Garmin expands ECG App to customers in Australia and the European Union

Rhea-AI Summary

Garmin (NYSE: GRMN) has expanded its ECG App availability to customers in Australia and the European Union for compatible smartwatches, including Venu 3 Series and fēnix 8 Series. The app enables users to record 30-second ECGs and check for atrial fibrillation (AFib) signs directly from their smartwatch.

This marks Garmin's first smartwatch feature classified as a medical device in these regions. Users can view results immediately on their watch or through the Garmin Connect smartphone app, where they can also create shareable healthcare provider reports. The ECG App is specifically designed for adults aged 22 and over, functioning similarly to a Lead I ECG for detecting AFib or normal sinus rhythm.

The company plans to expand both its portfolio of ECG-compatible products and regional availability pending regulatory approvals. The feature requires the latest version of Garmin Connect app and smartwatch software.

Positive

• First Garmin smartwatch feature classified as a medical device in Australia and EU
• Expansion into new markets with medical-grade technology
• Integration with Garmin Connect app for comprehensive health tracking and reporting

Negative

• to users aged 22 and over
• Availability restricted to specific smartwatch models
• Requires regulatory approval for further market expansion

Customers can now record an ECG and check for signs of atrial fibrillation right from their compatible Garmin smartwatch

OLATHE, Kan., Jan. 15, 2025 /PRNewswire/ -- Garmin (NYSE: GRMN) today announced the ECG App is now available to customers in Australia and the European Union with a compatible Garmin smartwatch, including Venu^® 3 Series, fēnix^® 8 Series and more^1,2. The ECG App allows users to record their heart rhythm and check for signs of atrial fibrillation (AFib) whenever they want. Customers can use the ECG App to record a 30-second ECG and view their heart rhythm results immediately on the watch or, optionally, later in the Garmin Connect^™ smartphone app. 

"The ECG App is Garmin's first smartwatch feature categorized as a medical device in Australia and the European Union, and we are thrilled to offer this revolutionary tool to more customers as another way to stay on top of their health. During the early stages of AFib, it's common for symptoms to be infrequent, making it difficult to detect in a clinical setting. With the ECG App, customers can conveniently take an ECG recording when they want and optionally create a report of their results to share with their doctor later."
—Dan Bartel, Garmin Vice President of Global Consumer Sales

When customers take an ECG, the ECG App uses sensors on a compatible Garmin smartwatch to record the electrical signals that control how their heart beats. The ECG App then analyzes that recording to detect signs of AFib. Additionally, users have the option to sync their ECG App results to Garmin Connect. Through the Garmin Connect app, customers can view their history of ECG App results and create reports that can be shared with a healthcare provider. 

Following the recent achievement of regulatory authorizations in the European Union and Australia, the ECG App is now available for customers in these regions and requires the latest version of the Garmin Connect app and smartwatch software before use. Garmin intends to continue to expand its portfolio of products supporting the ECG App and launch it in new regions in-line with necessary regulatory approval. For more information on the ECG App and how to set it up, visit Garmin.com/ECG.

Engineered on the inside for life on the outside, Garmin products have revolutionized the health and wellness industry. Committed to developing smart watches and health measurement tools that help people of all activity levels lead healthier lives, Garmin believes every day is an opportunity to innovate and a chance to beat yesterday. For more information, visit Garmin's virtual newsroom, email our press team, connect with @garminfitness on social media, or follow our adventures at garmin.com/blog.

1

The ECG app is capable of recording an ECG similar to a Lead I ECG and detecting the presence of atrial fibrillation or normal sinus rhythm. The ECG app is only intended for adults aged 22 years and over. The ECG app is not intended to replace traditional methods of diagnosis or treatment. If atrial fibrillation is detected, consult a doctor. If you experience symptoms of a heart attack, stroke, or other cardiovascular conditions, do not rely on the notification of the device and consult a doctor. Always follow the instructions for use. The ECG app is not available in all regions and is only available on select Garmin smartwatches with the latest version of the Garmin Connect smartphone app and watch software. See Garmin.com/ECG for availability and full instructions for use. The ECG app is a Class IIa medical device under the EU Medical Device Regulation (MDR) (EU) 2017/745.

2

Visit Garmin.com/ECG  for a full list of compatible devices.

About Garmin International, Inc. Garmin International, Inc. is a subsidiary of Garmin Ltd. (NYSE: GRMN). Garmin Ltd. is incorporated in Switzerland, and its principal subsidiaries are located in the United States, Taiwan and the United Kingdom. Garmin, Venu and fēnix are registered trademarks and Garmin Connect is a trademark of Garmin Ltd. or its subsidiaries. All other brands, product names, company names, trademarks and service marks are the properties of their respective owners. All rights reserved.

Notice on Forward-Looking Statements:
This release includes forward-looking statements regarding Garmin Ltd. and its business. Such statements are based on management's current expectations. The forward-looking events and circumstances discussed in this release may not occur and actual results could differ materially as a result of known and unknown risk factors and uncertainties affecting Garmin, including, but not limited to, the risk factors listed in the Annual Report on Form 10-K for the year ended December 30, 2023, filed by Garmin with the Securities and Exchange Commission (Commission file number 0001-411180). A copy of such Form 10-K is available at http://www.garmin.com/aboutGarmin/invRelations/finReports.html. No forward-looking statement can be guaranteed. Forward-looking statements speak only as of the date on which they are made and Garmin undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

MEDIA CONTACTS:
Stephanie Kelner
913-397-8200
media.relations@garmin.com

 

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SOURCE Garmin International, Inc.

FAQ

Which Garmin smartwatch models support the new ECG App in Australia and EU?

The ECG App is compatible with the Venu 3 Series and fēnix 8 Series smartwatches, among others. A full list of compatible devices can be found at Garmin.com/ECG.

How does the GRMN ECG App function on compatible smartwatches?

The app records a 30-second ECG using smartwatch sensors to analyze electrical signals controlling heart beats, checking for signs of atrial fibrillation or normal sinus rhythm.

What are the age restrictions for using Garmin's ECG App?

The ECG App is only intended for adults aged 22 years and over.

Can GRMN smartwatch ECG results be shared with healthcare providers?

Yes, users can create reports of their ECG results through the Garmin Connect app to share with their healthcare providers.

What medical device classification does GRMN's ECG App hold in the EU?

The ECG App is classified as a Class IIa medical device under the EU Medical Device Regulation (MDR) (EU) 2017/745.