“The Food and Drug Administration has just cleared AliveCor’s Kardiaband EKG reader [US$199 with $99 annual subscription] as the first medical device accessory for the Apple Watch,” Sarah Buhr reports for TechCrunch. “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. 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,” Buhr reports. “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.”
“AFib is the most common heart arrhythmia, and a leading cause of stroke. In fact, one in four adults over the age of 40 could be at risk,” Buhr reports. “‘This is a medical device. This is not a toy that says your heart might be irregular. This is an FDA-cleared device. It’s one of the hardest things I’ve ever done in my life,’ [AliveCor CEO Vic] Gundotra said.”
Read more in the full article here.
MacDailyNews Take: This is a big deal for both companies. For Apple, it reinforces the fact that Apple Watch is a sophisticated wearable computer.