AliveCor Announces Apple Watch 'Kardia Band' for Medical Grade EKG Analysis

[s2mikey]

No, no, no, no, no. This is so fantastically wrong. I can't believe this got approval.

You cannot do an EKG/ECG from one lead. It's not an EKG.

Second, I can't think of a way you would be able to determine rhythm from one lead. The physics aren't there. You need at least 3 leads just to do telemetry, which is what you see when someone is on a heart monitor at the hospital. It might be able to determine whether a rate is irregular, but that's about it.

This has fraud written all over it. I wouldn't rely on a watch to determine heart rhythm. Period.

To the moderators, I would remove what appears to be an endorsement of a product that basically has no possibility of actually working and has potential to cause harm.

Sincerely,
D. Sacco, MD

Im not a doctor and I dont play one on TV either. Sorry, had to get that line in there.

But, it'll be a cold day in the depths of hell when a watch band determines the status of electrical activity in my heart being OK or bad. No way. How do they test this out? Wait for people to hopefully have strokes and see if the watch picks up on it? Do tests on willing subjects that sign a waiver that says they dont mind if blood flow to their brain is stopped for a while?

I wonder too about legal ramifications that will undoubtedly stem from cases where the watch did NOT pick up on a heart problem and that person died because they didnt go get help. ChaaaChinggg $$$$$

Or, how about false positives? Sending people to ERs for what amounts to nothing.

I dunno.... this whole thng seems extremely suspect to me.

 

[JeffyTheQuik]

I love it! We're getting closer and closer to "She's fallen, and she can't get up!" kind of technology to make all of our lives better!

 

[ohio.emt]

Im not a doctor and I dont play one on TV either. Sorry, had to get that line in there.

But, it'll be a cold day in the depths of hell when a watch band determines the status of electrical activity in my heart being OK or bad. No way. How do they test this out? Wait for people to hopefully have strokes and see if the watch picks up on it? Do tests on willing subjects that sign a waiver that says they dont mind if blood flow to their brain is stopped for a while?

I wonder too about legal ramifications that will undoubtedly stem from cases where the watch did NOT pick up on a heart problem and that person died because they didnt go get help. ChaaaChinggg $$$$$

Or, how about false positives? Sending people to ERs for what amounts to nothing.

I dunno.... this whole thng seems extremely suspect to me.

Easy to test you just have a patient with A-fib wear the band, and a traditional Holter monitor and compare the results. Also it doesn't identify strokes just a heart rhythm that can lead to clots, which can lead to an MI,CVA, or PE. The algorithms that the device uses are probably based on the ones currently used in 12-lead ECG, but modified to account for movement, one having one lead etc...

 

[mrgraff]

I'll admit I have no idea what I'm talking about. But, it seems to be that if I was in a position were someone needed to analyze my current EKG, I wouldn't have the capacity to use my Apple Watch and take the reading by myself.

 

[applebreed]

More of a general, but related, question: what Apple Watch functions and/or related products right now are available that do monitoring of any sort while the Watch is charging at night? I think I heard/read some vague thing about sleep cycle monitoring while charging happens but does that actually exist yet?

 

[mdriftmeyer]

I am surprised they would invest in this tech seeing as stuff like this will be integrated into the Apple Watch brands. If you think this stuff won't be added via the sensors and moreso along the bands something for upcoming model refreshes I have to wonder about people.
[doublepost=1458148692][/doublepost]

I'll admit I have no idea what I'm talking about. But, it seems to be that if I was in a position were someone needed to analyze my current EKG, I wouldn't have the capacity to use my Apple Watch and take the reading by myself.

Consider it a predictive model device where your records are being managed remotely and you get contacted by your physician that your ECG readings are consistent in irregularities and we recommend you come in before you have a heart attack.

 

[name99]

This can't possibly be accurate. My dad had a medical emergency last week. The EMTs started out with a four-lead ECG. They then switched to a 12-lead. The pads were dispersed all over his torso. The electrical signals travel from right to left across the heart. How could a wrist monitor (which might be on either wrist) perform the same function?

It doesn't have to perform the exact same function to be useful. I know someone who suffers from heart arrhythmia maybe once a month. The doctors have no idea quite why because they can't reproduce it. If she could capture a snapshot of the EKG signal when it happens, especially three or four snapshots, that's useful diagnostic info even if it's not as much detail as a full EKG.

This sort of immediate "I'm having an episode" monitoring seems to be the target market for this device.

 

[BruceEBonus]

Unbelievable. AFib. Normal Sinus and full QRS reading from a watch strap? Good luck with that, mate!

 

[name99]

More of a general, but related, question: what Apple Watch functions and/or related products right now are available that do monitoring of any sort while the Watch is charging at night? I think I heard/read some vague thing about sleep cycle monitoring while charging happens but does that actually exist yet?

Sleep++ https://itunes.apple.com/us/app/sleep++/id1038440371?mt=8
will monitor sleep (and if used properly as the app tells you, will use very little power while doing so). The app is still in early stages so it tracks sleep motion but not heart rate (which could give a more comprehensive sleep picture), likewise the stats are still not as comprehensive as one would like.
Some of the limitations in the app are clearly due to Apple restrictions on an app running in the background (to save power) and I assume over the next few years they will gradually go away.

Point is, you can now do this on your watch; it works reasonably well, but it's not (yet) as slick or automated as on a dedicated device (or on a Pebble). I expect it to get a lot better this time next year through some combination of Apple opening up APIs and/or building the functionality directly into the OS (now that third parties have shown it can be done at very low power usage).

 

[StyxMaker]

Im not a doctor and I dont play one on TV either. Sorry, had to get that line in there.

But, it'll be a cold day in the depths of hell when a watch band determines the status of electrical activity in my heart being OK or bad. No way. How do they test this out? Wait for people to hopefully have strokes and see if the watch picks up on it? Do tests on willing subjects that sign a waiver that says they dont mind if blood flow to their brain is stopped for a while?

I wonder too about legal ramifications that will undoubtedly stem from cases where the watch did NOT pick up on a heart problem and that person died because they didnt go get help. ChaaaChinggg $$$$$

Or, how about false positives? Sending people to ERs for what amounts to nothing.

I dunno.... this whole thng seems extremely suspect to me.

This device, and others like it, are not intended to monitor your heart and diagnose problems. They are, primarily, intended for people who have already been diagnosed as having specific heart problems. It will allow them to check their heart rhythms, when they feel a need to, and report data to their doctor.

 

[Sleepyshibe]

This can't possibly be accurate. My dad had a medical emergency last week. The EMTs started out with a four-lead ECG. They then switched to a 12-lead. The pads were dispersed all over his torso. The electrical signals travel from right to left across the heart. How could a wrist monitor (which might be on either wrist) perform the same function?

That's the thing, it can't be. Those 12 leads pick up the heart's minute electrical signals from 12 different angles. When someone comes in with a heart attack, medical professionals can tell where the occlusion is causing the ischemia on the heart. Similarly, to interpret if someone has an arrhythmia like A-fib, heart block, etc, you need a 12 lead because it's much more sensitive. Even 5 lead monitors they typically have ICU patients on 24/7 are not conclusive enough to diagnose.

This device sits on your wrist, far away from the heart, and it's impossible with current technology to produce any significant diagnostic information. Even if the technology were available, it would have been seen in the medical field first because something this uninvasive and simple to use would be jumped on in a second.

Sorry, but it's a gimmick and a novelty. "Medical Grade" is just a marketing strategy to get you to buy into it.

 

[co.ag.2005]

Sleep++ https://itunes.apple.com/us/app/sleep++/id1038440371?mt=8
will monitor sleep (and if used properly as the app tells you, will use very little power while doing so). The app is still in early stages so it tracks sleep motion but not heart rate (which could give a more comprehensive sleep picture), likewise the stats are still not as comprehensive as one would like.
Some of the limitations in the app are clearly due to Apple restrictions on an app running in the background (to save power) and I assume over the next few years they will gradually go away.

Point is, you can now do this on your watch; it works reasonably well, but it's not (yet) as slick or automated as on a dedicated device (or on a Pebble). I expect it to get a lot better this time next year through some combination of Apple opening up APIs and/or building the functionality directly into the OS (now that third parties have shown it can be done at very low power usage).

This something I've been wanting ever since moving on from the FitBit Charge HR. Does it work pretty well? (despite the lack of HR support)

 

[stanman64]

I don't see insurance covering something like this, and I don't see a lot of patients dropping their own $100 on one of these, especially if they are elderly. And even if they do want to use it, they would have to get their doctor on board if they aren't already. Best case I could see this being beneficial: Someone who must have frequent check-ups, and perhaps this would save them the trouble of making so many trips.

With that being said, I think this is a great product and a glimpse of the future. However, right now, I think it is a very niche product. Would love to see it pick up steam though.

 

[StyxMaker]

More of a general, but related, question: what Apple Watch functions and/or related products right now are available that do monitoring of any sort while the Watch is charging at night? I think I heard/read some vague thing about sleep cycle monitoring while charging happens but does that actually exist yet?

I use a program that monitors my heart and body motions while I sleep. I put the watch on the charger about an hour before I go to bed, then put it back on, fully charged, when I'm ready to go to sleep. The watch battery easily lasts until the next evening.

 

[StyxMaker]

This something I've been wanting ever since moving on from the FitBit Charge HR. Does it work pretty well? (minus the lack of HR)

I use the HeartWatch app, check it out also.

 

[co.ag.2005]

oops, you ninja posted

thanks for the info

 

[StyxMaker]

oops, you ninja posted

thanks for the info

HeartWatch, I should have included that.

 

[Mac 128]

Probably uses Bluetooth LE, also doubt that Bluetooth is actively transmitting until you place you finger on the outside electrode or it receives a signal from the watch.

Fair enough, but even BT LE seems like a substantial power drain coming from a watch battery. But then I don't really know ... I guess my car remote lasts about a year, but I'm not using it more than a couple of times a day on average, and it has two such batteries. Then again, it also has to transmit from a much further distance.

Pretty cool regardless ...

I'm sure Apple is already planning similar technology, but which also recharges at the same time the watch does. If they introduced these kinds of watch bands at the March event, that might be worth tuning in for after all ...

 

[neuropsychguy]

Well, the title of the article specifically says "medical grade EKG analysis". Can someone provide the hierarchy of what is casual analysis versus medical grade and those in between? The title sounds like they are intimating the highest standard.

edit: word choice

There's medical grade and then there's medical grade. I'll make the distinction. Medical grade doesn't really mean anything, or at least isn't a standard. Medical grade can mean it is similar to devices or materials used in medical assessment and treatment or it can mean that it actually is used for assessment and care (or could be).

I work in the medial field (clinical research). There are a number of devices that provide medical grade results (e.g., home FDA-approved blood pressure monitors) but are not robust and accurate enough for reimbursed clinical use (at least not in the perception of providers).

This ECG wristband might be accurate (and thus "medical grade" - again, that doesn't really mean anything) as a screening device but you can bet that if it gets classified by the FDA then they will require a statement that it's not to be used for medical care. Any questions or concerns should be discussed with a board certified professional. It's like with medical exams. A physician could do a cursory but grossly accurate physical or you could go in for a full lab workup, stress test, *scopies, MRI, CT, etc. Both are medical grade but one is clearly better than the other (and much more expensive).

This will be good for people who have known heart issues (or who are at risk) who want to screen for abnormalities regularly and then go in for a comprehensive test if there are issues (and maybe if there aren't issues). Also, even if quality is inferior to 4+ lead ECGs, most people don't go around with any sort of ECG monitoring them 24/7. There have been many times that people have had issues that don't arise on formal monitoring (ECG, EEG, etc.) because the events happen sporadically.

 

[iLondoner]

Unbelievable. AFib. Normal Sinus and full QRS reading from a watch strap? Good luck with that, mate!

No, not unbelievable, it's true. I do wish that people would do some basic research like actually looking at the company's website before commenting.

http://www.alivetec.com/alivecor-heart-monitor/

 

[name99]

This something I've been wanting ever since moving on from the FitBit Charge HR. Does it work pretty well? (despite the lack of HR support)

It depends what you are after. Look at the screen shots. It records the period you are asleep, and the fraction of that time that you are restless. (And stores the results in Healthkit for other apps to use.) But it requires manual curation (doesn't automatically start/stop), and the analysis of the data is very primitive right now (though I think there's a chance that in time that will improve).
There IS (IMHO) a lot of interesting data that can be mined from what is recorded --- things like how long it takes you to fall asleep, how long your average "deep sleep" periods are, how often before you get up to pee, etc --- and of course monitoring how these change over time. But all that is hope for the future, it's not there right now.

I think it's worth the $1.99, but you might not --- read all the info before you buy it, so you can't claim you were misled.
[doublepost=1458153598][/doublepost]

It depends what you are after. Look at the screen shots. It records the period you are asleep, and the fraction of that time that you are restless. (And stores the results in Healthkit for other apps to use.) But it requires manual curation (doesn't automatically start/stop), and the analysis of the data is very primitive right now (though I think there's a chance that in time that will improve).
There IS (IMHO) a lot of interesting data that can be mined from what is recorded --- things like how long it takes you to fall asleep, how long your average "deep sleep" periods are, how often before you get up to pee, etc --- and of course monitoring how these change over time. But all that is hope for the future, it's not there right now.

I think it's worth the $1.99, but you might not --- read all the info before you buy it, so you can't claim you were misled.

BTW HeartWatch does something different. What it does is display (in a very interesting way) how your heart rate changes over time (during a day, a week, a month, etc). It's an interesting app because it's a prime example of the value of having lots of sensors + apps dumping data into HealthKit. If you use Heartwatch by itself, the display is not that interesting. But if you've been using the Workout app on your watch to mark whenever you exercise or walk, and if you're Sleep++ to track when you're asleep, then HeartWatch now has quite a bit more information to structure what it is displaying.

 

[SirCheese]

It's probably accurate, just not as accurate as a medical grade EKG. If they're seeking FDA approval for it, they at least feel comfortable with its accuracy. No one would go through all the effort with that if they weren't at least in the ballpark.

It's not to replace official tests but could show if there might be a problem that should get checked out further.

will bring "the first medical-grade EKG band" to the Apple Watch

 

[name99]

I use a program that monitors my heart and body motions while I sleep. I put the watch on the charger about an hour before I go to bed, then put it back on, fully charged, when I'm ready to go to sleep. The watch battery easily lasts until the next evening.

If you put your watch into Do Not Disturb and Airplane modes (very easy to do using the Glance swiped from the bottom of the screen) it will use a ridiculously small amount of power (like 5% of battery or less) during the 8 hrs of sleep.

 

[StyxMaker]

If you put your watch into Do Not Disturb and Airplane modes (very easy to do using the Glance swiped from the bottom of the screen) it will use a ridiculously small amount of power (like 5% of battery or less) during the 8 hrs of sleep.

I already have all of my iOS devices go into do not disturb mod at night. I haven't tried using Airplane mode, but then I'm not having a problem with the watch's battery lasting all night and all day. I charged it between 11:00 and 12:00 last night and now, 11:46 AM, I have 81% battery power.

 

[kdarling]

Anyone know how it communicates with the Watch/iPhone? Bluetooth or wired via the watch strap?

Their iPhone / Android case model communicates to their app via ultrasound heard by the host device's microphone. Perhaps they use the same technique with the Apple Watch.

This can't possibly be accurate. My dad had a medical emergency last week. The EMTs started out with a four-lead ECG. They then switched to a 12-lead. The pads were dispersed all over his torso. The electrical signals travel from right to left across the heart. How could a wrist monitor (which might be on either wrist) perform the same function?

Best guess is that you have to touch it with your non-Watch-wearing hand. This provides the complete electrical path from the back of the band through your wrist, through your body, and back through your other hand.

Like in this flow diagram from Samsung's smartwatch health sensor platform which includes an ECG:

when will we have bands / built-in AW sensors that can take reliable EKGs straight from the wrist ?

They can do it now; you just have to touch it as shown above to form a complete path past your heart.