Fitbit obtains 510(k) approval for irregular rhythm notifications

Last week, Fitbit obtained FDA approval for its irregular rhythm notifications feature. Fitbit will be the third smartwatch maker after Apple and Samsung to feature this set of cardio health features on a smartwatch.

Fitbit’s ECG app got a green light from the U.S. Food and Drug Administration (FDA) in 2020 and the EU’s CE mark.

The regulatory approval in 2020 opened up the capability for its ECG app to track users’ heart rhythms for signs of atrial fibrillation.

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Currently, your Fitbit Charge 5, Sense, and Versa 3 include high and low heart rate notifications.

When your heart rate is outside your high and low thresholds for at-least ten minutes when you are sedentary, you get a notification showing this abnormal reading on your device.

For irregular rhythm detection, such as AFib, you have to open up the ECG app on your Fitbit device and let it run the process to and current temperature on Fitbit clock face

The irregular rhythm notification feature on your Apple Watch occasionally checks your heartbeat to analyze for an irregular rhythm that might be suggestive of atrial fibrillation (AFib).

It is unclear from the regulatory filing which devices from Fitbit will feature irregular rhythm notifications and what kind in the future.

According to the CDC, approximately 2% of people younger than 65 years old and 9% of people 65 and older have AFib. Irregularities in heart rhythm become more common as people get older. 

Some individuals with AFib don’t experience any symptoms. Others experience symptoms that could include rapid heartbeat, palpitations, fatigue, or shortness of breath.

AFib can be temporary or persistent, and people with AFib often live healthy, active lives. AFib episodes can be prevented through regular physical activity, eating a heart-healthy diet, maintaining a healthy weight, and treating other medical conditions that could worsen AFib.

From last week’s approval, it is unclear if the approval is for a set of changes to the existing Fitbit Algorithms or if Fitbit is introducing new features to its devices in the upcoming months.

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Sudz Niel Kar
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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