Apple obtains FDA 510(K) clearance for a new AFib history feature for Apple Watch

fib history on Apple Watch with watchOS 9

Apple Inc has received FDA’s 510(k) clearance approval for a new feature coming to your Apple Watch. The Apple Watch, using watchOS 9 and above, can now keep track of a person’s Atrial Fibrillation history. 

The new filing has been made available today. Users in the US aged 22 years or older already diagnosed with AFib should be able to check their AFib history and more–a first for any wearable!

At this time, with watchOS 8 and below, Apple recommends people only use the ECG app and irregular rhythm notifications on the Apple Watch to identify potential signs of atrial fibrillation (AFib.) 

But with watchOS 9, Apple Watch users diagnosed with atrial fibrillation can use AFib History to monitor their condition. This feature estimates the time a user’s heart is in AFib and helps users stay informed about lifestyle factors that may influence AFib.

Afib history feature watchOS 9

An AFib result means the heart is beating in an irregular pattern. The ECG app ver. 1 can check for AFib between 50 and 120 BPM. The ECG app ver. 2 can check for AFib between 50 and 150 BPM.

AFib is the most common form of serious arrhythmia or irregular heart rhythm. If you receive an AFib classification and have not been diagnosed with AFib, you should talk to your doctor.

According to Apple, the ability of the ECG app to accurately classify an ECG recording into AFib and sinus rhythm was tested in a clinical trial of approximately 600 subjects. It demonstrated 99.6% specificity with respect to sinus rhythm classification and 98.3% sensitivity for AFib classification for the classifiable results.

According to Apple’s press release for watchOS 9, this new health feature does the following.

With watchOS 9, users who are diagnosed with AFib can turn on the FDA-cleared AFib History feature and access important information, including an estimate of how frequently a user’s heart rhythm shows signs of AFib, providing deeper insights into their condition. Users will also receive weekly notifications to understand frequency and view a detailed history in the Health app, including lifestyle factors that may influence AFib, like sleep, alcohol consumption, and exercise.
 
Users can download a PDF with a detailed history of their AFib and lifestyle factors, which can easily be shared with doctors and care providers for more informed conversations.

This new feature should be available in September with the public release of watchOS 9.

I am a technologist with years of experience with Apple and wearOS products and have a Bachelor’s degree in Computer Science. In my day job, I advise fortune 500 companies with their digital transformation strategies and also consult with numerous digital health startups in an advisory capacity. I'm VERY interested in exploring the digital health&fitness-tech evolution and keep a close eye on patents, FDA approvals, strategic partnerships and developments happening in the wearables and digital health sector. When I'm not writing or presenting, I run with my Apple Watch or Fossil Gen 5 LTE and keep a close eye on my HRV and other recovery metrics.

2 COMMENTS

  1. The 510(k) process is not considered an “approval”. Devices are “cleared” through the 510(k) process.

    “Approvals” are limited to the higher risk devices and indicates a much higher level of review by the FDA through the Premarket Approval (PMA) process.

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