FDA Approves Apple Watch Software for use in Clinical Trials

The FDA granted the Apple Watch the go-ahead to use its atrial fibrillation tracking capabilities in clinical trials. 

As an additional efficacy goal, the Apple Watch may now be used to measure an individual’s frequency of arrhythmia, for example, following a cardiac ablation treatment to fix the abnormal heartbeat. 

 
Apple has named this programme AFib History, which attempts to provide an overarching view of the duration of cardiac arrhythmias. The wearer’s heart rate is monitored on a regular basis, and the results are graphed with data on sleeping, physical activity, and alcohol intake.  

Rather than sending out notifications for specific AFib events, the programme sends out a weekly summary. 

As stated by the FDA, “The AppleAFib History Feature can help address the challenges of patient compliance, potential placebo effects, and the technical difficulties without an implantable device by allowing for passive, opportunistic AFib burden estimation in a wearable form that is already familiar to Apple Watch users.”