KardiaBand Received U.S. FDA Approval

The U.S. Food and Drug Administration (FDA) approved the KardiaBand, as announced in December 2017.

KardiaBand is the first device to have received FDA-clearance to be used as a personal electrocardiogram (EKG) accessory designed to accompany an Apple Watch.

The KardiaBand enables easy interpretation of EKG readings in order to distinguish between normal sinus heart rhythms and atrial fibrillation (A-fib), commonly kinds of serious heart arrhythmia, which cause strokes or other heart-related problems. The band is designed to record an EKG a short span of 30 seconds. By simply touching an integrated sensor, a user can view results displayed on the Apple Watch.

The launch of SmartRhythm, a new feature in the Kardia app was also announced. The feature relies on artificial intelligence to monitor the heart rate of a user and also helps determine the correlation between heart activity and physical activity. The updated app thus has the ability to detect when the heart rate and activity of a user are out of sync, further promptly alerting the user about the same.

Vic Gundotra, CEO of AliveCor said “KardiaBand paired with SmartRhythm technology will be life-changing for people who are serious about heart health.”

He further said “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 A-fib, a leading cause of stroke, and other serious conditions.”

KardiaBand is available in combination with AliveCor’s Premium subscription service of US$ 99 per year. This combined system allows for SmartRhythm notifications on Apple Watch, unlimited recordings of EKG, and automatic detection of A-fib or normal sinus rhythms.

These readings can be emailed to anyone a user wishes to share the information with. This would help in easy transfer of real-time readings to doctors for diagnosis and interpretation. It also provides users with an unlimited cloud access to their EKG readings, along with weight and medication tracking.

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