Apple Watch AFib History Feature Qualified by FDA to Evaluate Medical Devices
Apple's atrial fibrillation (AFib) history feature on Apple Watch has been qualified by the FDA under its Medical Device Development Tools (MDDT) program, the first digital health technology feature of its kind to do so.

Since 2022, Apple Watch has supported AFib History, which allows users diagnosed with atrial fibrillation to view an estimate of how frequently their heart is in this type of irregular rhythm.
The feature analyzes pulse rate data collected by a photoplethysmography (PPG) sensor to identify episodes 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). Apple says the feature is intended for individuals aged 22 years or older who have been diagnosed with atrial fibrillation.
The AFib History feature received FDA clearance in the United States just prior to its announcement by Apple, after being validated in a clinical study. The MDDT program under which the feature was approved today is the FDA's method of qualifying tools that medical device sponsors can choose to use in the development and evaluation of medical devices.
According to the FDA, the 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.
(Via MyHealthyApple.com.)
Popular Stories
While the iPhone 17 Pro and iPhone 17 Pro Max are not expected to launch until September, there are already plenty of rumors about the devices.
Below, we recap key changes rumored for the iPhone 17 Pro models as of March 2025:
Aluminum frame: iPhone 17 Pro models are rumored to have an aluminum frame, whereas the iPhone 15 Pro and iPhone 16 Pro models have a titanium frame, and the iPhone ...
With the second release candidate of iOS 18.4 that Apple seeded out today, the company finally provided us with release notes that give a full rundown on what to expect.
There's an Apple Vision Pro app, new Apple Intelligence features for notifications and additional language support, plus an Apple News Food feature for Apple News+ subscribers, and several updates that should improve the...
Apple regularly refreshes the MacBook Pro models, and a new version that uses M5 series chips is in the works. Apple just finished refreshing most of the Mac lineup with M4 chips, and now it's time for the M5. Rumors suggest that we could see the first M5 MacBook Pro models this fall.
Design
There have been no rumors of a design update for the M5 MacBook Pro models that are coming this...
In the mid-to-late 2000s, Facebook was all about staying connected with friends and family. However, as the social media platform added new features and grew over time, that core experience began to get drowned out.
That changes starting now, according to Meta, which today introduced a new feature that will "bring back the joy" of classic Facebook.
Specifically, Meta has redesigned the...
Apple is reportedly working on a new Magic Mouse. Below, we recap what to expect.
The two key rumors for the Magic Mouse 3 so far include a relocated charging port, along with a more ergonomic design.
It was briefly rumored that the Magic Mouse 3 would also feature voice control, but that was misinterpreted information.
Relocated Charging Port
While the Magic Mouse switched from...
We've been hearing rumors about a foldable iPhone for almost a decade now, but it looks like we might finally see the device come to fruition in 2026. We're going to be waiting many more months for the foldable iPhone, but so far we're hearing good things.
Apple wants to make it creaseless. It's taken Apple multiple years to design a foldable iPhone that it's satisfied with because Apple ...
Apple's big developer event is a little over two months away, and rumors about what we can expect to see in Apple's next major operating system updates are becoming increasingly frequent.
A public release of iOS 18.4 is also imminent with a number of updates and improvements, although we won't be getting the major Apple Intelligence Siri upgrades that had reportedly been planned for this...
The upcoming iOS 18.4 update for the iPhone adds an Ambient Music feature to Control Center. Below, we take a closer look at how it works.
iOS 18.4 is currently in beta, so the Ambient Music feature is not widely available yet. The update will likely be released to the general public next week.
To use the feature on iOS 18.4, open Control Center and tap on the plus sign in the top-left...
Last week, we covered a report claiming that Apple's book-style foldable iPhone (or "iPhone Fold," as we are provisionally calling it here) will use liquid metal hinges to improve durability and help minimize screen creasing. Today, a Chinese leaker provided more details on the properties of this hinge material that help to clarify why Apple chose it for its first foldable device.
According...