FDA Clears Medical Device Accessory for Smart Watch

The first medical device accessory for a Smart Watch has been approved for use by the U.S. Food and Drug Administration (FDA).

Smart Watch users can now discreetly capture their electrocardiogram (EKG) by using an attachable sensor developed by medical technology company AliveCor.

The device attaches to the strap of the Smart Watch and users are able to record and see the results of an EKG in 30 seconds. By placing their thumb on the integrated sensor, users can quickly detect normal sinus heart rhythms and atrial fibrillation (AFib).

Atrial Fibrillation is the most common type of heart arrhythmia and is leading cause of stroke. It occurs when a person has irregular beats in the upper of the chambers of the heart and when blood flow doesn’t flow as well as it should from the atria to the ventricles of the heart.

A new feature within the Kardia app for the Smart Watch is also being introduced by AliveCor. The SmartRhythm feature uses Artificial Intelligence alongside inputs form the Smart Watch’s heart rate and activity sensors to continuously monitor the correlation between heart activity and physical activity. When the two metrics are out of sync, users are notified to capture an EKG.

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

Dr. Ronald P. Karlsberg, board certified cardiologist and clinical professor of Medicine, Cedars Sinai Heart Institute and David Geffen School of Medicine UCLA, said: “Today, EKGs are available only in offices and hospitals, using complex equipment, and usually only after a life-threatening event, for example a stroke. With an EKG device on the wrist, AFib can be detected wherever the patient is, 24 hours a day. In randomised research trials, KardiaMobile, the first AliveCor EKG device, proved to be superior to routine care provided by physicians. Today, KardiaBand is a giant leap in personalized health care.”

Source: Med Tech News

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