Apple obtains 510(K) FDA clearance for its new IRNF app ( AFib Refinements) for Apple Watch

place finger on Apple Watch digital crown to get an ECG recording

Apple has obtained FDA regulatory clearance for a new ImF Photoplethysmograph analysis app this week that assists with irregular heart rhythm detection on Apple Watches.

The FDA branded the device name on the approved 510(k) as an IRNF app and falls in the Cardiovascular medical specialty area.

The Regulatory approval for the app was supported with clinical trials NCT04699812.

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About Apple’s FDA regulatory clearance for ImF Photoplethysmograph analysis

Apple Watch afib detection new features approved by FDA
Apple’s new IRNF app approved by FDA

Interestingly, when you scan the clinical trials datasheets, it appears that Apple has withheld the information from being public. The clinical trial documentation associated with this has been temporarily put on hold pending FDA approval.

The date when Apple received the application was 08/10/2021 (August), and the decision date on the app from FDA is 10/22/2021 (October).

Given that this is a photoplethysmograph analysis software for over-the-counter use, as suggested in the filings, Apple should roll out this new feature to Apple Watch users shortly.

It is unclear from the regulatory approval if the IRNF feature for the Apple Watch is a brand new feature or a refinement of the older ECG and AfiB algorithms.Apple Watch FDA Approval

However, the filing documentation suggests that this new approval is for the refinement/introduction of new Afib detection features. New study results from Apple Heart Study have shown that the Apple Watch software can detect other arrhythmias other than Afib.

Apple has in the past refined the software, and we had seen version 2 of the aFib software in Dec’ 2020 when the company adjusted the atrial fibrillation (Afib) software to help detect Afib at high heart rates.

The new Apple Watch Series 7 did not incorporate any new sensors from a health and wellness perspective, so we don’t expect a brand new feature via this latest FDA approval.

We haven’t seen any new announcements from Apple regarding this recent FDA approval for its Apple Watch software.

Source: FDA Approvals

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.

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