Fitbit finally wins regulatory clearance for Afib (Atrial Fibrillation) in US and Europe

Fitbit sense health tracking

Fitbit has finally received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as Conformité Européenne (CE) marking in the European Union, for its electrocardiogram (ECG) app to assess heart rhythm for atrial fibrillation (AFib).

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About Fitbit’s ECG app 

“Helping people understand and manage their heart health has always been a priority for Fitbit, and our new ECG app is designed for those users who want to assess themselves at the moment and review the reading later with their doctor,” said Eric Friedman, Fitbit co-founder, and CTO.

“Early detection of AFib is critical, and I’m incredibly excited that we are making these innovations accessible to people around the world to help them improve their heart health, prevent more serious conditions and potentially save lives.”

Fitbit Sense is the company’s first device compatible with an ECG app that enables users to take a spot check reading of their heart that can be analyzed for the heart rhythm irregularity AFib.

Users simply hold their fingers to the stainless steel ring on the watch while being still for 30 seconds to get a reading that can be downloaded and shared with a doctor.

The Fitbit Sense also features the company’s new PurePulse 2.0 technology

This new technology uses an all-new multi-path heart rate sensor and improved algorithm. This enhanced technology provides users with on-device and in-app notifications if their heart rate goes above or below their set heart rate threshold. Users who receive a notification can also take a survey in the Fitbit app to share with their doctor.

The new Fitbit Sense is available for $329.95 (USD) in carbon/graphite stainless steel and lunar white/soft gold stainless steel and can be ordered today from the company’s website.

Apple and Samsung (Galaxy Watch 3) have already won regulatory approvals for featuring aFib monitoring (as well as ECG features) on their smartwatches.

Another smartwatch maker waiting for regulatory clearance is the much anticipated Withings Scanwatch. What started out as an Apple Watch innovation is currently becoming a mainstream feature among other smartwatch makers. 

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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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