AliveCor 'Kardia Band' Medical Grade EKG Analyzer for Apple Watch Receives FDA Approval

[ipedro]

With the issues of speed, UI, battery and always online LTE connection now mostly resolved with Series 3, Apple is going to have to move into adding more health sensors to the Watch to drive new sales. I had mentioned that an EKG was the path of least resistance (Ha! a medical pun) and that blood sugar would be the holy grail that Apple is allegedly working on furiously to get accurate enough to ship.

Apple could easily build an EKG into the next AppleWatch. An EKG requires opposite parts of your body to come into contact with metal plates so that the time of travel of an electrical current can be measured. So unfortunately, it can't be a passive measurement like the existing sensors without wearing something on the other wrist. But it could it be as easy as building a metal ring around the screen and prompting users to measure an EKG if the standard heart rate sensor detects something suspicious — like is done with this third party sensor.

Alternatively, AirPods have potential to play a bigger role in Apple's current health and fitness direction. AirPods with health sensors could routinely and passively measure body temperature since they're in your ears but could contain also measure an EKG since they're on opposite sides of your body.

Overall, I like Apple's focus on health and fitness. Computers no longer have to compete on speed like they have for decades. Actually improving your life is both a noble goal and a competitive advantage.

 

[AppleInLVX]

I feel sorry for hypochondriacs. They're going to drive themselves bananas with this thing.

Not to mention drive themselves into the poorhouse with subscriptions and into the arms of people ready to exploit sensitive health data. You're more right than you know.

 

[tubuliferous]

I've heard of people who were denied health coverage because of the DNA sequencing

That statement is not entirely true if we're talking about the United States. The Genetic Information Nondiscrimination Act (GINA) makes it illegal (for now) in the US for insurance companies to deny coverage or raise rates for clients or potential clients based on genetic information. However, GINA does not cover disability insurance, long-term-care insurance, or life insurance. It's therefore possible that individuals in the US have already been denied health-related insurance based on genetic information. "Health coverage" usually implies traditional health insurance, though. It might seem like I'm being overly picky about the semantics of the statement, but this an important issue and an issue where the details are important.

 

[harrisondavies]

Immediately sold out on Amazon UK. Wow!

I’ve used the handheld device and it’s amazing.

 

[satchmo]

Cool tech, bad pricing on an application subscription. If you even read their website you will not get notifications if there's an issue without this subscription. To me that's a massive no no. Hey use the basic features for 200.00 but to actually get the information you'd need if there is an issue, PAY MORE! Hopefully this paves the way for other companies to come in and make something that isn't subscription based nonsense. Not to mention the band is a silicone grade, that's a no no for me as well. I have to have bands that are cloth material. I know I'm not the only one who has to have this.

Yeah I was thinking the barrier to entry should be much cheaper. I get the company needs to recoup their costs and make money. It just feel like they could make a boat load more if the band was like $99 and an accompanying $5 app.
It would be a no-brainer for many to drop $100.
Making it $200 plus $100/yr may turn some people off.
Also what important information is missing if you don't sign up annually?

 

[swingerofbirch]

I have the Kardia and it works really well. But I've noticed I get a lot of interference when using with my iPhone 7 but not iPhone 5s.

 

[hobocamp456]

All of these companies with their subscriptions can piss off

 

[mdmitchell]

Does anyone know how it communicates with the watch? Does it use nfc, Bluetooth, or the interface on the one side inside the Apple Watch band area? Just wondering.

If it's like the Kardia for iPhone and Android, it's ultrasonic.
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So let's get this right. What normally needs a 10 electrode chest and limb placement for a diagnostic 12 Lead ECG this amazing device can do it by using your .... thumb. Two outcomes. It's regular. Or it's not. If it's not. It's Atrial Fibrillation. If it is. It's Normal Sinus Rhythm. Really? Really? Good luck with that. A classic example of a little 'knowledge' being a bad thing.

MB Hockey is right. It's a single-lead ECG, so it's limited in what it can diagnose (it _won't_ detect or predict an impending MI, which you need a full 12-lead ECG for), but the Alivecor is effective in diagnosing AF and monitoring heart rate and rhythm. In particular, it lets you distinguish between a few irregular beats and a persistent AF, and that "little knowledge" can be a pretty good thing. The main risk from AF is stroke, not a heart attack, and there are people who have chronic AF and live with it because they're not good candidates for cardiac ablation or other definitive treatments. What they do have to do is stay on an anticoagulant so blood clots won't form in the heart and travel to the lungs or brain.

I've had three AF episodes in the last two years, and the last one happened during a hockey game (I'm a ref). I did a check between periods, found I was in AF, knew I was otherwise OK, finished the game, and started my medication and called my cardiologist as soon as I got back to the dressing room. The other benefit of using the Alivecor is to check rhythm and verify that it's normal if something feels unusual (like the heart rate being low). It saved a couple of calls/visits to the doctor.

 

[tennisproha]

There is already a law to prohibit genetic discrimination for heath insurance and employment. It was passed in 2008:

http://ginahelp.org/

People can NOT be denied health coverage due to their DNA:

GINA makes it against the law for health insurers to request, require, or use genetic information to make decisions about:

• Your eligibility for health insurance
• Your health insurance premium, contribution amounts, or coverage terms

See, some times our government works for us! amazing. Now we must make sure this law does not get watered down. They already tried to with the Health care repeal bill that failed. It had a provision that allowed Heath insurance companies to use DNA data to set premiums! I'm sure there will be future bills to try an allow this. We must be smart and push back

Thank you for this info. This is good. I was not aware that there already was a law in place. But as you say we still need to be cognizant of what's happening since laws can change. This is a brave new frontier and I feel people aren't as aware of the implications of the technology around them as they should be.

That statement is not entirely true if we're talking about the United States. The Genetic Information Nondiscrimination Act (GINA) makes it illegal (for now) in the US for insurance companies to deny coverage or raise rates for clients or potential clients based on genetic information. However, GINA does not cover disability insurance, long-term-care insurance, or life insurance. It's therefore possible that individuals in the US have already been denied health-related insurance based on genetic information. "Health coverage" usually implies traditional health insurance, though. It might seem like I'm being overly picky about the semantics of the statement, but this an important issue and an issue where the details are important.

Ah you're right. I had read about it somewhere but I couldn't remember the exact details. I still felt it was important enough to be mentioned for people to know about.

Now that you mention it, it was regarding life insurance. People were denied life insurance and when they dug further it was reveal that it was because of genetic data the insurer had obtained about them.

 

[burgman]

So let's get this right. What normally needs a 10 electrode chest and limb placement for a diagnostic 12 Lead ECG this amazing device can do it by using your .... thumb. Two outcomes. It's regular. Or it's not. If it's not. It's Atrial Fibrillation. If it is. It's Normal Sinus Rhythm. Really? Really? Good luck with that. A classic example of a little 'knowledge' being a bad thing.

You’re right but in this case it’s you having little knowledge about how these sensors work. Do some basic research, I know it’s hard. Funny a person on the internet claims to know more than the companies involved, many doctors who use this in their practices, and the FDA. Too funny, or sad I’m not sure which.

 

[Morgenland]

Promising tool, but subscription to AliveCor's premium service ($99 a year) sucks. By reading this line, my buying interest was eliminated. Which unworldly "modern" marketing consultants have infected that company? Subscription software is an idea of yesterday.
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Android wear version coming soon*

*in 2028

who cares!

 

[MBHockey]

But they are hypochondriacs. They go bananas when they sneeze in the middle of summer. But for people with actual heart issues this band is cool and important tech.
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Your above post seems to suggest you don't understand the difference between a heart attack and heart failure. Afib is more connected with heart failure. Lots of people live with heart failure who have never had a heart attack and this band could give them a heads up.

In my attempt to make my post more readable by non-clinicians (like yourself) I may have confused you.

I'm a physician. What I am saying is that while this device is certainly pretty cool, to call it life-saving is quite a leap. It is essentially a rhythm strip. The information you can get from a rhythm strip is...largely limited to abnormal heart rhythms. Further, the potentially lethal heart rhythms (runs of vtach, vfib, complete heart block) do not seem to be detected/reported by this device.

It seems to only report on a-fib. While that's great, it's hardly a malignant rhythm. Yes, you should know if you are in afib, and go see your doctor, but there are certainly more dangerous things detectable with a rhythm strip that this device seemingly does not.

The device also cannot give a meaningful indication of cardiac ischemia, something that invariably precedes sudden cardiac death from an MI, since it only has one lead.

Lastly, when you say:

Afib is more connected with heart failure. Lots of people live with heart failure who have never had a heart attack and this band could give them a heads up.

I'd really like to know what you mean by this. Do you think that heart failure and afib are the same thing? Do you understand what heart failure is? Do you think that afib causes heart failure? Please, explain this. I'll make some popcorn.

Next time you decide to act internet-tough, pick a topic you know something about.

 

[dumoore]

It's strapped to your wrist right across your Ulnar and Radial arteries (Wrist arteries) but you have to press your thumb on it? Can't they measure the activity straight from your wrist? I feel like that's a huge missed opportunity that way you can catch an event before you even know it's happening, the watch could literally alert you that something weird is going on.

 

[enc0re]

Isn’t it a two lead device? I think there’s a sensor on the inside and outside of the band.

 

[ErikGrim]

Ok so this really isn’t about the Apple Watch. In theory they could just create a wearable band that synced with your phone.

That’s true. They do in fact sell that product as well.

where it can detect abnormal heart rhythm and atrial fibrillation (AF), much like AliveCor's existing KardiaMobile device.

 

[MBHockey]

Isn’t it a two lead device? I think there’s a sensor on the inside and outside of the band.

It may have two 'points of contact' but two anatomic leads (ie, clinically useful) for an ECG have to be measuring different vectors of electrical conduction in the heart. They would have to be physically further away from each other than just the two points of contacts on the patient's wrist. See the pic below.

 

[enc0re]

It may have two 'points of contact' but two anatomic leads (ie, clinically useful) for an ECG have to be measuring different vectors of electrical conduction in the heart. They would have to be physically further away from each other than just the two points of contacts on the patient's wrist. See the pic below.

I’m not a physician. I thought the way it worked was that one lead connects to the left wrist on the inside of the band and the other to your right thumb that you have to place on the outside of the band. In other words, it’s measuring across your arms; not with two contacts on the same wrist.

 

[MBHockey]

I’m not a physician. I thought the way it worked was that one lead connects to the left wrist on the inside of the band and the other to your right thumb that you have to place on the outside of the band. In other words, it’s measuring across your arms; not with two contacts on the same wrist.

It's not clear to me from the videos how it works, ie if it has a lead on the left wrist or a lead on both upper extremities. I imagine that if they did have a second lead on the right arm, they'd give you two leads of information instead of one.

There's not much this offers over the standard built-in HRM in the apple watch, which can also tell you if your rhythm is 'regular' or 'irregular'. That is essentially all this device is doing (in terms of clinically useful information).

Calling it a "medical grade EKG" is deliberately misleading marketing, unfortunately. If it was able to detect and report something like "wide complex tachycardia" vs "narrow complex tachycardia", that would be helpful clinically and something the AW cannot do with the built-in HRM, for example.

 

[BruceEBonus]

You’re right but in this case it’s you having little knowledge about how these sensors work. Do some basic research, I know it’s hard. Funny a person on the internet claims to know more than the companies involved, many doctors who use this in their practices, and the FDA. Too funny, or sad I’m not sure which.

Mate. If you only knew. Keep ignorant.

 

[Allyance]

They make a stand alone unit for $99 and the wrist unit for $199. Not sure if communicates directly with watch, but iPhone App is required. These devices are not meant to replace professional devices, but to give an early warning. I have the iHeart blood pressure cuff/app and it fairly close when I use it at my dr. office too.

 

[jaw1964]

Medical smartphone accessory company AliveCor this week received FDA-approval for its EKG Kardia Band, the first medical-grade accessory for Apple Watch. The band has been available in Europe for some months, but the product's clearance by the FDA means it can now be sold in the United States.

The Kardia Band for Apple Watch has an integrated metallic sensor in the strap that enables it to communicate with the company's app to take EKG readings, where it can detect abnormal heart rhythm and atrial fibrillation (AF), much like AliveCor's existing KardiaMobile device.

However, the latter device attaches to the back of an iPhone and requires users to hold their phone with both hands for 30 seconds to register a reading, whereas the Kardia Band lets wearers take readings discreetly wherever they are and in real time.

Users need only navigate to the Apple Watch-compatible Kardia app, start a reading, place their thumb on the sensor, and wait for the 30-second analysis to finish. During this time, they can also speak into the Apple Watch's microphone to note the presence of palpitations or shortness of breath, or any dietary habits that could be linked to heart-rate fluctuations.

Recordings are stored and viewed in the Kardia iPhone app, and can also be sent to the user's doctor. The app also connects to Apple's stock Health app, so users can integrate their EKG readings into other fitness data for a more comprehensive picture of their overall health.

According to TechCrunch, AliveCor is also introducing a new feature called SmartRhythm that utilizes a neural network for better insights into heart rate data. The company says SmartRhythm can potentially detect an abnormal heart beat using the Kardiaband or KardiaMobile EKG reader.

The AliveCor Kardia Band costs $199 and can be ordered directly from the company's website or from Amazon. Readers should also note that a subscription to AliveCor's premium service ($99 a year) is required to access all of the available features once the 30-day trial period ends.

(Thanks, Anna!)

Article Link: AliveCor 'Kardia Band' Medical Grade EKG Analyzer for Apple Watch Receives FDA Approval

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The AliveCor Kardia Band costs $199 and can be ordered directly from the company's website or from Amazon. Readers should also note that a subscription to AliveCor's premium service ($99 a year) is required to access all of the available features once the 30-day trial period ends.

Potential buyers should also be aware that "All of the available features" to be used include the functioning of the band itself. If you choose not to buy into the $99/year service, you are stuck with a $199 watchband that does nothing. It won't even track your heart rate as advertised without the subscription.

 

[Allyance]

Just ordered the KardiaBand, will report on how well it works and what my Cardiologist says after appointment in Feb.