The Food and Drug Administration has approved the use of the Apple Watch in clinical trials dealing with atrial fibrillation, a type of abnormal heartbeat.
In an alert Monday, the agency touted the move as the first digital health device to qualify for use in clinical trials, adding that it provides people conducting the trials a noninvasive way of measuring the atrial fibrillation risk in trial participants.
If the user allows it to, Apple says the smartwatch can measure a heart rate via wrist detection, as well as other health factors. This allows the device to compile data on the wearer’s history and potential risk of atrial fibrillation.
The atrial fibrillation feature is meant for users 22 years and older, Apple says on its website.
In one clinical study where an electrocardiogram patch was also used for reference, the Apple Watch’s abnormal heartbeat detection feature “demonstrated a sensitivity of 88.6% and a detection specificity of 99.3%,” Apple added.
The Apple Watch can also measure how effective a cardiac ablation device, which treats abnormal heartbeats, is in dealing with the condition.
• Brad Matthews can be reached at bmatthews@washingtontimes.com.
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