Apple Watch Ultra 2 is one of the devices with AFib history.
The Apple Watch has long had a strong focus on health and wellness. In the last few days, the FDA has just announced that it has qualified one feature, the Atrial Fibrillation history feature as a Medical Device Development Tool.
This kind of MDDT device classification for the Watch is a first, making it the first ever digital health technology to qualify. It means the Apple Watch can soon be used in clinical trials, for a start.
According to the reliably informative My Healthy Apple, the qualification means that the Watch is recognized “to provide a non-invasive way to check estimates of AFib burden.”
The FDA’s statement described it as the first digital health technology qualified under the MDDT program.
When users take an ECG on the Apple Watch, it deduces whether you have AFib or not. The AFib history feature records the wearer’s heart events and means users diagnosed with atrial fibrillation can view an estimate of how frequently their heart is in this type of irregular rhythm.
The report explains, “The AFib History feature analyzes pulse rate data collected by the Apple Watch photoplethysmography (PPG) sensor to identify episodes of irregular heart rhythms consistent with AFib and provides the user with a retrospective estimate of AFib burden (a measure of the amount of time spent in AFib during past Apple Watch wear).”
This means the Watch can be used as a biomarker test, “to help evaluate estimates of AFib burden.”
The FDA is saying that the Apple Watch is now usable in clinical studies. As the report says, it means it is “Designed to be used … both before and after cardiac ablation devices, to monitor a study participant’s weekly estimate of AFib burden.”
Two programs have been approved for this year, with a focus on arrhythmia, or irregular heartbeats.
The FDA process is a stringent one and evaluates supporting evidence to determine accuracy and whether it can be used for scientifically plausible measurements within a context. As such, it’s a real feather in Apple’s cap.