AliveCor's KardiaBand, a device that detect risky heart rhythms, has become the first Apple Watch accessory cleared for medical use by the FDA, the company announced. This device works with the Apple Watch to detect abnormal heart rate.
Technically the heart rate sensor built into the Apple Watch could do the same thing, but Apple doesn't want to put its wearable through the very long FDA approval process (which could even take a year or more). "Are you going to go to the hospital and tell them 'My watch told me my heart rate was over some threshold, what am I supposed to do?' Here, we fire a notification and you can do something".
Apple Watch has collaborated with a medical company to develop an EKG sensor. The Apple Watch's display shows the reading's data using a line graph that's similar to how the Apple Watch shows other heart rate data, and informs the user if their heart rate is normal or abnormal.
AliveCor makes a portable EKG reader - the kind of electric heart monitoring that's standard in hospitals.
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While the optical heart rate sensor found in the Apple Watch's main body can help detect some heart problems, EKM tests require more in-depth data to discover any underlying heart problems.
Now AliveCor, a private medical health company headquartered in Mountain View, California, is releasing a new Apple Watch band that has a built-in EKG sensor. As per the makers, the EKG band is the first-ever medical accessory meant for a wearable that is approved by the Food and Drug Administrations.
And, as Gundotra also points out, "It's not possible to diagnose atrial fibrillation without FDA clearance". Future smartwatch and fitness tracker developers may begin to seek FDA approval instead of relying on accessories but expect additional costs associated with FDA-cleared gadgets. The band is reportedly able to quickly detect a normal sinus heart rhythm and can detect potentially deadly atrial fibrillation, which is the most common heart arrhythmia.
About AliveCor AliveCor, Inc.is pioneering the creation of FDA-cleared machine learning techniques to enable proactive heart care and is recognized around the world for transforming cardiac care.
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Kardiaband for Apple Watch is now available online for USA $199 on AlivCor's website.
"KardiaBand paired with SmartRhythm technology will be life-changing for people who are serious about heart health", said Vic Gundotra, CEO, AliveCor.
The Kardiaband system is available on all Series 3 Apple Watches for $199, though users must also subscribe to AliveCor's Premium service for $99 a year.
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