Garmin has recently announced that customers in the United States can now benefit from Electrocardiogram (ECG) capabilities on the Venu 2 Plus watch.
The FDA finally approved the inclusion of an Garmin ECG (electrocardiogram) feature in wearable devices last month, following years of research and testing in clinical settings.
Garmin has taken the lead by being the first company to release a watch equipped with this technology. The continuous ECG monitoring functionality can detect and classify both atrial fibrillation (AFib) and normal sinus rhythm.
At any moment, you can launch the ECG app on your Venu 2 Plus, tap the bezel using your fingertips, and then wait for the ECG to finish in around 30 seconds. Your results will then be available, and you can print them out or save them as a PDF to take to your doctor.
Requirements and Specifications
For the ECG app to work efficiently on your device, you require a Garmin Venu 2 Plus watch. Garmin has stated that this is their only watch, including the required hardware for an ECG.
The hardware consists of a wire connected to the bezel of the watch and an electrode made of metal that surrounds the optical HR sensor and is electrically connected.
The Venu 2 Plus hardware features a unique metal sensor consisting of an electrode and a backplate separated by an isolation/insulating ring. This configuration is necessary for the watch to accurately measure ECG readings by completing the electrical circuit.
The internal wire connecting the antenna is concealed, but the thin insulating sheet surrounding the electrode sensor is visibly present on the device.
The following caveat is that your initial use of the ECG app requires you to be physically present in the United States.
You must update your Garmin Connect Mobile app and Venu 2 Plus’s firmware to the most recent versions. The names of the variants are:
- A minimum of Garmin Connect Mobile 4.62 (iOS/Android).
- We recommend using Firmware 11.21 or later for the Garmin Venu 2 Plus.
Garmin ECG: Getting Started
First, get your watch ready for ECG use by turning on its related features. You’ll need to download the Garmin Connect Mobile app on your smartphone to get started.
That’s because Garmin checks your phone’s GPS and Wi-Fi signals to ensure you are in the United States. Once activated, usage outside the US is permitted without further action on your part.
You might have to do this if you’re setting up a brand-new watch. You won’t be prompted to set it up if it’s for a new watch. Once you click that, it will explain briefly what an ECG is and isn’t. It does not, for instance, recognize cardiac attacks.
Being an OTC medical device, the FDA stipulated these conditions for clearance. Therefore, the device’s instructions must be comprehensive enough for the user to understand what they need to know.
This means that no doctor or pharmacist consultation is assumed. It also verifies that you’re at least 22 years old.
How Garmin ECG Works?
You will find the ECG option after scrolling through the app icons. You can check the options and information related to EGC here. Place your thumb and index finger on the metal ring/bezel as you rest your other arm with the watch on a table. You must wear your Garmin on the same wrist you designated in Garmin Connect Mobile.
After a little delay, the ECG will begin, and you’ll wait another 30 seconds. While you wait, the waveform, your heart rate, and a timer will all be displayed in real-time. A failure warning will appear if you make too large of a movement or do something else that can’t be explained.
Following completion, the outcome will be provided instantly. All of this takes place on the watch itself, without the need for any external connections. To further explore your symptoms, you can use the results to scroll left and right along the waveform.
Watch this video for more details.
These recorded symptoms and complete results are subsequently synced to the watch and Garmin Connect alongside the relevant ECG result. However, you can view the complete ECG readings, including the previous ones, on Garmin Connect Mobile and even print out a PDF to bring to your doctor or share on social media.
And there you have it; it is that easy. Its inherent straightforwardness is an intentional design feature. The whole point of having something as a regulated OTC medical device is that it is extremely difficult, if not impossible, to mess up. In that vein, let’s go right into the FDA details.
Garmin ECG Approval requirements
The process required Garmin to clear three Important requirements essentially:
1. How well did it perform in clinical trials, and did those results satisfy the Food and Drug Administration’s standards?
2. Usability in the hands of the average person who has never used the product before, based solely on the on-screen and app-based documentation provided. This is significant because it is a nonprescription product.
3. The algorithm’s technical performance is assessed by looking at how well it copes with various technical challenges, including heat, EMI, arrhythmia, and more.
FDA Approval Background for Garmin ECG
It’s important to briefly digress and discuss the ECG App’s clinical testing and FDA clearance. Garmin tested its ECG app in clinical settings, and everyone can see this information. Everything from the tests to the testing infrastructure, user volume, and procedures. Garmin uses its legal business name while making these filings. On the contrary, Apple was the first company to offer a product in a watch form factor; thus, keeping their development under wraps was crucial from a strategic standpoint.
Without getting too technical, Garmin had planned to have 460 participants in the trials but ended up with 568. Some participants initially included in the study were dropped for various reasons.
This could be either a flaw in the sampling procedure or the participant did not meet the criteria. To compensate for potential dropouts later in the study, increasing the number of participants is necessary. It’s expected that the actual total will be higher than the original estimate.
From the perspective of official clinical studies, this entire procedure began in April 2021. But it was only when the first publicly available documentation was submitted; the actual engineering and planning had already begun long before that.
The final FDA approval for Garmin ECG is now complete. The full summary of Garmin’s report, which will provide us much more facts, will be published by the FDA next month.
Limitations of Garmin ECG
The Venu 2 Plus is not intended for use as a medical device, and it is important to note that Garmin has not issued any such certification for the product.
Instead, they are approving the “ECG App” that runs on the Venu 2 Plus, and they are particularly demonstrating to the FDA that it was “substantially identical” to an already approved device.
Here, Garmin was trying to show that its approach was functionally equivalent to Apple’s.
Within that scope, Garmin is solely concerned with ECG efficiency. This does not include testing Garmin health features like PulseOx (SpO2 sensing), heart rate monitoring while exercising, automatic sleep tracking, or any others.
The ECG feature, exclusively and more narrowly, is the ability to recognize and distinguish between atrial fibrillation and normal sinus rhythm.
Summary
Fortunately, similar to Apple and other companies, Garmin will continue to introduce new watches equipped with ECG hardware. This feature is activated in each location when approval is granted.
The same holds with the Venu 2 Plus. When Garmin receives EU (or another country) permission in the future, it will be simple to enable EU support for watches that currently have the necessary hardware.
