Garmin’s ECG app approved by FDA and will soon be featured on its Smartwatches

Garmin received FDA clearance for its electrocardiograph software for over-the-counter use this week. According to the filing, the application from Garmin was received last year in June and was approved this week by the FDA.

This makes it official! Garmin’s smartwatches can now feature an FDA-approved ECG feature.

Related reading:

Garmin joins a select group of wearables that offer an FDA-cleared ECG feature

Apple was the first company to receive ECG clearance in 2018. Following Samsung and Fitbit, Garmin now joins the wearable makers in offering this novel smartwatch feature.

Recent Garmin patents (#11350869 published on June 7, 2022) offer some insight into how Garmin plans to introduce this feature in its smartwatches.

According to Garmin’s current FDA filing, it is unclear if the company attempted at getting clearance for Afib detection or if there are other filings in the pipeline for heart health.

Garmin ECG app approved by FDA

Garmin dominates the high-priced athlete-focused smartwatch market

Although Apple dominates the Smartwatch market with a 36.1% market share, closely followed by Samsung at 10.1%, Counterpoint research estimated in 2022 that Garmin actually has the greatest share of the high-priced smartwatch market where smartwatches retail for more than $500.

Apple’s latest Ultra series of Apple Watches were specifically designed to address this lucrative market where Garmin has been a leader.

Although the Apple Watch Ultra is a fantastic smartwatch with many bells and whistles, it still is missing features that are a must-have for outdoor athletes, such as offline TOPO mapping and a battery life that lasts more than a week.

There have been rumors that Apple is working to expand the battery life of the next Ultra by switching over to microLED display devices. That being said, Garmin’s ECG win could be a huge change catalyst in the smartwatch market positioning.

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.

4 COMMENTS

    • Hi Joshua,

      We don’t yet know yet what current and upcoming models will support ECG. We are waiting for Garmin’s official announcement which will outline the feature rollout.

  1. I think this is a good future but it would more useful if Garmin spend more time to work on connecting 2 really expensive devices ( the Fenix 6 with Edge 1030 plus) to allow showing my activities and calculating my fitness as one.

    Which I think is more important than ECG monitoring.

    I’m a doctor and know that if someone has ECG significant abnormalities, they are symptomatic, and they do visit A&E. Therefore, I can’t see the point of celebrating extra things when we are missing the basics.

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