1. Ken Magel's Avatar
    I have heard conflicting stories about whether or not the new heart monitor sensors are FDA approved. Are they? If not, is Apple trying to get approval for them?
    09-13-2018 10:53 AM
  2. digitalbreak's Avatar
    In the presentation they said it’s FDA approved. I believe they are on the last leg as this feature will be available soon to USA customers via a software update.
    09-13-2018 11:39 AM
  3. digitalbreak's Avatar
    Here is more information: https://www.theverge.com/2018/9/13/1...d-meaning-safe

    "The Apple Watch is in Class II. For Class II and Class I, the FDA doesn’t give “approval,” it just gives clearance. Class I and Class II products are lower-risk products — as Speer puts it, a classic Class I example is something like a tongue depressor — and it’s much easier to get clearance than approval."
    09-13-2018 12:12 PM
  4. btru82's Avatar
    I have heard conflicting stories about whether or not the new heart monitor sensors are FDA approved. Are they? If not, is Apple trying to get approval for them?
    They said it was in the keynote.
    09-14-2018 12:48 PM
  5. salscott's Avatar
    Well I've just been diagnosed with AFib and I think I'll give my son my aw3 and pick up the 4 because even my cardiologist said it would be useful. SG lte 44 it is
    Aztek13 likes this.
    09-14-2018 07:23 PM
  6. Raptor007's Avatar
    It will be very beneficial for monitoring heart issues, but doctors may not want patients with aFib using this as the key way to monitor. I can't recall the article but I know I read something about that earlier this week. I will have to go back over my past reading.
    09-15-2018 08:16 PM
  7. salscott's Avatar
    It will be very beneficial for monitoring heart issues, but doctors may not want patients with aFib using this as the key way to monitor. I can't recall the article but I know I read something about that earlier this week. I will have to go back over my past reading.
    The way my cardiologist positioned it was that it was useful for those who have been AFib and have had treatment to correct. I would use it as a tool to then get a proper ECG and follow up with cardiologist.
    09-15-2018 08:32 PM
  8. Raptor007's Avatar
    Valid point, I just wouldn't want someone to rely on it alone, seeking medial guidance is always best and this can be a positive way to monitor. I would like to see glucose monitoring at some point.
    09-16-2018 08:00 PM
  9. Ken Magel's Avatar
    How likely is the possibility of false negatives? ATo me that would be much more dangerous than other results. A false negative would be where the watch indicated you were fine or did not indicate anything when in fact a problem existed. Has Apple or Stanford published the rate of false negatives in their study? What would the FDA find acceptable to certify the device?
    09-20-2018 10:37 AM
  10. doogald's Avatar
    How likely is the possibility of false negatives?... Has Apple or Stanford published the rate of false negatives in their study?
    Yes, but only partially. See https://www.tomsguide.com/us/apple-w...ews-28081.html and https://www.statnews.com/2018/09/13/...watch-ekg-app/

    Apple submitted findings from two studies to the FDA as part of its submission to obtain clearance for the ECG app. According to STAT News, which obtained a summary of the findings from the FDA, the watch algorithm accurately identified 98.3 percent of people with atrial fibrillation, and correctly identified 99.6 percent of people who did not have atrial fibrillation. The study's sample size was 588 people.


    n one study, Apple tested the watch in more than 580 people, half of whom had atrial fibrillation. The app couldn’t read about 10 percent of the heart rhythm recordings in the study. When it looked at the rest, though, the app was very accurate: It caught more than 98 percent of people with atrial fibrillation, and correctly told people that they didn’t have the condition 99.6 percent of the time.


    So, 1.7% of a sample size of 529 people (588 people in the study, minus 10% who could't get a reading from the app) were false negatives (that's 9 people). Then again, these are people who would not have known anyway; presumably they probably would not have been wearing a heart rate monitoring device anyway, and probably were not wearing the AW specifically to determine if they had or did not have A-Fib.

    The bigger issue may be false positive.

    That figure is the app’s “positive predictive value,” and Kathiresan calculates that for people using Apple’s EKG app to look for atrial fibrillation, that number is about 45 percent. He based that calculation on the figures from the studies FDA shared.More than half the time the app flags a problem, then, the app will be wrong.
    [...]
    Doctors whose patient populations sport Apple Watches may need to brace themselves for an influx of patients who will want to see a specialist when they receive an irregular heart rhythm alert, Kathiresan said.


    That's a lot of potential visits to a Doctor and a lot of potential tests being done for a false positive.
    09-20-2018 01:51 PM
  11. Ken Magel's Avatar
    False negatives are more dangerous because they mean you are getting an assurance that is not correct. Then, even if you have mild symptoms, you might ignore them because the watch ays you have nothing to worry about.
    09-20-2018 02:11 PM
  12. Raptor007's Avatar
    The concern seems to be coming from how limited the data was, that Apple controlled the data and they knew who had aFib in the trial which is something you should not know. Any type of real medical data needs to be peer reviewed to insure accuracy of data. I do applaud Apples moves to focus on health in their devices, I just don't want people putting more faith into a device that may or may not be accurate without medical guidance to back them up.
    09-20-2018 02:54 PM
  13. doogald's Avatar
    False negatives are more dangerous because they mean you are getting an assurance that is not correct. Then, even if you have mild symptoms, you might ignore them because the watch ays you have nothing to worry about.
    I know several people who have A-Fib and all said that the symptoms were obvious - there was something obviously wrong when they had an incident. I think you are exaggerating the danger of people with A-Fib never seeing a warning on their Apple Watch (and remember that the watch isn't saying that you don't have A-Fib - it just wouldn't warn you if it didn't detect the symptoms.)
    09-21-2018 05:37 AM
  14. doogald's Avatar
    The concern seems to be coming from how limited the data was, that Apple controlled the data and they knew who had aFib in the trial which is something you should not know.
    I am sure that the 588 people were the control group in the study. I know that there were people who were not in the control group who did get detected by the Heart Study app (see this). Most people in the study did not have A-Fib; that was a determining factor to be in the study. If you were diagnosed as having A-Fib in the past, they did not select you. But of course they must have pre-selected a control group of participants sho had an A-Fib diagnosis so that they could see for sure if the AW Heart Study app could see the symptoms.
    09-21-2018 05:45 AM

Similar Threads

  1. Replies: 33
    Last Post: 09-20-2018, 02:28 PM
  2. Replies: 3
    Last Post: 09-17-2018, 08:32 AM
  3. YouTube Hands-on roundup after the iPhone XS event
    By iMore.com in forum iMore.com News Discussion
    Replies: 0
    Last Post: 09-13-2018, 10:50 AM
  4. Get the most out of your workouts with these new Polar watches
    By iMore.com in forum iMore.com News Discussion
    Replies: 0
    Last Post: 09-13-2018, 10:30 AM
  5. The $280 Kano Computer Kit Touch teaches you to build and code
    By iMore.com in forum iMore.com News Discussion
    Replies: 0
    Last Post: 09-13-2018, 08:10 AM
LINK TO POST COPIED TO CLIPBOARD