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

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in Apple Watch
The two FDA clearances that Apple announced Wednesday for the Apple Watch Series 4's ECG capabilities came from data collected via the Apple Heart Study, according to a report Thursday.

Apple Watch warning


Apple announced Wednesday at its "Gather Round" event that the new Apple Watch Series 4 comes with the ability to take an electrocardiogram -- the first Apple product to receive clearance from the FDA. Apple COO Jeff Williams said on stage that the company received the clearances for its ECG and atrial fibrillation testing on the Apple Watch via a "de novo" pathway, which means it supplied data to the agency to prove the product both worked and is safe.

Quartz reported Thursday, citing FDA documents, that the FDA used data from the Apple Heart Study in order to grant Apple those clearances. That study, conducted by Apple along with Stanford Health, launched last November and began winding down earlier this month.

The Watch's abilities don't actually mean much, according to one doctor.

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.
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Comments

  • Reply 1 of 40
    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. 
    edited September 13 leighc-sfololliverfotoformatiqatedotmaySolirandominternetpersonwatto_cobra
  • Reply 2 of 40
    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.
    rich gregorywatto_cobra
  • Reply 3 of 40
    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. 
    StrangeDaysrepressthisRayz2016anton zuykovwatto_cobra
  • Reply 4 of 40
    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

    leighc-sfololliverRayz2016PickUrPoisonwatto_cobra
  • Reply 5 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.

    repressthisfotoformatArfshesaid...aaploutsiderlostkiwiGeorgeBMacrandominternetpersonrich gregoryviclauyyc
  • Reply 6 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. 
    GeorgeBMac
  • Reply 7 of 40
    A couple of things... I don't know what makes that doctor downplay the significance of ECG in a watch if he never tested it.

    While it is nowhere the same as the ECG in hospitals, having two separate electrodes can actually improve detection of different types of arrhythmias that was not possible with S3 or older. When arrhythmia is suspected, it's usually enough for you to go to ER. A-Fib can easily be detected with just two electrodes but requires further confirmation with more advanced ECG.

    It is easy for two electrodes ECG to detect tachycardia and can tell difference between some types of tachycardias. But more electrodes are needed and placed in right places to determine what type of tachycardia it is.
    edited September 13 StrangeDaysrepressthisiqatedoviclauyycwatto_cobra
  • Reply 8 of 40
    Just one more thing... why are there no paragraph breaks in Safari when I comment?!?! It annoys the heck out of me.
    space2001watto_cobra
  • Reply 9 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. 
    edited September 13 repressthisRayz2016Soliwatto_cobra
  • Reply 10 of 40

    netrox said:
    Just one more thing... why are there no paragraph breaks in Safari when I comment?!?! It annoys the heck out of me.
    You’re likely using the HTML-mode of the text editor, and not the normal WYSIWYG mode. 
    netroxrepressthisRayz2016watto_cobra
  • Reply 11 of 40
    Did Apple Watch 4 (AW4) 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 directly damage a wearer, though I wouldn't be at all surprised if AW4 gave false positives and negatives; forcing people to A&E Depts unnecessarily 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?
  • Reply 12 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?
  • Reply 13 of 40
    Cleared or approved? Let’s settle it once and for all. Mail to ask Jeff or Phil.

    https://www.nbcnews.com/health/health-news/new-apple-watch-has-heart-monitor-fda-approves-n908976
    edited September 14 watto_cobra
  • Reply 14 of 40
    Many medical industry professionals are saying that this watch is a Class II device, and Apple was granted "clearance" and not a real Class III FDA approval.  

    If that's the case, it shows you that Apple is that good at spinning the details.  They were "approved" to sell a Class II ECG device.  
  • Reply 15 of 40
    Many medical industry professionals are saying that this watch is a Class II device, and Apple was granted "clearance" and not a real Class III FDA approval.  

    If that's the case, it shows you that Apple is that good at spinning the details.  They were "approved" to sell a Class II ECG device.  
    Clearance only. Not approved. It is only a Class II device for over the counter use. It’s not intended to provide diagnosis. It is similar to a Lead 1 ECG. The user is not intended to to interpret or take clinical action based on device output. 

    https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180044.pdf
  • Reply 16 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. 
    If you were to read the clearance paper, you would know that they classify it as Lead I. 
  • Reply 17 of 40
    I have severe Dilated Cardiomyopathy and is on the heart transplant list. The ability to take even a simple 2 lead ECG would be of great help to my cardiologist. The fact that you can send them a PDF that they can interpret themselves is of great help. The watch itself might not be able to make a diagnosis from the results but a doctor can make a more informed decision. The fall detection would have helped me a lot in the past. I have fainted a number of times with extreme low blood pressure 66/42. I live alone and was lying on the floor for 40 odd minutes at one time before I came to and could phone for help. This have some real practical implications that cant be denied. It does not intent to replace your healthcare practitioner but acts as an aid and an early warning/alert system.
    GeorgeBMacrandominternetpersonwatto_cobra
  • Reply 18 of 40
    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.
    watto_cobra
  • Reply 19 of 40
    SoliSoli Posts: 8,366member
    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. 
    If you were to read the clearance paper, you would know that they classify it as Lead I. 
    That's what he said. Here's a pic of a single-lead EKG in use.  This is the standard setup.



    For comparison, here's a pic showing Lead II with its standard setup of the right arm and left leg. How exactly would that work with an Apple Watch? Touch your big toe to the Crown for 30 seconds?


    edited September 14 watto_cobra
  • Reply 20 of 40
    SoliSoli Posts: 8,366member
    netrox said:
    Just one more thing... why are there no paragraph breaks in Safari when I comment?!?! It annoys the heck out of me.
    I see paragraph breaks in your comment:

    Did Apple Watch 4 (AW4) 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 directly damage a wearer, though I wouldn't be at all surprised if AW4 gave false positives and negatives; forcing people to A&E Depts unnecessarily 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?
    Why are you ignoring all the irregular heart rates detected by the Apple Watch that have notified the wearer? Are you saying that none of these people could've possibly died or the Apple Watch caused even more people to die from letting them know it sensed something that should be checked out by a medical professional? Would you also tell ssomeone that condoms are pointless because you can't guarantee 100% success rate in stopping a pregnancy or STD?
    edited September 14 watto_cobra
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