The FDA just cleared an EKG reader accessory for the Apple Watch, making it the first medical device accessory of its kind on any smartwatch in the United States.
On Thursday, the Food and Drug Administration finally cleared AliveCor’s KardiaBand, an EKG reader accessory for Apple Watch designed to track and detect abnormal heart rhythm and atrial fibrillation (AFib).
To date, AliveCor uses its KardiaMobile device, which is usually attached at the back of a smartphone and paired with a mobile app, to detect abnormal heart rate and AFib. With the Apple Watch, the EKG reader will be an accessory placed on the watch’s band.
Unlike the KardiaMobile device which has to be held with both hands to take EKG readings, the KardiaBand will enable continuous and discreet EKG reading just by touching the sensor attached to the band.
AliveCor’s KardiaBand is powered by an artificial intelligence software called SmartRhythm which learns a person’s heart rhythm and AFib over time. SmartRhythm allows the EKG reader to ping users to take extra readings when it detects sudden changes to heart rate based on previous readings.
As mentioned, the KardiaBand comes is an accessory, so you have to purchase it separately. The band costs $200 USD and requires a $99 USD annual subscription for a person to access the app’s sharing features, cloud storage, and incorporation of weight and blood pressure measurements.
Also, for an additional fee of $9 USD, AliveCor can have the readings analyzed by a Cardiac Technician and return the results in an hour or less. But, if you want a more thorough analysis, you may pay $19 USD for the readings to be assessed by a U.S. Board Certified Cardiologist.FDA cleared the EKG reader accessory of @AliveCor for the @Apple watchClick To Tweet
AliveCor’s EKG Reader to Aid Apple’s Study?
Yesterday, Apple launched the Apple Heart Study app, the first-ever study conducted in partnership with Stanford University’s College of Medicine, which will make use of the Apple Watch’s heart rate sensor. According to the company, the study aims to notify users who are potentially suffering from atrial fibrillation based on the heart rhythm data gathered by the app.
AFib is a common type of arrhythmia or condition where the heart beats irregularly, either too slow or too fast. AFib usually occurs in brief episodes but may also be a permanent condition to some.
In the United States alone, AFib affects around 2 to 6 million people and accounts for 130,000 deaths each year in the country. In the data released by Centers for Disease Control and Prevention this year, it is said that AFib costs the U.S. government about $6 billion USD each year.
While the Apple Heart Study app has no capability to diagnose conditions YET, it is said to be perfectly positioned to detect any irregular heartbeat. Some believe that the clearance given by FDA to AliveCor’s EKG reader may aid Apple and Stanford researchers in their study. In a statement to TechCrunch, AliveCor CEO Vic Gundotra said:
“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, let’s get an EKG reading’.”
To date, EKG readers are only available in offices and medical establishments like hospitals and clinics. Having one in a person’s wrist can make a world of difference, especially for those people suffering from AFib.
“It’s not possible to diagnose atrial fibrillation without FDA clearance. That is a big, big play,” Gundotra went on to say.
Apple has not announced any collaboration with AliveCor for their heart study.