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

[Denmac1]

BS....one lead ekg is not accurate...we need 12 ekg to get very accurate heart status.
EDIT: MUAHAHA. If you got that A.fib...or v.fib...you wouldn't depend on that. That watch might say.. "you're normal..there is nothing wrong you." You get that Pulmonary Embolism...you wouldn't be suing the company because you would be dead.

I have had A-Fib. First time in ER was pretty scary, especially when you see the 'red cart' next to you. I have been fortunate to this point that within 6 months, I had a self conversion back to normal sinus rhythm. A-Fib is a serious problem for millions of people and not to be taken lightly. I actually walked into ER with a heart rate of 158 and I had no symptoms whatsoever.
The last three EKG's that I have had (at an accredited hospital) used less that 12 leads and was actually only four.
Technology increases at a amazing rate and I welcome advances such as this. This type of diagnosis is new and will improve over time. The ability for people to begin to have the ability to monitor their own health becomes stronger every day.
In your statement of a 'Pulmonary Embolism', that is generally cause by a clot going into the lungs and causing heart distress.
The main concern of A-Fib is that the blood will pool in the ventricle that would cause a clot going to the brain and causing a stroke. Either way, for many people, it's not humorous.

 

[CFreymarc]

I have done several medical device designs. From that, I really question the reliability of taking an ECG from any of the human bodies four limb ends.

As the pressure wave of a heart beat travels from the cardiac chambers, the R-wave (that big spike you see in an ECG) is really diminished after going through all the continually smaller blood vessels making to the wrist. This is classic fluid dynamics.

I'm sure with a press announcement like this, there will be third party petitions questioning the reliability of such a device making claims to read an ECG at the end of a human limb. If they are making any waveform reconstruction claims, the FDA will really put the screws to them as that can introduce a lot of false interpretations.

Also, whenever you go from "number to waveform", the FDA gets really inquisitive looking at the accuracy of the readings. My guess is the FDA will not approve this device and it will be sold overseas in places where claims are not so questioned.

 

[pat500000]

I have had A-Fib. First time in ER was pretty scary, especially when you see the 'red cart' next to you. I have been fortunate to this point that within 6 months, I had a self conversion back to normal sinus rhythm. A-Fib is a serious problem for millions of people and not to be taken lightly. I actually walked into ER with a heart rate of 158 and I had no symptoms whatsoever.
The last three EKG's that I have had (at an accredited hospital) used less that 12 leads and was actually only four.
Technology increases at a amazing rate and I welcome advances such as this. This type of diagnosis is new and will improve over time. The ability for people to begin to have the ability to monitor their own health becomes stronger every day.
In your statement of a 'Pulmonary Embolism', that is generally cause by a clot going into the lungs and causing heart distress.
The main concern of A-Fib is that the blood will pool in the ventricle that would cause a clot going to the brain and causing a stroke. Either way, for many people, it's not humorous.

Yes...of course it's risk for PE. Of course it's not funny...but depending on toys like apple watch to monitor your heart is NOT SUITABLE (IMO at least). I was just mocking the product because in all seriousness...the best way to prevent further deterioration of the heart is actually get checked by doctors routinely and taking medications (as long as it's appropriate). If you don't mind me asking...were you on Amiderone? Yeah..I've seen people asymptomatic with high HR.

Usually people who who heart problem should try not to do strenuous workout.

 

[iLondoner]

...but depending on toys like apple watch to monitor your heart is NOT SUITABLE (IMO at least)..

There seems to be a misunderstanding over how this works. The current AliveCor Mobile ECG that my wife uses is an independent ECG pad that communicates with the iPhone using Bluetooth, see http://www.amazon.co.uk/AliveCor-Mobile-ECG-from/dp/B01A4W8AUK

My wife has the optional iPhone 6 case that allows the pad to be clipped onto the phone, see http://www.amazon.com/AliveCor-Mobile-ECG-iPhone-Case/dp/B01A7VVQV8

The new Watch strap-based unit uses the Watch merely as an interface to initiate a fresh reading and to allow voice annotations. As with many Watch apps, you need to have the iPhone around as the app actually runs on the iPhone. The sensors are embedded in the strap and these communicate with the iPhone over Bluetooth as with the current device. The Apple Watch isn't involved in anything clever here, it's just a display/interface device, the real work is being done by the sensors in the strap and the iPhone App software.

Personally I don't see any advantage in using the Watch strap device over the current one, but I nevertheless welcome the innovation. But the point is, the existing mobile ECG device is already FDA approved so I expect the new strap-based device to also be approved.

The market for these types of devices is immense. It's reckoned there's somewhere between 3 and 6 MILLION Afib suffers in just the USA, see http://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm

My wife wore a 2-channel Holter monitor for 24 hours and as sod's law has it, nothing untoward was picked up. The AliveCor unit is with her 24/7 and enables her to check she's in sinus rhythm at any time of the day or night.

 

[Thai]

There seems to be a misunderstanding over how this works. The current AliveCor Mobile ECG that my wife uses is an independent ECG pad that communicates with the iPhone using Bluetooth, see http://www.amazon.co.uk/AliveCor-Mobile-ECG-from/dp/B01A4W8AUK

My wife has the optional iPhone 6 case that allows the pad to be clipped onto the phone, see http://www.amazon.com/AliveCor-Mobile-ECG-iPhone-Case/dp/B01A7VVQV8

The new Watch strap-based unit uses the Watch merely as an interface to initiate a fresh reading and to allow voice annotations. As with many Watch apps, you need to have the iPhone around as the app actually runs on the iPhone. The sensors are embedded in the strap and these communicate with the iPhone over Bluetooth as with the current device. The Apple Watch isn't involved in anything clever here, it's just a display/interface device, the real work is being done by the sensors in the strap and the iPhone App software.

Personally I don't see any advantage in using the Watch strap device over the current one, but I nevertheless welcome the innovation. But the point is, the existing mobile ECG device is already FDA approved so I expect the new strap-based device to also be approved.

The market for these types of devices is immense. It's reckoned there's somewhere between 3 and 6 MILLION Afib suffers in just the USA, see http://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm

My wife wore a 2-channel Holter monitor for 24 hours and as sod's law has it, nothing untoward was picked up. The AliveCor unit is with her 24/7 and enables her to check she's in sinus rhythm at any time of the day or night.

Doesn't it communicate with Apple Watch via ultrasonic waves? These things emit a high pitched sound that’s more or less outside the range of what humans can hear and the smartphone/watch listens using the microphone and translates into an EKG.

 

[iLondoner]

Apologies, yes, you are right, I didn't realise that both the existing Mobile ECG and the strap-based device use ultrasonics, per explanation at http://9to5mac.com/2015/10/16/alivecor-apple-watch-ecg/

This explains why, although my wife's Mobile ECG is clipped to the back of her iPhone I can initiate the app on my iPhone and do a recording using her sensors...

The point I was making in the post above is that the Watch isn't really doing much here, all the clever technology is in the sensor and the app running on the iPhone. The video on the above link shows a small 15-second sample being recorded, in reality you would probably go for the default 30 seconds or even 60 seconds.

With the existing Mobile ECG solution, the ECG is displayed on the iPhone in real time, so if you are watching the output and can see you're in sinus rhythm with good P-wave you can terminate the sample before it finishes and avoid saving it in memory.

I don't think you can do that with the strap-based device, the entire sample has to be recorded and then passed to the iPhone app for analysis before the results can be shown. The video demonstrates the ECG being displayed on the Watch—I believe this can only be done if the iPhone is in close vicinity as the analysis is carried out there, not in the Watch.

The Watch is a pretty small window to be looking at an ECG and if I had any concerns about the results I would be viewing them on the larger screen of the iPhone.

 

[Thai]

Apologies, yes, you are right, I didn't realise that both the existing Mobile ECG and the strap-based device use ultrasonics, per explanation at http://9to5mac.com/2015/10/16/alivecor-apple-watch-ecg/

This explains why, although my wife's Mobile ECG is clipped to the back of her iPhone I can initiate the app on my iPhone and do a recording using her sensors...

The point I was making in the post above is that the Watch isn't really doing much here, all the clever technology is in the sensor and the app running on the iPhone. The video on the above link shows the ECG being displayed on the Watch—I believe this can only be done if the iPhone is in close vicinity as the analysis is carried out there, not in the Watch. The Watch is a pretty small window to be looking at an ECG and if I had any concerns about the results I would be viewing them on the larger screen of the iPhone.

I could be wrong...but the sensor communicates with the WATCH (not the iPhone) via ultrasound. It duplicates the data on iPhone and then you can send it off to AliveCOR for reading via iPhone.

You can use the crown to scroll thru the ECG.

The question i have is...does the sensor on band need battery?? If so, what type?
[doublepost=1458225246][/doublepost]

I have done several medical device designs. From that, I really question the reliability of taking an ECG from any of the human bodies four limb ends.

As the pressure wave of a heart beat travels from the cardiac chambers, the R-wave (that big spike you see in an ECG) is really diminished after going through all the continually smaller blood vessels making to the wrist. This is classic fluid dynamics.

I'm sure with a press announcement like this, there will be third party petitions questioning the reliability of such a device making claims to read an ECG at the end of a human limb. If they are making any waveform reconstruction claims, the FDA will really put the screws to them as that can introduce a lot of false interpretations.

Also, whenever you go from "number to waveform", the FDA gets really inquisitive looking at the accuracy of the readings. My guess is the FDA will not approve this device and it will be sold overseas in places where claims are not so questioned.

But their phone cases that does the same thing has ALREADY been approved by FDA via PMA (more strict than 510k).
[doublepost=1458225481][/doublepost]

BS....one lead ekg is not accurate...we need 12 ekg to get very accurate heart status.
EDIT: MUAHAHA. If you got that A.fib...or v.fib...you wouldn't depend on that. That watch might say.. "you're normal..there is nothing wrong you." You get that Pulmonary Embolism...you wouldn't be suing the company because you would be dead.

One lead ECG...this gives you a rhythm strip, right? This is NOT about diagnosing ST-elevation MI nor PE. This is about HELPING to diagnose conduction issues of the heart. It is especially good for those with PAROXYSMAL arrhythmias where their rhythm may be normal at doctor's visits but get irregular at other times.

Even with a 12 lead ECG, you cannot diagnose PE! S1Q3T3 crap is almost never seen.

 

[Picka]

As someone who had heart surgery at 17, I am glad about this technology.
Guys, we're witnessing a medical revolution.

A heart rate monitor? We've had them for a while

 

[Dave00]

In your opinion... My wife has AFib and is signed up to a medical trial in the UK led by two of the UK's top EPs (electro physiologists).

She has the current AliveCor device which clips into a specially-designed iPhone 6 case and is able to take and annotate ECGs at will storing the results on the iPhone (Bluetooth connection). The EPs are delighted she has the AliveCor device and can instantly tell if she is in sinus rhythm. In fact she can now intepret the results quite well, looking for rhythm and P-wave.

It's not my opinion. The way a rhythm is determined is by measuring electrical activity from points at different physical orientations from the heart. Unless there's a another lead somewhere and there's some connection between those two leads, you can't determine the electrical impulse. You MIGHT be able to determine rhythm from the pattern of the heart rate (if irregular, it might be a-fib) but given the poor ability of wrist devices to consistently detect heartbeats (multiple studies) even that is a stretch.
If it were this easy to monitor heart rhythm, we'd have no need for event monitors and holter monitors, which are considerably more cumbersome than a watch. If an electrophysiologist were supporting the use of this device, I'd take a hard look at financial conflicts.
[doublepost=1458228427][/doublepost]

I could be wrong...but the sensor communicates with the WATCH (not the iPhone) via ultrasound. It duplicates the data on iPhone and then you can send it off to AliveCOR for reading via iPhone.

You can use the crown to scroll thru the ECG.

The question i have is...does the sensor on band need battery?? If so, what type?
[doublepost=1458225246][/doublepost]

But their phone cases that does the same thing has ALREADY been approved by FDA via PMA (more strict than 510k).
[doublepost=1458225481][/doublepost]

One lead ECG...this gives you a rhythm strip, right? This is NOT about diagnosing ST-elevation MI nor PE. This is about HELPING to diagnose conduction issues of the heart. It is especially good for those with PAROXYSMAL arrhythmias where their rhythm may be normal at doctor's visits but get irregular at other times.

Even with a 12 lead ECG, you cannot diagnose PE! S1Q3T3 crap is almost never seen.

Here's the thing. One-lead EKG? Where have you seen that? Tell me how it's physically possible, when the rhythm is generated by comparing the electrical signal at different sites?

 

[Thai]

It's not my opinion. The way a rhythm is determined is by measuring electrical activity from points at different physical orientations from the heart. Unless there's a another lead somewhere and there's some connection between those two leads, you can't determine the electrical impulse. You MIGHT be able to determine rhythm from the pattern of the heart rate (if irregular, it might be a-fib) but given the poor ability of wrist devices to consistently detect heartbeats (multiple studies) even that is a stretch.
If it were this easy to monitor heart rhythm, we'd have no need for event monitors and holter monitors, which are considerably more cumbersome than a watch. If an electrophysiologist were supporting the use of this device, I'd take a hard look at financial conflicts.
[doublepost=1458228427][/doublepost]
Here's the thing. One-lead EKG? Where have you seen that? Tell me how it's physically possible, when the rhythm is generated by comparing the electrical signal at different sites?

You're missing the point of such devices. This does NOT replace Holter or EMs. It does NOT replace 12-lead ECG. This yet another CONVENIENT tool that patients (and indirectly doctors) use to diagnose a conduction issue or evaluate effectiveness of treatment, especially in someone who has paroxysmal conduction issues.

It is like camera analogy...of course Canon 5D takes better pictures than my iPhone. But my iPhone is always with me to take impromptu pics. The best camera is the one that you have with you, right?

Same for AliveCor phone case and Watch band. It is using (via add-on) what you ALREADY carry with you every minute of the day. Even Holter can be difficult if patients have arrhythmias beyond the monitoring period.

And given that their phone case has gotten FDA approval via PMA (strict testings), then these portable devices are ADEQUATE medical grade devices. There is no argument on this. The Watch band is using the same tech as the AliveCor phone cases and thus should pass 510k clearance easily. And yes, this is medical grade.

 

[Gizmotoy]

It's not my opinion. The way a rhythm is determined is by measuring electrical activity from points at different physical orientations from the heart. Unless there's a another lead somewhere and there's some connection between those two leads, you can't determine the electrical impulse. You MIGHT be able to determine rhythm from the pattern of the heart rate (if irregular, it might be a-fib) but given the poor ability of wrist devices to consistently detect heartbeats (multiple studies) even that is a stretch.
If it were this easy to monitor heart rhythm, we'd have no need for event monitors and holter monitors, which are considerably more cumbersome than a watch. If an electrophysiologist were supporting the use of this device, I'd take a hard look at financial conflicts.
[doublepost=1458228427][/doublepost]
Here's the thing. One-lead EKG? Where have you seen that? Tell me how it's physically possible, when the rhythm is generated by comparing the electrical signal at different sites?

A "one-lead" ECG has two terminals. You need one on either side of the body for it to work. In the standalone version you rest both of your hands on the devices. In this band version there's a terminal on the inside of the band, and you touch the terminal on the outside of the band with your other hand.

 

[Thai]

A "one-lead" ECG has two terminals. You need one on either side of the body for it to work. In the standalone version you rest both of your hands on the devices. In this band version there's a terminal on the inside of the band, and you touch the terminal on the outside of the band with your other hand.

Exactly. The one lead ECG is nothing new. What is new is the awesome portability because of the convenient add-on to devices that you already carry.

 

[Dave00]

You do realize even using a 3 or 4 lead ECG machine, your basic rhythm interpretation is read using 1 lead (i.e. Lead II). The watch uses two contact points one on each side of the body for it's reading. You can do the same using got the LA, and RA leads on a standard LP15, which will give you a Lead I reading. If you don't believe that look up Einthoven's triangle.

How is lead II generated, though? You can't just connect one lead and determine anything at all. If there's a second contact on the other side of the body, it's not referenced anywhere in this article. In fact, other articles seem to indicate that both contact points are in the watch wrist band. Even with sensors on opposite sides, I'm not sure how you would determine anything without those two leads being physically connected. Einthoven's original EKG machine required both leads be connected, as does every Holter/Event monitor I'm aware of. I think this is bunk.

 

[0958400]

Finally! Congratulations to the company, I hope you'll sell them soon - internationally. 8)
So the wristbands are the Apps of the Apple Watch?

 

[Dave00]

A "one-lead" ECG has two terminals. You need one on either side of the body for it to work. In the standalone version you rest both of your hands on the devices. In this band version there's a terminal on the inside of the band, and you touch the terminal on the outside of the band with your other hand.

Okay, THIS makes more sense. You have to have sensors with different orientations to the heart. So if the second sensor is using the finger from your non-watch hand and making a circuit, it could conceivably measure an ECG rhythm (though likely with a lot of noise). Even the computer analysis on a standard heart monitor (with leads right next to the heart) is fraught with misinterpretations; I would be wary of relying on the monitor reliably interpreting anything given the substantial noise. Guaranteed someone's going to have a missed arrhythmia on one of these and sue. And probably win.

 

[Thai]

Okay, THIS makes more sense. You have to have sensors with different orientations to the heart. So if the second sensor is using the finger from your non-watch hand and making a circuit, it could conceivably measure an ECG rhythm (though likely with a lot of noise). Even the computer analysis on a standard heart monitor (with leads right next to the heart) is fraught with misinterpretations; I would be wary of relying on the monitor reliably interpreting anything given the substantial noise. Guaranteed someone's going to have a missed arrhythmia on one of these and sue. And probably win.

But remember, this band has only 3 readings (i think): normal, too noisy, and probable afib. I am sure that the thresholds are set low. So, it is not like a regular ECG machine interpreting blocks, conduction delays, etc..

 

[pat500000]

I could be wrong...but the sensor communicates with the WATCH (not the iPhone) via ultrasound. It duplicates the data on iPhone and then you can send it off to AliveCOR for reading via iPhone.

You can use the crown to scroll thru the ECG.

The question i have is...does the sensor on band need battery?? If so, what type?
[doublepost=1458225246][/doublepost]

But their phone cases that does the same thing has ALREADY been approved by FDA via PMA (more strict than 510k).
[doublepost=1458225481][/doublepost]

One lead ECG...this gives you a rhythm strip, right? This is NOT about diagnosing ST-elevation MI nor PE. This is about HELPING to diagnose conduction issues of the heart. It is especially good for those with PAROXYSMAL arrhythmias where their rhythm may be normal at doctor's visits but get irregular at other times.

Even with a 12 lead ECG, you cannot diagnose PE! S1Q3T3 crap is almost never seen.

I didn't say you can be diagnosed with PE.

 

[Thai]

So, does the sensor on the watch band need battery?????

 

[iLondoner]

I could be wrong...but the sensor communicates with the WATCH (not the iPhone) via ultrasound. It duplicates the data on iPhone and then you can send it off to AliveCOR for reading via iPhone.

You can use the crown to scroll thru the ECG.

The question i have is...does the sensor on band need battery??

Yes you are right, it communicates with the Watch (can be used without the iPhone being present) and then passes the raw data to the phone. I believe when it's displaying the ECG data on the Watch that the graphics are coming from the iPhone app.

Current Mobile ECG requires coin-type battery.

 

[Thai]

Yes you are right, it communicates with the Watch (can be used without the iPhone being present) and then passes the raw data to the phone. I believe when it's displaying the ECG data on the Watch that the graphics are coming from the iPhone app.

Current Mobile ECG requires coin-type battery.

Next question...is the sensor waterproof??

 

[jonnysods]

Now the tech revolution begins for wearables. Can't wait to get my hands on the AW2.

I hope it comes out Monday!

 

[mfm77]

If a company can do this with EKG readings, could another company introduce a GPS smart band? I'm a marathon runner who would love to buy an Apple Watch, but the lack of dedicated GPS has held me back from purchasing one. I do run with my iPhone, but even so, I've heard the GPS via Bluetooth results in inaccurate distances. I'm wondering if a GPS smart band would be possible.

 

[Thai]

If a company can do this with EKG readings, could another company introduce a GPS smart band? I'm a marathon runner who would love to buy an Apple Watch, but the lack of dedicated GPS has held me back from purchasing one. I do run with my iPhone, but even so, I've heard the GPS via Bluetooth results in inaccurate distances. I'm wondering if a GPS smart band would be possible.

I am kinda expecting Apple to introduced new bands with new sensors and capability (GPS, battery etc) next week. Hoping....

 

[CFreymarc]

If a company can do this with EKG readings, could another company introduce a GPS smart band? I'm a marathon runner who would love to buy an Apple Watch, but the lack of dedicated GPS has held me back from purchasing one. I do run with my iPhone, but even so, I've heard the GPS via Bluetooth results in inaccurate distances. I'm wondering if a GPS smart band would be possible.

I can tell your right now, many in the medical device design community is seriously questioning the validity of this device. There are many open news groups on the net dedicated to medical instrument design. Start searching to dive in deeper.

Doing an ECG from the wrist is very difficult as the R-wave (the spike in the heartbeat waveform) is attenuated as it reaches the end of the limbs. If they are doing any signal reconstruction, I bet there will be a lot more third party inqiries of this FDA approval.

 

[Thai]

I can tell your right now, many in the medical device design community is seriously questioning the validity of this device. There are many open news groups on the net dedicated to medical instrument design. Start searching to dive in deeper.

Doing an ECG from the wrist is very difficult as the R-wave (the spike in the heartbeat waveform) is attenuated as it reaches the end of the limbs. If they are doing any signal reconstruction, I bet there will be a lot more third party inqiries of this FDA approval.

Show me where there is these "questioning"?? Medical design community? Yeah, because they are jealous maybe that someone thought of this before them?

AliveCor phone case pads have been approved by FDA via PMA route for a while now. This AW band method is nothing new...just now involves the AW.