The Food and Drug Administration has just cleared AliveCor’s[1] Kardiaband EKG reader as the first medical device accessory for the Apple Watch.
Europe has been able to use a version of the Kardiaband for Apple Watch for some time now but, thanks to the new FDA approval, the device can now be used in the U.S., marking the first time an Apple Watch accessory will be able to be used as a medical device in the States.
Up until now, AliveCor has used the KardiaMobile device, which was stuck to the back of your smartphone and paired with an app to detect abnormal heart rhythm and atrial fibrillation (AFib). The new Apple Watch accessory, Kardiaband, clicks into a slot on the Watch band to do the same thing.
However, rather than needing to hold your smartphone with both hands for 30 seconds to get a reading, you can get an EKG reading continuously and discreetly just by touching the band’s integrated sensor.
Along with the new Kardiaband for Apple Watch announcement, AliveCor is introducing 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 heart beat using the Kardiaband or KardiaMobile EKG reader.
Note, there have been a couple studies conducted using just the Apple Watch’s built-in heart rate monitor to detect an abnormal heart rhythm. This spring, UCSF and Cardiogram conducted one such study, concluding the Apple Watch could detect an abnormal heart rhythm with a 97 percent accuracy[2] when paired with an AI-based algorithm called DeepHeart.
Later, the same eHealth study concluded[3] the Watch could also detect sleep apnea and hypertension with similar accuracy...