Apple receives FDA 501(K) for the latest version of their Irregular Rhythm notification feature

Apple Watch Afib Feature

Apple has received FDA’s 501(k) clearance for its new Irregular Rhythm Notification feature algorithms (IRNF).

The update to FDA was presented in April and was approved last week.

Apple provided guidance around ECG and Afib to its customers in Dec 2018. The irregular rhythm notification feature on Apple Watch can now also occasionally check heart rhythms in the background and send a notification if an irregular heart rhythm that appears to be atrial fibrillation (AFib) is identified.

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Apple worked with the Food and Drug Administration (FDA) for a number of years to receive the De Novo classification for the ECG app and the irregular heart rhythm notification, making the features available over the counter.

Apple Watch Irregular heartbeat detection Update at FDA
Apple’s latest changes to IRFN were approved by FDA in July 2023

It is not clear as to what the changes are in the Irregular rhythm notification feature. We haven’t seen any announcements from Apple or additional documents that guide the change.

It is possible that the Apple Watch AFib and IRNF algorithms have been updated with capabilities to detect other kinds of arrhythmias. The other possible update is perhaps related to high and low ranges for the detection of irregular rhythm notification features.

We bring this up since many of the motion algorithm-related efforts have been focused on this as per the numerous clinical trial proceedings that have been focussed on the Apple Watch. Apple and other entities, such as Mayo Clinic, have been doing some very interesting work regarding the ECG and Afib algorithms of the Apple Watch.

Although Apple regularly updates its watchOS algorithms, we are unsure how that impacts researchers’ work with the Apple Watch. One would have to believe that it ends up causing some short-term frustration on the researchers’ end, as they have to reconcile the data between the old algorithms and the new ones. 

That being said, Apple is one of the only leading wearable makers that has been successfully updating their algorithms and getting subsequent FDA approvals. We haven’t seen too many updates from Samsung or Garmin when it comes to their ECG/Afib notification features.

Please let us know if you have any questions. For the time being, we will wait for the Apple announcements to see if they are rolling out any new cardio health features when it comes to the IRNF features.

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I am a technologist with years of experience with Apple and wearOS products, have a BS in Computer Science and an MBA specializing in emerging tech, and owned the popular site AppleToolBox. 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 and fitness-tech evolution and keeping 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 Ultra or Samsung Galaxy Watch and closely monitor my HRV and other recovery metrics.


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