Photo: AliveCor

With the onslaught of wearable technologies in the past few years, it was only a matter of time before technologies formerly reserved for the doctor’s office made a new home on the human body.

On Thursday, the Federal Drug Administration (FDA) approved the first medical device accessory for Apple Watch, a personal electrocardiogram (EKG) called KardiaBand.

From the healthcare company AliveCor, KardiaBand allows Apple Watch users to discreetly capture their EKG anytime, anywhere in 30 seconds to detect normal sinus heart rhythms or atrial fibrillation (AFib), the most common heart arrhythmia. AFib affects more than 30 million people worldwide, but millions do not know they are at risk. In fact, two out of three stokes can be prevented when AFib is detected in time and treated properly.

Apple Watch patients can record a single-lead EKG by simply touching KardiaBand’s integrated sensor, which communicates with the Apple Watch app, Kardia. The atrial fibrillation detector then uses Kardia’s automated analysis process (algorithm) to instantly detect the presence of AF in an EKG.

“This is a paradigm shift for cardiac care as well as an important advance in healthcare,” said Dr. Ronald Karlsberg, M.D., board certified cardiologist and clinical professor of medicine at Cedars Sinai Heart Institute and UCLA. “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.”

With the news of FDA clearance, the company has also updated the Kardia app, introducing “SmartRhythm.” SmartRhythm uses artificial intelligence in concert with inputs from Apple Watch’s heart rate and activity sensors to continuously evaluate the correlation between heart activity and physical activity. When SmartRhythm detects that heart rate and activity are out of sync, the device notifies users to capture an EKG.

Users can also record voice memos on their Apple Watch to accompany each EKG, to give doctors and caregivers a clearer picture of what was happening at the time of the recording—for example, describing symptoms such as palpitations or external factors like caffeine intake.

Four separate clinical presentations demonstrating KardiaBand’s power were given at the 2017 European Society of Cardiology Congress in September.

The results from hospitals in Hong Kong, Wales and Cleveland all pointed to the device delivering clinical-grade EKGs while on a patient’s wrist. In one study, patients using Kardia had a four-fold increase in AFib diagnosis compared to a control group, while another validated that volunteer senior citizens could perform medical screening of their peers with success. Additionally, AFib detection accuracy using Kardia was remarkably close to that of a physician, with a 94 percent specificity.

KardiaBand is being sold for $199 and requires a subscription to AliveCor’s premium service for $99 a year.