Apple Watch AFib History Feature Receives FDA Qualification for Evaluating Medical Devices


Apple’s atrial fibrillation (AFib) history feature on the Apple Watch has achieved qualification from the FDA under its Medical Device Development Tools (MDDT) program, marking a significant milestone as the first digital health technology feature of its kind to receive such recognition.

Since 2022, Apple Watch has provided support for AFib History, allowing users diagnosed with atrial fibrillation to access an estimate of the frequency of irregular heart rhythms. This feature utilizes pulse rate data collected by a photoplethysmography (PPG) sensor to identify episodes consistent with AFib, offering users a retrospective estimate of AFib burden—measuring the amount of time spent in AFib during past Apple Watch usage. It is intended for individuals aged 22 years or older who have received a diagnosis of atrial fibrillation.

Prior to its public announcement by Apple, the AFib History feature received FDA clearance in the United States after undergoing validation in a clinical study. The MDDT program, under which the feature obtained approval, serves as the FDA’s mechanism for qualifying tools that medical device sponsors may employ in the development and evaluation of medical devices.

As outlined by the FDA, the Atrial Fibrillation History feature holds the following distinctions:

  1. First Digital Health Technology Qualified Under the MDDT Program: This feature provides a non-invasive method for assessing estimates of atrial fibrillation (AFib) burden within clinical studies.
  2. Intended Use as a Biomarker Test: It serves as a tool to aid in evaluating estimates of AFib burden as a secondary effectiveness endpoint within clinical studies focused on assessing the safety and effectiveness of cardiac ablation devices for treatment.
  3. Utilization Throughout Clinical Studies: The feature can be utilized throughout the clinical study process, both before and after the implementation of cardiac ablation devices, to monitor a study participant’s weekly estimate of AFib burden.

The qualification of Apple’s AFib History feature underscores the growing role of digital health technologies in facilitating medical research and enhancing patient care.