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

[MacRumors]

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

 

[HiRez]

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.

 

[zapmymac]

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.

 

[tennisproha]

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.

 

[djcerla]

Android wear version coming soon*

*in 2028

 

[MacWorld78]

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.

 

[travelsheep]

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.

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.

 

[gwaizai]

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

 

[soanis]

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

 

[Phonephreak]

Android wear version coming soon*

*in 2028

There’s Always one to ruin the discussion
[doublepost=1512040793][/doublepost]This is a big deal. Not easy to get fda approval. This is the future
[doublepost=1512040839][/doublepost]

I would kill for some broccoli and steamed rice right now

With lots of hot sauce.

 

[jamesnajera]

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.

 

[Rogifan]

So what does the Watch have to do with this band? Does the band only work when it’s connected to the Watch? How does that work because it doesn’t appear that there’s any special connector on the band. Could the band communicate directly with an iPhone? Or does it need the heart rate sensor from the Watch?

 

[ErikGrim]

So what does the Watch have to do with this band? Does the band only work when it’s connected to the Watch? How does that work because it doesn’t appear that there’s any special connector on the band. Could the band communicate directly with an iPhone? Or does it need the heart rate sensor from the Watch?

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.

 

[Kabeyun]

Just know that this is basically a rhythm sensor. It looks like it uses the electrical feed from one limb to determine the presence of an irregular rhythm. Actual EKG’s have four limb leads and six precordial leads by the heart, and can give a lot of information, including cardiac ishemia, heart attack (including its age), atypical arrhythmias, and even the effect of some medications. This isn’t that. It looks like it primarily detects afib, which causes your pulse to beat irregularly. I think it does so with an electrical sensor, although I’ll bet the AW’s built in pulse sensor could do it.

 

[BruceEBonus]

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.

 

[ErikGrim]

I think it does so with an electrical sensor, although I’ll bet the AW’s built in pulse sensor could do it.

That is exactly what Apple is running a trial on in the US right now.

 

[Phonephreak]

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 a little knowledge leads you to go to a md and get checked out.

 

[JeffyTheQuik]

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.

 

[MBHockey]

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.

I wouldn't say this can literally save your life. Sure, it can detect afib, and while that is cool from a watch it is unlikely to be a sign of impending death. It's more of a "you should go to your doctor" reminder.

This is a single lead of a 12 lead EKG, meaning it does not have the ability to detect heart attacks or early signs that a heart attack may be coming. Its only purpose seems to be to detect afib. You could potentially detect heart blocks as well from a single lead, and they can be a lot more dangerous than afib, but it doesn't seem this device does that specifically.

It isn't doing more than putting your finger on your pulse and feeling that it is irregular.

 

[Chupa Chupa]

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

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.
[doublepost=1512048854][/doublepost]

I wouldn't say this can literally save your life. Sure, it can detect afib, and while that is cool from a watch it is unlikely to be a sign of impending death. It's more of a "you should go to your doctor" reminder.

This is a single lead of a 12 lead EKG, meaning it does not have the ability to detect heart attacks or early signs that a heart attack may be coming. Its only purpose seems to be to detect afib.

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.

 

[Mike Oxard]

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.

Probably the same way that the KardiaMobile does, through emitting a high frequency signal, detected by the phones microphone. It's great for annoying teenagers with! If so it means it'll probably be usable with the phone version of the app as well.

The article is slightly misleading, the KardiaMobile doesn't need to be attached to teh phone, it's just a convenient way to carry it. You can have it on the table in front of you, the phone can be elsewhere so long as it's quite near (a couple of feet) and your not blocking the mic.

 

[Rogifan]

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.

 

[tkukoc]

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.

 

[peteo]

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

 

[Mike Oxard]

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

I just tried the watch app with my KardiaMobile . It asks if you have the band, but it still works with the sensor pad, so it must still be using audio to transmit the reading, just to the watch's mic instead of the phone's. It recorded the reading on my watch then synced it to my phone. It could sync with anything with a good enough mic.

Edit: I noticed that although the KardiMobile is in the same orientation I usually use it in, the EKG trace is inverted.