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Apple Watch AFib History Feature Qualified by FDA to Evaluate Medical Devices
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Mine started pinging me that its detecting 2% AFIB. I asked my primary care physician and she wondered what they considered AFIB. She noted that getting amped up on coffee, or energy drinks, may induce AFIB-like conditions.
I then looked at the history, and its been showing this since 2022, but it only started notifying me recently. Weird.
I then looked at the history, and its been showing this since 2022, but it only started notifying me recently. Weird.
I actually had some episodes of Afib a while back (for the first time). I felt it and my Apple Watch also reported it.
Went to the ER, by then it was gone. ER tech wasn´t even interested in seeing the report on my iPhone. They gave me an appointment with a cardiologist.
Now, the cardiologist was very interested to see the report and he said it was a textbook-example of an Afib (not sure if I should be happy about that) and he was very upset that the ER tech didn't want to look at it.
I had my first reading of 2% two weeks ago but that's been it after ~4 months of having the watch.
The story might be a bit more complicated than that. Devices that are intended to be used as medical devices does need to meet certain data criteria for review and approval. I could be wrong but I would think that in the case of Apple, they weren't claiming the feature to be anything more than a wellness device in the beginning so it didn't need to meet a certain criteria.
Long story short is that it's not necessarily that FDA is the issue here. It also depends on what regulatory approval Apple is seeking.
Hmm. It's not good because it's better not to know? What? It saves lives and you're wondering if that's all it is?
All cardiologists look at the report. They may have issues with it in some regards, but they will test the findings with their own equipment and analysis.
Apple said they were working on the diabetes/blood sugar testing but never implied that it was imminent. That's not an easy one to get clearance from FDA.
Ironically, my cardiologist was able to diagnose my A.Fib by my Apple Watch readings. He looked at the instances of A.Fib recorded in the health app on my iPhone and considered that evidence enough to begin the process of discovering why I had A.Fib at such a young age. So apparently some cardiologists believe the Apple Watch is accurate enough when it comes to the ECG to consider its findings when it comes to diagnosing A.Fib.
I'm guessing Apple marketed the Afib feature as a wellness device because they didn't want to wait years for FDA approval as a medical device. If studies could be done faster, I think these features could be launched as more of a medical / analytical device (e.g. ECG came with Apple Watch 4. It should have been possible that by the time Apple enabled the Afib history feature, there were enough data points from academic studies that the FDA gave approval on launch)
Reality is many are self delusional on that subject. You trust 3 letter agencies everyday with your life and wellbeing some you don’t even know the letters.
I have heart issues since 2008 and use a applewatch as a first signal something is wrong for afib. Like any tool its just a tool. The nice thing is unlike going for a ecg its 24hours a day and keeps a eye on you. Does it work yes over last 3 years i have 4 afib 'periods'. One time it would not go away and a Cardioversion was needed. But the other times i could resolve it by changing my meds for a few days. My cardiologist in the netherlands allow you to send in the ecg from apple watches and take a look when needed but will also do their own (multipoint) ecg to confirm. I have never found the applewatch was wrong in detection but i guess that depends on person for me its a good help to detect it early and try deal with it. Having more information about these things is never bad if you don't get too stressed about it and if you see it for what it is just a signal/first step in possible detection. By bad luck after more than a year of no issues had a 3 day afib issue period last week that was resolved by upping some meds.
It must get exhausting to be upset over pleasant things.
Yes they do if i have afib warnings and confirm with a apple ecg i send it to my cardiologist. ask me to come in (i can walk to the hospital, 500meters) to confirm it with a full ecg and what todo most of the time a med change if longer than a few weeks or it bothers you too much (mostly get tired quicker) they zap you to get it back in ritme.
Just to show some examples for people maybe not so familiar with it.
The first one is an actual Afib episode. The other one is from the next morning. It doesn't exactly require rocket science to detect a difference. Every doctor will see that there was at least "something" in the first recording.
The first one is an actual Afib episode. The other one is from the next morning. It doesn't exactly require rocket science to detect a difference. Every doctor will see that there was at least "something" in the first recording.
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Yours look so well organised compared to some of mine... hehe sorry. Indeed even if the ecg is limited (only 1 channel) it does give them some info but they will probably do a full ecg to see more things. For personal use over a 'event' i find the HRV view also telling given that for most the extra beats are random. Here is my HRV from last weeks event for me it mostly jumps from 50-100 to 200-250 as a result of all the extra beats and random action.
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Just had an appointment with my GP - and she agreed completely with the story my Apple Watch tells.
Not much of an idea what to do about it, but that is definitely nothing to do with Apple!
Not much of an idea what to do about it, but that is definitely nothing to do with Apple!
My experience early on with my doctors is most dismissed the watch without seeing recordings. Now they ask if I have any.
Quoting myself here, since I do think this warning should be more clear.
Now it's just a notification and if one has "do not disturb" active it won't show. Please do disturb me – vigorously with flashes and haptics – if I’m at risk of damaging my hearing and get tinnitus and other ear issues that could be life long!
Would also likely keep more people interested in Apple Music since hearing problems can lessen the interest in listening to (and creating) music. Mine sure has fade a bit…
Feedback provided to Apple on this now.
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