The Food and Drug Administration has just authorized AliveCor's Kardiaband EKG reader as the first medical device accessory for Apple Watch.
Europe has been able to use a version of Kardiaband for Apple Watch for some time but, thanks to the new FDA approval, the device can now be used in the United States. United, marking the first time that an Apple Watch accessory will be usable as a medical device in the States.
Up to now, AliveCor was using the KardiaMobile device, which was stuck to the back of your smartphone and associated with an app to detect abnormal heart rhythm and atrial fibrillation (FibA). The new Apple Watch accessory, Kardiaband, clicks into a Watchband slot to do the same thing.
However, instead of having to hold your smartphone with both hands for 30 seconds to get a reading, you can get an EKG reading continuously and discreetly by simply touching the built-in sensor of the group.
With the new Kardiaband for the Apple Watch ad, AliveCor introduces a software feature called SmartRhythm, which uses a deep neural network to give you insight into your heart rate and can potentially detect an abnormal heartbeat by using the Kardiaband or KardiaMobile ECG reader.
Note that there have been a few studies conducted using only the built-in heart rate monitor from the Apple Watch to detect an abnormal heart rhythm. This spring, UCSF and Cardiogram conducted such a study, concluding that the Apple Watch could detect an abnormal heart rhythm with an accuracy of 97% when it was associated with an AI-based algorithm called DeepHeart.
Later, the same eHealth study concluded that the watch could also detect sleep apnea and hypertension with similar accuracy using its built-in sensor.
But, as the CEO of AliveCor, Vic Gundotra points out, it is one thing to be able to detect and another thing to get the approval of the FDA to use your sensor as a medical device.
"Apple might be able to say" oh, your heart rate is high "… but what does it 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, let's read an ECG," Gundotra told TechCrunch. .
Electrocardiograms are usually only available in offices and hospitals – and only after a potentially fatal event. Having one on your wrist that you can use to check your heart and then send a reading directly to your doctor is essential for the prevention of a heart attack or stroke.
And, as Gundotra also points out, "it is not possible to diagnose atrial fibrillation without FDA clearance.This is a big, large piece."
It should be noted that Apple could easily replicate what AliveCor does. He has all the right equipment within the Apple Watch and the manpower to do it. However, it does not seem likely that Apple would want to go through the hassle of FDA approval for the watch, which is a versatile device used for many other applications besides getting your frequency heart.
The FDA also told TechCrunch in the past that it would be the software, not the platform on which it operates, that would be regulated anyway.
That does not mean that anyone else could not find an EKG reader approved by the FDA but until now, AliveCor seems to have the same market for KardiaMobile and now Kardiaband.
This is an important marker for the company. AFib is the most common cardiac arrhythmia and one of the leading causes of stroke. In fact, one in four adults over 40 may be at risk.
"This is a medical device.This is not a toy that says your heart could be irregular.This is an FDA approved device.It is one of the things the more difficult than I've ever done in my life, "Gundotra said.
Interested persons can get their own Kardiaband from $ 199 on the AlivCor website. The group requires a premium subscription to AliveCor for $ 99 a year.