FDA Announces Clearance For Heart Rhythm-Sensing Apps For Apple Watch

The U.S. Food and Drug Administration (FDA) announced clearance for two heart rhythm-sensing mobile applications designed by Apple for the Apple Watch. One creates an electrocardiogram to detect the presence of atrial fibrillation and regular heart rhythm, while the other analyzes pulse rate data to identify irregular heart rhythms and delivers alerts to the user if atrial fibrillation is detected. These capabilities are projected to become available later this year in the U.S.

To measure heart rhythms, a user would press their finger against a button on the watch. After 30 seconds, the watch would deliver a heart rhythm classification, telling the user whether their rhythm is normal or atrial fibrillation. The data are stored in the device’s Health application. From there, users can share the data with their physicians. According to Apple, all health data is encrypted on the device and in the cloud.

“There are several sub-groups of patients that could benefit from this new device. While there are many digital recording devices on the market today, a wearable device for the wrist is obviously easier for most patients—especially a device that could better track patients that have more intermittent symptoms of arrhythmia,” said ACC President, C. Michael Valentine, MD, FACC.

Clinical Topics: Arrhythmias and Clinical EP, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Atrial Fibrillation, ACC Advocacy, Heart Rate, Mobile Applications, United States Food and Drug Administration, Electrocardiography

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