The Apple Watch’s atrial fibrillation (AFib) history feature initially resonated with people who wanted to monitor their heart health at home. Now, the feature could find a second wind in clinical settings. According to a review by the US Food and Drug Administration (FDA), the wearable is considered dependable enough to be used in medical device research.
The FDA offered the green light under its Medical Device Development Tools (MDDT) program, allowing the organization to qualify technologies that support creating safe and effective medical devices. Whether it's a piece of software, a new testing method, or a novel medical sensor, vetted tools are added to the FDA's MDDT database. Using MDDTs from the database allows medical device developers to streamline the approval process for their inventions, as the FDA no longer needs to verify the safety and efficacy of the methods upon which those devices were built.
According to the FDA, the Apple Watch AFib history feature offers "scientifically plausible measurements," allowing it to receive the MDDT go-ahead. As a qualified MDDT, the feature can now reliably be leveraged throughout clinical research to support the development of new arrhythmia-related medical tools. Wednesday's announcement specifies that the feature can be used as a biomarker test that measures a person's AFib burden—or the extent to which they experience irregular heartbeat—before and after new AFib interventions. Such interventions often involve cardiac ablation (the use of scar tissue to restore a normal heartbeat), though they can also include oral medications, frequent exercise, and reduced alcohol intake. Using the Apple Watch AFib history tracker, researchers can judge how effective their proposed intervention is among clinical study participants.
Apple's wearable is the first "digital health technology" to qualify for the MDDT program. An alternative to implanted monitors or so-called Holter monitors, which rely on multiple wires strapped to a person's chest, the Apple Watch could provide researchers with a comfortable, non-invasive way to track study participants' heart health. The FDA's secondary approval is a notch in Apple's belt as the company shakily works to build on its wearable's health features.
