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Apple Watch and Fitbit users with pre-existing heart conditions benefit from health data, going against FDA approval

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Summary

 

It turns out people with Apple Watches or Fitbit watches are more prone to visit the doctor due to the notifications these watches have about irregular heartbeats. A study found that individuals with atrial fibrillation using smartwatches with these sorts of features were able to gather more data about their condition and were more sensitive to using more health care resources than those who did not have smartwatches. Interestingly enough, at least the Apple Watch is FDA approved only to those WITHOUT existing heart problems, but this didn't stop people from using the data provided to help cardiologists diagnose the status of an existing heart condition of a patient.

 

Quotes

Quote

Cardiologists regularly see patients who have been diagnosed with atrial fibrillation bring in data from an Apple Watch or Fitbit, says study author Libo Wang, a cardiology fellow at the University of Utah School of Medicine. “There are a good amount of patients who are using these wearables outside of the FDA cleared indication,” he says. “That was sort of the motivation to start, not raising the alarm, but raising questions.”  - Libo Wang, study author

 

Quote

The study looked at 125 people with atrial fibrillation who visited University of Utah Health during a 90-day period and who mentioned using a wearable including an Apple Watch or a Fitbit. The team compared them to a group of 500 people with the same condition who didn’t use a wearable but had similar characteristics — including age, socioeconomic status, and the amount of times they typically went to see a doctor. - The Verge

 

My thoughts

It's really cool to see that smartwatches which are seen as more of a gimmick by some can actually be used to benefit one's health and help with providing data about heart problems that could help individuals seek help in a timely manner. The chances are that some of the people who got these watches would've never gone to the doctor without being notified about an irregular heartbeat, and maybe this will motivate companies more to create devices that give as accurate health information to customers as possible. I personally would see such a thing as a major selling point for smartwatches, and a very welcome one at that.

 

Sources

https://www.theverge.com/2021/6/2/22463322/wearables-afib-apple-fitbit-doctor-visit

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2780408

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FDA Cleared and FDA Approved are not the same. I see this mistake in a lot of places. Specially from merchants and OEMs trying to mislead consumers into thinking a medical device or product is effective.

 

FDA Approved means the FDA has overseen several double blind trials, inspected manufacturing facilities, and has found concrete evidence the medicine treats a condition or a device does a diagnosis or performs a task. It’s usually costs $1-2 billion to bring a new medicine to the market and get it approved by the FDA.

 

FDA Cleared means the FDA has not found a device or product to be harmful. It makes no claims about its effectiveness or accuracy.

 

There are many products like home laser hair removal kits that go for $500 that are FDA Cleared. It fools consumers into thinking this thing works. But they don’t. All the FDA found is that this device won’t cause a health problem. Another example is herbs and supplements. When an herb bottle says it’s FDA Cleared it only means the contents have not been found to be poisonous or carcinogenic.

 

I’ve read that Apple in partnership with a lab has done their own studies on the effectiveness of the Apple Watch but that’s not the same as doing a study under the FDA oversight for medical device approval. That would cost Apple a bunch.

 

I like the Apple Watch but I wouldn’t recommend it as a medical device. Every small form factor medical device that I’ve seen is much trickier to operate than the professional one. For example those BP monitors that you wear around your wrist are extremely sensitive to the pose of your arm. If I made a device that told 0.1% of its users to get an EKG, I bet at least some of them will find a heart condition.

 

Unless the Fitbit and Apple Watch go through the FDA medical device approval process, we can’t know if they are any good.

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Even if products like the Apple Watch and Fitbits aren't exactly FDA approved, if they can provide their users a source of information about their own biometrics in order to make better informed decisions about going to the doctors or not, I guess its a good thing. I'm not going to rely on anything like that as gospel, but its useful to at least gauge if I should go to an actual doctor with specialized medical instruments for further checkups as these users have done.

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I must say, ever since i got my first Apple Watch, i have become obsessed with watching my rested heartrate to the point where i know what's normal for me under specific circumstances and can tell when something's up, i think it's great to be more aware of what your norms are so that you'll be able to notice when something isn't right. 

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I'm gonna drop in another angle on this. I used to work for Nike tech support and so we dealt with a ton of apple watches using the nike run club app. Something I was told there, and I'm not sure if true, was that the Apple Watch was wildly inaccurate on these numbers and while it got more people talking to their doctors, the doctors were just dealing with a bunch of people thinking they've got a disease cuz they saw a strange number on their apple watch and ran to the doctor to make sure they're not dying. The vibe over at Nike tech support was very much that the heartrate monitor for those was garbage and doctors were constantly explaining to people to stop trusting it. 
Again this isn't my opinion, just an opinion I was told, not sure at all how true it is

Insanity is not the absence of sanity, but the willingness to ignore it for a purpose. Chaos is the result of this choice. I relish in both.

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3 hours ago, Jtalk4456 said:

 The vibe over at Nike tech support was very much that the heartrate monitor for those was garbage and doctors were constantly explaining to people to stop trusting it. 
 

My opinion is that the heart rate monitor on the fitbit, and likely the Apple Watch are "accurate enough", to get a real-time read, but people tend to not wear these things properly. (For example the sleep monitor on the fitbit needs the device to be warm snug enough) 

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This doesn't sound like a bad thing. I've compared my series 4 and series 6 data with that of my primary care physician and it was basically the same. Note the S6 was much more accurate though. Within 2bpm while the S4 was within +-13bpm. It's also extremely useful to see when you are going to get sick, how in shape you are, how much sleep you got including REM cycles, hearing loss prevention, fall monitoring, and other various health conditions. IMO it's the greatest purchase I've ever made

▓ƆԀ▓ S▓₱▓Ɇ▓c▓s▓: i7 6ʇɥפᴉƎ00K (4.4ghz), Asus DeLuxe X99A II, GT҉X҉1҉0҉8҉0 Zotac Amp ExTrꍟꎭe),Si6F4Gb D???????r PlatinUm, EVGA G2 Sǝʌǝᘉ5ᙣᙍᖇᓎᙎᗅᖶt, Phanteks Enthoo Primo, 3TB WD Black, 500gb 850 Evo, H100iGeeTeeX, Windows 10, K70 R̸̢̡̭͍͕̱̭̟̩̀̀̃́̃͒̈́̈́͑̑́̆͘͜ͅG̶̦̬͊́B̸͈̝̖͗̈́, G502, HyperX Cloud 2s, Asus MX34. פN∩SW∀S 960 EVO

Just keeping this here as a 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I had a family member who was warned last month that their heart rate was erratic. They ended up finding out that they had a heart condition that needs to be treated because of their Apple Watch. 
 

Also, my brother was in a moderately bad car accident last year and his Samsung watch detected it and automatically called his emergency contact. We were able to call 911 for him while he was still dazed. 

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Still waiting to even get any of the functionality on my Apple Watch 5. Which is really annoying and not a single person could tell me who or what is the reason for this "blocking". Is it my country laws or is it Apple? I have no clue. I just know I have an expensive gadget that should have all these awesome, sometimes life saving features that simply refuse to work. And it's really annoying. It'll soon be 2 years after launch of AW5 and still nothing if you don't live in US? Ugh!?

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38 minutes ago, RejZoR said:

Still waiting to even get any of the functionality on my Apple Watch 5. Which is really annoying and not a single person could tell me who or what is the reason for this "blocking". Is it my country laws or is it Apple? I have no clue. I just know I have an expensive gadget that should have all these awesome, sometimes life saving features that simply refuse to work. And it's really annoying. It'll soon be 2 years after launch of AW5 and still nothing if you don't live in US? Ugh!?

I think we have all the features enabled, at least ECG is enabled here. My guess it's more up to individual countries than anything.

 

You just have to move to another EU country 😉  

 

EDIT:// For the record I have a AW6 so I know above is true for that at least

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11 hours ago, Jet_ski said:

FDA Cleared and FDA Approved are not the same.

Wow...I went a-googling because I was sure I remember the term "FDA approved" being used, and fell into a wormhole that included reading the FDA's letter to apple about the watch, and yeah, there's a lot of sloppy usage of the terms.

 

I did find Forbes as the most "authoritative" site, and it does use "cleared" Wild.  Thanks for the info!

https://www.forbes.com/sites/jeanbaptiste/2018/09/14/apple-watch-4-is-now-an-fda-class-2-medical-device-detects-falls-irregular-heart-rhythm/?sh=4f765f432071

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For the record I am not American and have very little knowledge on anything having to do with the FDA and how they function, I just thought it was an interesting thing to point out. I certainly don't think any smartwatches should be used as a medical device, but I find it very nice that such watches can maybe nudge someone into visiting a doctor if there really is a need for it. Some like to ignore health related issues with themselves and only go to a doctor when the situation gets to a really bad point, and perhaps smartwatches can help these sorts of individuals in taking action sooner, but by no means should smartwatches be relied upon for strictly medical data. If the device is accurate enough, I don't see why it shouldn't notify the user about a potential issue.

 

9 hours ago, Sorenson said:

I had a family member who was warned last month that their heart rate was erratic. They ended up finding out that they had a heart condition that needs to be treated because of their Apple Watch. 
 

Also, my brother was in a moderately bad car accident last year and his Samsung watch detected it and automatically called his emergency contact. We were able to call 911 for him while he was still dazed. 

 

This is really cool and exactly the sort of stuff that makes me think smartwatches can be a lifesaver in some cases. Didn't even know that the Samsung watches had such features, only just recently started using my Garmin Vivoactive again, tempted to get something else. What did the watch do when contacting the emergency contact? Is there some sort of a message that they are sent with specific information? Sounds like something from a futuristic movie tbh

 

 

 

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1 hour ago, PixelDust said:

For the record I am not American and have very little knowledge on anything having to do with the FDA and how they function, I just thought it was an interesting thing to point out. I certainly don't think any smartwatches should be used as a medical device, but I find it very nice that such watches can maybe nudge someone into visiting a doctor if there really is a need for it. Some like to ignore health related issues with themselves and only go to a doctor when the situation gets to a really bad point, and perhaps smartwatches can help these sorts of individuals in taking action sooner, but by no means should smartwatches be relied upon for strictly medical data. If the device is accurate enough, I don't see why it shouldn't notify the user about a potential issue.

 

 

This is really cool and exactly the sort of stuff that makes me think smartwatches can be a lifesaver in some cases. Didn't even know that the Samsung watches had such features, only just recently started using my Garmin Vivoactive again, tempted to get something else. What did the watch do when contacting the emergency contact? Is there some sort of a message that they are sent with specific information? Sounds like something from a futuristic movie tbh

 

 

 

So according to him, his phone detected the crash and a pop up appeared on his watch allowing him to call our mom.

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15 minutes ago, Sorenson said:

So according to him, his phone detected the crash and a pop up appeared on his watch allowing him to call our mom.

Ahh so not fully autonomous but still really cool, I can imagine it being easier to tap a button on your wrist than than trying to reach for your phone if you end up in a crash since a lot less hand movement is required. Hope he's alright

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18 hours ago, PixelDust said:

For the record I am not American and have very little knowledge on anything having to do with the FDA and how they function, I just thought it was an interesting thing to point out.

Oh it certainly is. Jet_ski and my chat about FDA approval/clearance is more a side bit of information. the FDA classifies the Apple Watch app as a class 2 medical device, which from my very limited understanding puts it in the realm of a home thermometer or bathroom scale. These are not professional diagnostic tools, but they are valuble sources of medical data to individuals and can be of assistance to doctors (we've seen the value of home thermometers this past year as catching early symptoms of the pandemic, for example). So, while a fitbit or apple watch doesn't replace a doctor and their instruments, the claim by the makers, and backed by the article you shared, is that they do provide valuble health data.

So certainly a good thing!

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On 6/3/2021 at 1:45 AM, RejZoR said:

Still waiting to even get any of the functionality on my Apple Watch 5. Which is really annoying and not a single person could tell me who or what is the reason for this "blocking". Is it my country laws or is it Apple? I have no clue. I just know I have an expensive gadget that should have all these awesome, sometimes life saving features that simply refuse to work. And it's really annoying. It'll soon be 2 years after launch of AW5 and still nothing if you don't live in US? Ugh!?

It's down to your country. Apple has to get approval from local regulators for some health features, and those take time. Even in Canada we had to wait several months after the US before we could use ECG on the Apple Watch.

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On 6/3/2021 at 7:27 AM, Jet_ski said:

FDA Cleared and FDA Approved are not the same. I see this mistake in a lot of places. Specially from merchants and OEMs trying to mislead consumers into thinking a medical device or product is effective.

 

FDA Approved means the FDA has overseen several double blind trials, inspected manufacturing facilities, and has found concrete evidence the medicine treats a condition or a device does a diagnosis or performs a task. It’s usually costs $1-2 billion to bring a new medicine to the market and get it approved by the FDA.

 

FDA Cleared means the FDA has not found a device or product to be harmful. It makes no claims about its effectiveness or accuracy.

 

There are many products like home laser hair removal kits that go for $500 that are FDA Cleared. It fools consumers into thinking this thing works. But they don’t. All the FDA found is that this device won’t cause a health problem. Another example is herbs and supplements. When an herb bottle says it’s FDA Cleared it only means the contents have not been found to be poisonous or carcinogenic.

 

I’ve read that Apple in partnership with a lab has done their own studies on the effectiveness of the Apple Watch but that’s not the same as doing a study under the FDA oversight for medical device approval. That would cost Apple a bunch.

 

I like the Apple Watch but I wouldn’t recommend it as a medical device. Every small form factor medical device that I’ve seen is much trickier to operate than the professional one. For example those BP monitors that you wear around your wrist are extremely sensitive to the pose of your arm. If I made a device that told 0.1% of its users to get an EKG, I bet at least some of them will find a heart condition.

 

Unless the Fitbit and Apple Watch go through the FDA medical device approval process, we can’t know if they are any good.

Accuracy of diagnostic tools do not matter as much as time between screening. It is far better to have regular screening practices, especially in cardiology and oncology, rather than more powerful diagnostic tools. Theres little point in having amazing diagnostic capabilities if the patient isn't there. The popularity of the Apple Watch is great for detecting irregular heartbeats early, and stressing the candidate seek their medical professional. 

 

To use another example of Prostate Cancer - we have amazing tools, but often patients arrive symptomatic - this is far too late. If we can implement a system of check-up reminders with new digital technology, that would be amazing. Screening, not new diagnostic tools (which we already have sufficient capabilities for both cardiology and oncology) is more essential. Getting people out there for regular check-up is one of the biggest burden for modern medicine. Always encourage people to go out and see their doctor, it's what they get paid to do, even if you are feeling well. 

 

Moreover, monitoring of biomarkers, such as cardiac rhythm, over time is more productive than accuracy. Many biomarkers, such as CEA, PSA, Cardiac Rhythm, (as well as traditional serological markers) can vary significantly between individuals. If we have history for even a little bit of this data, over time, this can greatly benefit prognostic accuracy. 

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12 hours ago, RorzNZ said:

To use another example of Prostate Cancer ...... If we can implement a system of check-up reminders with new digital technology, that would be amazing.

What kind of prostate check-up system do you want to implant?😬😬😬

 

 

EDIT: I see now i misread "implement" as "implant" so my joke doesn't actually make sense, but oh well.

Edited by Video Beagle

🖥️ Motherboard: MSI A320M PRO-VH PLUS  ** Processor: AMD Ryzen 2600 3.4 GHz ** Video Card: Nvidia GeForce 1070 TI 8GB Zotac 1070ti 🖥️
🖥️ Memory: 32GB DDR4 2400  ** Power Supply: 650 Watts Power Supply Thermaltake +80 Bronze Thermaltake PSU 🖥️

🍎 2012 iMac i7 27";  2007 MBP 2.2 GHZ; Power Mac G5 Dual 2GHZ; B&W G3; Quadra 650; Mac SE 🍎

🍎 iPad Air2; iPhone SE 2020; iPhone 5s; AppleTV 4k 🍎

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Posted

I recommend everyone watch this video before rushing out and buying an Apple watch. 

 

 

 

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