FDA approval of Apple Watch medical accessory is world’s first

Chris Burns - Nov 30, 2017
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FDA approval of Apple Watch medical accessory is world’s first

An EKG reader by the name of KardiaBand is officially the first Apple Watch medical accessory to be approved by the FDA. This device works with the Apple Watch to detect abnormal heart rate. KardiaBand allows users to take a single 30 second EKG on their own wrist with a tap.

The company that makes this KardiaBand is AliveCor. They call themselves “the leader in FDA-cleared personal electrocardiogram (EKG) technology. In other words – they’ve done this sort of thing before.

Today they were excited to make known their historic first – being the makers of the first FDA-approved medical device accessory for the Apple Watch. You might recognize the name of the CEO of this company: Vic Gundotra. Gundotra was a very public face for Google for several years a few years ago, back when he launched Google+, Google’s social network.

Now he’s head of the company that makes the product we’re speaking about today. “KardiaBand paired with SmartRhythm technology will be life-changing for people who are serious about heart health,” said Gundotra. “These capabilities will allow people to easily and discreetly check their heart rhythms when they may be abnormal, capturing essential information to help doctors identify the issue and inform a clear path of care to help manage AFib, a leading cause of stroke, and other serious conditions.”

Thee accessory and a subscription service are combined to achieve a full heart monitoring system from AliveCor. With the AliveCor Premium service, users get each of the following services:

• Unlimited EKG recordings
• Automatic detection of Atrial Fibrillation
• Automatic detection of normal sinus rhythm
• Unlimited ability to send EKG readings to email
• Unlimited cloud history and reporting of all EKGs ever taken
• Weight and medication tracking
• A mailed monthly paper report on readings taken each calendar month

The KardiaBand for Apple Watch will be made available starting today. The price of this accessory is approximately $200 USD, and a subscription to AliveCor’s Premium service is required – that’ll cost users $99 a year. Sounds like this product is not for the faint of heart – or maybe not for the faint of wallet.


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