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.

Kardia Band apple watch
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 Roundup: Apple Watch 10
Buyer's Guide: Apple Watch (Neutral)

Popular Stories

iCloud General Feature Redux

iPhone Users Who Pay for iCloud Storage Receive a New Perk

Thursday March 20, 2025 12:01 am PDT by
If you pay for iCloud storage on your iPhone, Apple has a new perk for you, at no additional cost. The new perk is the ability to create invitations in the Apple Invites app for the iPhone, which launched in the App Store last month. In the Apple Invites app, iCloud+ subscribers can create invitations for any occasion, such as birthday parties, graduations, baby showers, and more. Anyone ...
Generic iOS 19 Feature Mock

iOS 19 Coming in June With These New Features

Thursday March 20, 2025 2:04 pm PDT by
While the first iOS 19 beta is still more than two months away, there are already plenty of rumors about the upcoming software update. Below, we recap the key iOS 19 rumors so far. visionOS-Like Design In January, the YouTube channel Front Page Tech revealed a redesigned Camera app that is allegedly planned for iOS 19. According to Front Page Tech host Jon Prosser, the Camera app...
apple wallet drivers license feature iPhone 15 pro teal 1

Apple Says iPhone Driver's Licenses Coming to These 8 U.S. States, But Rollout Remains Slow

Wednesday March 19, 2025 6:55 am PDT by
In select U.S. states, residents can add their driver's license or state ID to the Wallet app on the iPhone and Apple Watch, providing a convenient and contactless way to display proof of identity or age at select airports and businesses, and in select apps. Unfortunately, this feature continues to roll out very slowly. It has been three and a half years since Apple first announced the...
Windows Vista

Apple Might Be Having Its Windows Vista Moment, Says Analyst

Thursday March 20, 2025 6:52 am PDT by
Is Apple experiencing a "Vista-like drift into systemically poor execution?" That was a question posed by well-known technology analyst Benedict Evans, in a recent blog post covering Apple's innovation and execution, or seemingly lack thereof as of late. He is referring to Microsoft's Windows Vista operating system, which was widely criticized when it launched in 2007 due to software bugs,...
iPhone 17 Pro Render Front Page Tech

Latest iPhone 17 Pro Dummies Highlight Apple's New Part-Glass Design

Thursday March 20, 2025 5:27 am PDT by
Seasoned leaker Sonny Dickson has shared more dummy models of Apple's upcoming iPhone 17 series, with the latest lot revealing a noticeable shift in Apple's iPhone Pro model design that goes beyond the much-talked-about new rear camera bar. Dickson points out that the iPhone 17 Pro dummy models feature an outlined area on the back, beginning just below the camera module and extending to the...
iOS 18

Top 5 New Features Coming in iOS 18.4

Friday March 21, 2025 3:26 pm PDT by
We're not getting new Siri Apple Intelligence features in iOS 18.4 as expected, but the upcoming update does have quite a few new additions that will be worth upgrading for. We've rounded up the five best features to look forward to, and if you're not running the beta, you can expect to get access to these in early April. Priority Notifications If you have an iPhone or iPad that supports...
airtag orange

Apple's Next Product is Likely an AirTag 2 With These New Features

Thursday March 20, 2025 2:30 pm PDT by
Following the introduction of the iPhone 16e, new iPads and Macs, and some new accessories over the past month, what will Apple's next product announcement be? Based on rumors, a second-generation AirTag item tracker is likely next up. Last year, Bloomberg's Mark Gurman reported that a new AirTag would be released around the middle of 2025. More recently, a leaker known as Kosutami claimed...
airpods pro 2 gradient

AirPods Pro 3 Launch Now Just Months Away: Here's What We Know

Tuesday March 18, 2025 9:13 am PDT by
Despite being released over two years ago, Apple's AirPods Pro 2 continue to dominate the wireless earbud market. However, with the AirPods Pro 3 expected to launch in 2025, anyone thinking of buying Apple's premium earbuds may be wondering if the next generation is worth holding out for. Apart from their audio and noise-canceling performance, which are generally regarded as excellent for...
iPhone 17 Air Fanned Feature

First iPhone 17 Air Case Has Camera Bar, Camera Control Button Cutouts

Wednesday March 19, 2025 5:29 am PDT by
Serial leaker Sonny Dickson today shared an image of what he claims is a first look at a third-party case for Apple's iPhone 17 Air. "If you didn’t know an Air was coming, you'd swear it was a Google Pixel case," he said. Case manufacturers often obtain design specifications of upcoming iPhone models before their release by collaborating with Apple through official partnerships or...

Top Rated Comments

HiRez Avatar
95 months 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.
Score: 13 Votes (Like | Disagree)
tennisproha Avatar
95 months 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.
Score: 9 Votes (Like | Disagree)
zapmymac Avatar
95 months 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.
Score: 7 Votes (Like | Disagree)
gwaizai Avatar
95 months ago
I feel sorry for hypochondriacs. They're going to drive themselves bananas with this thing.
Score: 4 Votes (Like | Disagree)
mdmitchell Avatar
95 months 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.
[doublepost=1512064375][/doublepost]
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.
Score: 4 Votes (Like | Disagree)
JeffyTheQuik Avatar
95 months 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.
Score: 3 Votes (Like | Disagree)