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FDA clears AliveCor’s KardiaBand as the first medical device accessory for the Apple Watch

Posted on November 30, 2017

Wearable technology such as the Apple Watch have shown promise with their fitness capabilities, and the future has always appeared bright in relation to their value to healthcare, but technology hasn't caught up to the potential. Until now.

AliveCor just became the first company to get an Apple Watch accessory cleared by the US Food and Drug Administration (FDA) as a medical device.

What is the AliveCor KardiaBand?

Simply put, the AliveCor KardiaBand is a watch band for the Apple Watch that allows the user to take an EKG reading by placing their finger on a sensor pad that is located on the watch band. Within 30 seconds, the user has their EKG, which can be used to detect abnormal heart rhythm and atrial fibrillation (AFib).

In an interview with TechCrunch, AliveCor CEO, Vic Gundotra, had this to say:

“Apple might be able to say ‘oh your heart rate is high’ …but what does that mean? Does that mean you should go to the hospital? And if you go to the hospital what are they going to do?. Any doctor will say ‘ok come in, lets get an EKG reading’,” Gundotra told TechCrunch.

EKGs are usually only available in offices and hospitals — and only after a life-threatening event. Having one on your wrist that you can use to check your heart and then send a readout straight to your doctor is vital to prevention of a heart attack or stroke.

And, as Gundotra also points out, “It’s not possible to diagnose atrial fibrillation without FDA clearance. That is a big, big play.”

Why the KardiaBand is Important?

From a personal perspective, I've wanted a device like this since the Apple Watch was introduced. While I do not have AFib, I do suffer from frequent abnormal heart rhythms called Tachycardia's. They are typically benign, but there is no telling when, and if, one of the events will be more severe. Having a device like this literally at my finger tips would bring a sense of peace as I would automatically know if an abnormal rhythm is detected.

In the past, the only way to catch an abnormal rhythm was to have it happen when getting an EKG at the doctor or by wearing a halter monitor for several days. That is not practical, or safe.

The other benefit I see is not having to go to my cardiologist twice per year just to get an EKG reading. No more wires and gels, just a simple finger placement on a watch band that I already wear everyday. Additionally, the cost savings to insurance companies has to be substantial. 

I've never asked for a breakdown of what my cardiologist charges the insurance company for the EKG diagnostic reading, but I have to believe it is more expensive than the $199 that AliveCor is charging for KardiaBand. For the full functionality, including potentially detecting abnormal heart beats, you would need to pay $99/year for a software feature called SmartRhythm. 

Still, there is no doubt this is cheaper that the alternative.

What Cardiologists Are Saying?


The Apple Watch has been fantastic for fitness tracking. 

For health / patient monitoring up to this point? Not so much.

The AliveCor KardiaBand looks like a great step in helping unlock Apple Watch's potential in healthcare. 

I do expect to give it a shot as you can pay with pre-tax dollars using your FSA, HSA or HRA. This is important as many of us still have funds left to use before 2018.