The FDA today announced that it has qualified the Apple Watch AFib ( Atrial Fibrillation) history feature as an MDDT (Medical Device Development Tools). Apple’s Afib history feature becomes the first digital health technology qualified under MDDT to provide a non-invasive way to check estimates of AFib burden.
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).
Related Reading:
- Apple obtains FDA 510(K) clearance for a new AFib history feature for Apple Watch
- Apple and Johnson & Johnson to evaluate risks of blood clotting for Afib patients
- New Mayo Clinic study shows Apple Watch can help detect a potentially life-threatening heart condition
- Your health data on the Apple Watch – do you know the apps and services using it?
The MDDT program is a way for the FDA to qualify tools that medical device sponsors can choose to use in the development and evaluation of medical devices.
Tools such as biomarker tests, clinician-reported outcome measures, or computational models, and digital health technologies like sensors or wearables, play an important role in helping the FDA understand how medical devices work, in terms of safety, effectiveness, and other aspects of performance.
The stringent FDA process for MDDT qualification evaluates the tool and available supporting evidence to determine whether it can be used as intended to produce scientifically plausible measurements within a specified context of use.
According to the FDA announcement, Apple’s Atrial fibrillation history feature is:
- The first digital health technology qualified under the MDDT program, providing a non-invasive way to check estimates of atrial fibrillation (AFib) burden within clinical studies.
- Designed to be used as a biomarker test to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and effectiveness of cardiac ablation devices to treat.
- Designed to be used throughout the clinical study, both before and after cardiac ablation devices, to monitor a study participant’s weekly estimate of AFib burden.
The two programs / tools approved this year (2024) by FDA for MDDT focus on Arrhythmia features.
More importantly, the Apple Watch is the first device within the smartwatch product category to obtain a MDDT device classification by the FDA.
