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

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!)

Related Roundups: Apple Watch, watchOS 4
Buyer's Guide: Apple Watch (Neutral)


Top Rated Comments

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12 weeks ago
I don't want to overhype the technology too much, but it's really cool that we're seeing these small, relatively cheap consumer devices that, in some circumstances, can literally save your life. You hear about people having strokes, heart attacks, cardiac arrhythmias, and so forth, and while people survive them, many people do die because they didn't know what was happening or didn't get to a doctor or hospital in time.
Rating: 13 Votes
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12 weeks ago
The most important thing we need to be aware of in this space is who owns the data that is collected by these devices.

I've heard of people who were denied health coverage because of the DNA sequencing they ordered and failed to realize that they didn't own that data.

We need to push for digital privacy laws like yesterday.
Rating: 9 Votes
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12 weeks ago
I am healthy, but I sure wouldn't mind having this feature, and info given to my doc at my yearly physical. Gladly pay for the hardware, but not the subscription.
Rating: 7 Votes
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12 weeks ago
I feel sorry for hypochondriacs. They're going to drive themselves bananas with this thing.
Rating: 4 Votes
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12 weeks ago

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.
Rating: 3 Votes
Avatar
12 weeks ago

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.

Or...

This is a first step into getting better information.

I'm a T1 diabetic, and when I was a kid, we used urine tests to test our blood sugar (huh?), as it was an indicator that your kidneys were filtering out the sugar, and putting it in your urine. Blood sugars were done at the doctor's office every 6 months, or at home with a strip you put blood on, waited a minute, wiped the blood off, and then matched it to a color code on the side of the canister, and it had a +/- 30% rating, and a huge person to person variability.

Then came the electronic testers, and the test was to put a drop of blood on a strip held in the tester (that cost $500 in 1979 dollars, about $1700 today), and it was an optical read of the color of the strip, and it was moderately accurate (+/- 20%, and for some diabetics, having an actual blood sugar of 60 vs. 72 (edge of tolerance) is a huge thing, but I digress).

Today, there are electronic testers at Walmart that are accurate to within 10%, and they are about $20, and the test strips are 80 cents each, and they are in the "a little knowledge" category that you detail, as there are better ways, which is the continuous glucose monitor, which tests blood glucose to within 5%, do a reading every 5 minutes, and let you know when things are going bad.

Like I said, this is a step in the road to better health.
Rating: 3 Votes
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12 weeks ago
I currently have Apple Watch 3, I will upgrade once Apple integrate two things:

- ECG
- diabetes check without pricking

It would be damn cool if Apple Watch can detect from the ECG that you are about to have strokes or heart attacks - it will automatically call emergency and send your accurate GPS location & medical ID for you.
Rating: 2 Votes
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12 weeks ago

Looks like it has its own sensor and not reliant on the watch in any way. Having it in a band form factor is just convenience.

Ok so this really isn’t about the Apple Watch. In theory they could just create a wearable band that synced with your phone.
Rating: 1 Votes
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12 weeks ago

The most important thing we need to be aware of in this space is who owns the data that is collected by these devices.

I've heard of people who were denied health coverage because of the DNA sequencing they ordered and failed to realize that they didn't own that data.

We need to push for digital privacy laws like yesterday.


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
Rating: 1 Votes
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12 weeks ago

plus it can automatically order Steak and fries with extra cheese to be sent to the hospital, so you don't have to wake up to broccoli and steamed rice.


I would kill for some broccoli and steamed rice right now
Rating: 1 Votes
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