Apple Heart Study not used to gain FDA clearance for Apple Watch Series 4 ECG

Posted:
in Apple Watch edited November 1
The Apple Heart Study, conducted in partnership with Stanford Medicine, collected heart rate data from more than 400,000 Apple Watch users in its attempt to determine whether wearable devices can effectively detect irregular heart rhythms. Contrary to previous reports, however, the results were not used to gain clearance from the U.S. Food and Drug Administration for Apple Watch Series 4's ECG feature.

Apple Watch ECG
The ECG app on Apple Watch Series 4.


Stanford revealed the scope of the Apple Heart Study in an announcement Thursday, saying the clinical trial was the largest screening study on atrial fibrillation ever conducted. A paper detailing the study and its design was published in the American Heart Journal today.

Apple closed enrollment in August, some eight months after it launched the program in 2017. Participants began receiving word that the study was complete in September, though Stanford says data collection will be completed early next year, in line with previous statements from Apple.

Following the closure to enrollment, Apple quietly submitted a de novo request for FDA clearance to two Apple Watch apps that would feature prominently in Apple Watch Series 4. The first app handles interpretation of and display of electrocardiogram readings from the wearable's new ECG system, while a second uses optical sensors to identify irregular heart rhythms.

The FDA issued regulatory Class II clearances -- over-the-counter access -- for both.

Previous reports claimed Apple leveraged the Heart Study in both de novo requests, but Stanford says the trial was used only in respect to atrial fibrillation notifications.

The clarification makes sense, as the Heart Study related to atrial fibrillation, not ECG systems or data collection. During the months-long trial, a specialized app collected pulse rate data from Apple Watch Series 1, 2 and 3 hardware. In some cases, the app was able to detect and notify users of irregular pulse rate episodes.

The study, according to Stanford, sought to determine how many patients who received irregular pulse notifications were found to have atrial fibrillation, and how many went on to get medical attention. Calculating the accuracy of the system against simultaneous ECG recordings was a tertiary goal of the trial.

Though it did not factor into regulatory approval of Apple's ECG solution as previously thought, the Heart Study can be considered an important first step toward providing consumers with easily accessible medical hardware.

"We now have access to high-quality sensors that can measure and detect changes in our bodies in entirely new and insightful ways without even needing to go to the doctor, but we need to rigorously evaluate them," said Mintu Turakhia, MD, associate professor of cardiovascular medicine at Stanford. "There's never really been a study like this done before."

Apple is expected to activate the ECG feature in Apple Watch Series 4 later this year.

Comments

  • Reply 1 of 11
    asciiascii Posts: 5,939member
    Good to hear, I'm glad it had purely for scientific motivations.
    watto_cobra
  • Reply 2 of 11
    Rayz2016Rayz2016 Posts: 4,349member
    ascii said:
    Good to hear, I'm glad it had purely for scientific motivations.
    Agreed. 

    It could have been seen as Apple influencing the decision to clear it. 
    watto_cobra
  • Reply 3 of 11
    ....and when can we expect the release, not just in the US but other countries?
    watto_cobra
  • Reply 4 of 11
    Rayz2016 said:
    ascii said:
    Good to hear, I'm glad it had purely for scientific motivations.
    Agreed. 

    It could have been seen as Apple influencing the decision to clear it. 
    Actually, in the world of medicine, NOT influencing FDA decisions is the exception.   Physicians and researchers recognize that the greatest single determinant of the outcome of any trial is who funded it.

    Typically, they claim RCTs as the "gold standard".  But, while the data is usually pretty clean, the results can be affected both by the design and analysis of the trial (Proving that a KitKat is healthy by comparing it to a Twinky is a tried and true tactic).   And, if that fails, trials that demonstrate results unfavorable to the funder are simply not published.
    Rayz2016watto_cobra
  • Reply 5 of 11
    I was wondering how that study would have had bearing on the ECG function. Sure the AW's ECG feature can help sniff out AF, but the heart study was testing with a different set of sensors, it wouldn't have been relevant for getting the OTC approval for the ECG function.

    Also about those OTC FDA approvals. While receiving FDA approval is a sign of the ECG feature having a high degree of accuracy, certain consumer medical devices can be approved even if there is a chance they could provide imperfect information. The FDA already approves a range of devices which have varying degrees of accuracy, as they suit different use cases. A single-lead ECG Apple Watch has significant benefits over the risks.

    A good parallel to think about is the home pregnancy test kit. Yes it can provide a false positive, but it's allowable because the risks associated with false positives are low and it keeps medical costs down while unclogging the system for more urgent care. Those with a positive result can seek a medical professional for higher certainty in a single appointment, rather than an appointment every time there are symptoms.
    The same applies with the ECG - it's going to help reduce the workload on medical professionals, especially as irregular heart behaviours can't be reproduced on command in the window of a doctor's appointment and that other symptoms(such as muscular spasms or digestion) can feel like issues with the heart.
    MacProwatto_cobra
  • Reply 6 of 11
    MacProMacPro Posts: 17,736member
    Looking forward to the updated software, it is why I bought the Watch 4.
    watto_cobra
  • Reply 7 of 11
    GeorgeBMacGeorgeBMac Posts: 3,108member
    I was wondering how that study would have had bearing on the ECG function. Sure the AW's ECG feature can help sniff out AF, but the heart study was testing with a different set of sensors, it wouldn't have been relevant for getting the OTC approval for the ECG function.

    Also about those OTC FDA approvals. While receiving FDA approval is a sign of the ECG feature having a high degree of accuracy, certain consumer medical devices can be approved even if there is a chance they could provide imperfect information. The FDA already approves a range of devices which have varying degrees of accuracy, as they suit different use cases. A single-lead ECG Apple Watch has significant benefits over the risks.

    A good parallel to think about is the home pregnancy test kit. Yes it can provide a false positive, but it's allowable because the risks associated with false positives are low and it keeps medical costs down while unclogging the system for more urgent care. Those with a positive result can seek a medical professional for higher certainty in a single appointment, rather than an appointment every time there are symptoms.
    The same applies with the ECG - it's going to help reduce the workload on medical professionals, especially as irregular heart behaviours can't be reproduced on command in the window of a doctor's appointment and that other symptoms(such as muscular spasms or digestion) can feel like issues with the heart.

    I too wondered about using the heart study to get the EKG function approved.   But I think ai explained it when they said these were two separate requests:  One for the EKG and the other for the ongoing monitoring of irregular heart rates using the optical sensors (below).

    As for the consumer vs medical device thing:   I have no way of assessing the accuracy of the Apple Watch for EKGs.   But regardless, the biggest difference between it and a medical grade EKG is the medical machines use a 12 lead device which provides additional information not possible with a single lead like that of the Apple Watch.
     

    Following the closure to enrollment, Apple quietly submitted a de novo request for FDA clearance to two Apple Watch apps that would feature prominently in Apple Watch Series 4. The first app handles interpretation of and display of electrocardiogram readings from the wearable's new ECG system, while a second uses optical sensors to identify irregular heart rhythms.

    The FDA issued regulatory Class II clearances -- over-the-counter access -- for both.

    edited November 2
  • Reply 8 of 11
    Actually, in the world of medicine, NOT influencing FDA decisions is the exception.   Physicians and researchers recognize that the greatest single determinant of the outcome of any trial is who funded it.

    Typically, they claim RCTs as the "gold standard".  But, while the data is usually pretty clean, the results can be affected both by the design and analysis of the trial (Proving that a KitKat is healthy by comparing it to a Twinky is a tried and true tactic).   And, if that fails, trials that demonstrate results unfavorable to the funder are simply not published.
    Actually, I've been working in medical devices for a while now, and I can say that while you are suitably cynical for the age, the "who" does not outweigh the "what" and the "how". Our medical device testing division is still waiting for the "who" (Big Med and Big Pharma) to deliver our first influence / overt / covert payment, and the test lab issues the study protocols and the study report, not the sponsors. But go ahead with your misunderstanding if you must.

    Physicians, and to a much lesser extent, researchers, are not always the best at determining anything, because they don't have access to all the data (deliberately so), and their perspective is often skewed by their own skill level, or lack of it, and attention to clinical data recording and patient followup requirements.

    Unfavorable trials may indeed not be submitted ("published" is the wrong word to use), but they are a permanent part of the Design History File, and/or the Device History Record, depending on the stage of development. Any attempt to bury things like that will buy you jail time and significant fines when discovered by FDA and it doesn't match the data you submitted.
    andrewj5790watto_cobra
  • Reply 9 of 11
    GeorgeBMacGeorgeBMac Posts: 3,108member
    13485 said:
    Actually, in the world of medicine, NOT influencing FDA decisions is the exception.   Physicians and researchers recognize that the greatest single determinant of the outcome of any trial is who funded it.

    Typically, they claim RCTs as the "gold standard".  But, while the data is usually pretty clean, the results can be affected both by the design and analysis of the trial (Proving that a KitKat is healthy by comparing it to a Twinky is a tried and true tactic).   And, if that fails, trials that demonstrate results unfavorable to the funder are simply not published.
    Actually, I've been working in medical devices for a while now, and I can say that while you are suitably cynical for the age, the "who" does not outweigh the "what" and the "how". Our medical device testing division is still waiting for the "who" (Big Med and Big Pharma) to deliver our first influence / overt / covert payment, and the test lab issues the study protocols and the study report, not the sponsors. But go ahead with your misunderstanding if you must.

    Physicians, and to a much lesser extent, researchers, are not always the best at determining anything, because they don't have access to all the data (deliberately so), and their perspective is often skewed by their own skill level, or lack of it, and attention to clinical data recording and patient followup requirements.

    Unfavorable trials may indeed not be submitted ("published" is the wrong word to use), but they are a permanent part of the Design History File, and/or the Device History Record, depending on the stage of development. Any attempt to bury things like that will buy you jail time and significant fines when discovered by FDA and it doesn't match the data you submitted.
    You quite obviously either have no idea what you're talking about -- or you're just spreading pro-industry propaganda.

    What I said is not "cynicism".   It's just common knowledge in the healthcare industry.   It's why they will not accept the results from any trial that has not been peer reviewed.
  • Reply 10 of 11
    You quite obviously either have no idea what you're talking about -- or you're just spreading pro-industry propaganda.

    What I said is not "cynicism".   It's just common knowledge in the healthcare industry.   It's why they will not accept the results from any trial that has not been peer reviewed.
    Saying it's common knowledge just means you don't have to cite your source. 

    FDA focuses IND and IDE reviews on safety and ensuring that the study will provide useful information once completed. NDA and PMA review is on the data itself and on data analyses, NOT on expert reports. 

    Since (apparently) you've never had to try to reason with FDA, or be subject to their repeated unannounced inspections, or re-conduct a clinical, it's hard to say I'm spreading propaganda for anybody. This industry can take years off of your life.

    It's simply a fact that physicians don't have all the data in a clinical because that's the way trials are constructed, the research data and clinical data are part of the permanent records, and you will go to jail, or at least lose your worldly possessions, if you fail to play by the rules. Yes, many try to skate (I have issues with several big corps in the industry), and some cheat for a while, but sooner or later you get caught and maybe you're lucky if FDA just decides they're taking over several prime office spaces in your company for the next five years while they look at every document in the building. I've seen that exact thing happen up close. 483s are just the beginning of the misery.

    You know they carry badges, right, and the US Marshalls are number one on their speed dial? This shit is real, and they'll lock your doors.
  • Reply 11 of 11
    13485 said:
    You quite obviously either have no idea what you're talking about -- or you're just spreading pro-industry propaganda.

    What I said is not "cynicism".   It's just common knowledge in the healthcare industry.   It's why they will not accept the results from any trial that has not been peer reviewed.
    Saying it's common knowledge just means you don't have to cite your source. 

    FDA focuses IND and IDE reviews on safety and ensuring that the study will provide useful information once completed. NDA and PMA review is on the data itself and on data analyses, NOT on expert reports. 

    Since (apparently) you've never had to try to reason with FDA, or be subject to their repeated unannounced inspections, or re-conduct a clinical, it's hard to say I'm spreading propaganda for anybody. This industry can take years off of your life.

    It's simply a fact that physicians don't have all the data in a clinical because that's the way trials are constructed, the research data and clinical data are part of the permanent records, and you will go to jail, or at least lose your worldly possessions, if you fail to play by the rules. Yes, many try to skate (I have issues with several big corps in the industry), and some cheat for a while, but sooner or later you get caught and maybe you're lucky if FDA just decides they're taking over several prime office spaces in your company for the next five years while they look at every document in the building. I've seen that exact thing happen up close. 483s are just the beginning of the misery.

    You know they carry badges, right, and the US Marshalls are number one on their speed dial? This shit is real, and they'll lock your doors.
    Sorry, but Big Pharma -- where most of the trials originate -- is focused on its profits.   No, they are not able to get every drug through the FDA.   But their focus, rather than developing accurate, complete  and reliable clinical trials is getting that product to market and then promoting it -- and collectively, they spend hundreds of millions (or more) to do that.  And, they do whatever they can to make that happen -- including insuring that clinical trials come out in their favor.

    Really, things haven't changed a lot since the Tobacco companies "proved" that smoking was not harmful to your health. 

    Sorry, but physicians and healthcare professionals are the ones who see the effects of these so called "proven safe and effective" trials and they know to be very skeptical.  It's why they won't accept them until they have been peer reviewed and duplicated elsewhere.

    Sorry that you have had a bad experience with regulation.  But that doesn't change reality.
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