a doctor's office that you shouldn't use a more accurate device).
    Well quite. But this is also my point. Who does, or more importantly needs, regular ECGs? The answer: no one. If you have AF then you’ll be alerted by several obvious symptoms anyway. And it’s unclear that this will provide an ECG with any more useful data of function than scanning for AF. I just don’t see this as having much real world use beyond a gimmick. As mentioned elsewhere, oxygen sats, glucose levels - would be far more useful. 
    Does the average person need regular heart rate monitoring? Apparently not since it wasn't common on CE until the Apple Watch and yet there have been many lives saved because of it, including people on this forum, so I'm not sure what you're getting at by saying that AFib detection won't help save a single life.

    edit: Note that the presenter specifically refers to a "Lead-1 ECG." If that's such a pointless test then why are there so many single-lead EKG medical devices on the market? Do you think Apple paid off cardiologist Ivor Benjamin with what you seem to think is a bogus medical device?


    Yeah,  I’m one of the saved. There are people who oppose advances just because that’s what they do. The old “If it’s good enough for my father, then it’s good enough for me” syndrome. Others would oppose it just because it’s Apple that’s done it. Lots of those out there, and here too.
    As they said during the event yesterday regarding the fall detection and auto-call to family or emergency service (paraphrased), "we hope you never need to use it, but it's there in case you do."
    It’s like insurance. I’ve been taking readings since I got my first one whenever I did something that would add stress. In my shops, I move some of my equipment, which can be heavy. I’ll put a 75 pound chuck on my big lathe, or a heavy chunk of steel on the bed of my mill, for example. I like to see where my heart rate is at that time. It’s a good standard number in case something happens, and it’s much higher than usual. Because, otherwise, how do you know?

    you're more likely to have afib when being stressed. It’s not at all uncommon for the heart to miss some beats, or to add some. But if it happens frequently, then it’s time for help. If you feel that’s happening, taking this reading can tell you whether it’s real, or you’re imagining it, which can happen too.

    I've spoken to my cardiologist (sheesh, I never thought I’d have one) about this, and she’s pretty stoked about it, even though I’ve been tested up and down, and don’t have any sign of afib. She said that it can indicate other things as well, if you’re trained to see it. The fact that the readings are recorded in the health app is great for this.
    edited September 2018 watto_cobra
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