Wearable brand Garmin is actively researching whether its smartwatches can be used to track ECG and atrial fibrillation (Afib). Results of the Clinical Trial are expected in July.
What is an ECG?
An electrocardiogram (ECG) is a test that is used to check the health of your heart’s rhythm and electrical activity. The tech is often used to diagnose symptoms of a possible heart problem, such as arrhythmias, coronary heart disease, heart attacks and cardiomyopathy.
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In the doctors office, a test involves attaching a series of electrodes to your arms, legs and chest. These sensors lead from your body to an ECG recording machine.
Previously you could only take ECGs in medical settings or by purchasing a bulky machine. That has changed in recent years. You could say, home-ECG monitoring has been popularized by the Apple Watch. Series 4 and above come with the tech built in allowing anyone to keep an eye on their heart health from the comfort of their living room.
This works on demand. Users are meant to launch the ECG app and rest their finger against the digital crown on the Apple Watch. This creates a closed circuit with the sensor on the back and then the electrodes work in tandem to capture electrical impulses from the heart.
But Apple is not the only wearable brand with ECG monitoring. There are others such as Withings, Fitbit and Samsung, plus a number of less well known options.
What you’ll notice is that Garmin is not on this list. Unlike some other wearable brands, Garmin has not yet integrated ECG into its products. Well, that might be about to change.
Garmin is working on a single-lead ECG device
In April this year, Garmin has launched a Clinical Trial to determine whether its proprietary ECG technology is any good. This is how the study is described in the US National Library of Medicine.
“The purpose of the study is to confirm the Garmin ECG (electrocardiogram) software algorithm can detect and classify atrial fibrillation and normal sinus rhythm on single lead ECG data derived from a Garmin wrist-worn, consumer device.
The study will also confirm the software’s ability to create a Lead I ECG that is clinically equivalent to a reference device. The Garmin ECG software is not a diagnostic system and is intended for informational purposes only.”
The most interesting part of this description is that it clearly states the single-lead ECG device is a Garmin “wrist-worn, consumer device”. Single lead data is what is typically derived from smartwatches with ECG technology. This is less accurate than 12-lead ECGs, which is what you typically get in a medical setting.
Nevertheless, studies have shown that single-lead smartwatches do a decent enough job when measuring ECG from the wrist. One such study published in BMJ Journal shows that such wearables offer “moderate diagnostic accuracy when compared with a 12-lead ECG”. And suggest that “physician involvement will likely remain an essential component when exploring the utility of these devices for arrhythmia screening.
Looking out for Afib
Garmin is testing whether its wearable can be used to detect and classify normal sinus rhythm and atrial fibrillation. The latter is an irregular heart rhythm and the most common type of arrhythmia. It effects about one in 18 people, or 5% of the US population.
Having Afib is only a part of the problem. The other part is that a lot of people don’t know they have it. Early identification is key so that you can head off any potentially life-threatening developments before they arise.
Some 460 people, 22 years and older, are participating in the study which Garmin plans to conclude in July. Some of these have specifically been recruited because they have a known history of atrial fibrillation. Others have no known diagnosis of any arrhythmia. All participants are equipped with a single-lead Garmin ECG-enabled wearable device and the results are being compared with a 12-lead ECG.
When could we see a Garmin watch with ECG?
Even if the trial is successful, that’s not the end of the road. Garmin will still need regulatory approval for such a wearable. In the US this comes from the FDA. Only then will it be able to launch a consumer device that can be used for self-monitoring ECG.
Withings has shown just how difficult it can be to get the stamp of approval from the FDA. It has secured the regulatory go-ahead for Scanwatch in Europe more than a year ago, but is still waiting for US approval.
We saw recent launches of the Garmin Forerunner 55 and Forerunner 945 LTE. Other watches that might land this year include the Garmin Vivoactive 5 and possibly the Forerunner 955. We don’t see the Fenix 7 landing before the start of 2022. Might some or all of these come with ECG? That’s quite possible.
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We are expecting the Vivoactive 5 to arrive in early autumn, ahead of the end-year holiday shopping period. The current version was launched in Q3 2019 so is well due for an upgrade.
In our mind, that watch alongside its more pricey sibling the Venu are ideal candidates for ECG monitoring as they are Garmin’s all-purpose watches. Whether we see the tech included this year depends on the results of the Clinical Trial and length it takes to get FDA approval.
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