Garmin’s ECG app cleared for US market by FDA
Garmin has received Food & Drug Administration (FDA) approval for a ECG app. This opens the door for the company to sell devices with this feature in the United States.
It has been nearly a year since ECG was first discovered in a Garmin watch. An early firmware version on Venu 2 Plus supported rudimentary ECG measurements. Because that software was not meant for public consumption, the feature has been pulled from subsequent firmware versions. We now have a possible explanation as to why we have not seen a Garmin watch with ECG yet.
Essential reading: Keep tabs on your heart – wearables the come with an ECG sensor
Obtaining FDA approval for ECG in the United States can be a time-consuming process. ScanWatch, for example, was released in Europe by Withings in 2020. However, the device was not approved for sale in the United States until a year later. That is how long it took the French company to obtain FDA approval. Garmin may have encountered similar issues.
Garmin now has FDA approval for an ECG tracking watch
According to FDA documentation, the application was received on June 21, 2022. This year, it was only approved on January 12th. It says Garmin ECG app under device name. We’re not sure if this means there will be a separate app for ECG readings in addition to Garmin Connect. Alternatively, whether everything will be integrated into Connect.
Garmin has been working on ECG for quite some time. It is a test that is used to assess the rhythm and electrical activity of your heart. The technology is frequently used to detect symptoms of a potential heart problem, such as arrhythmias, coronary heart disease, heart attacks, and cardiomyopathy.
Previously, ECGs could only be obtained in medical settings or by purchasing a large machine. In recent years, however, this has shifted. The Apple Watch is credited with popularizing home-ECG monitoring. Other manufacturers’ devices, such as Withings, Fitbit, and Samsung, have recently joined the club.
Garmin launched a Clinical Trial in April 2021 to determine the efficacy of its proprietary ECG technology. The study is described in this manner in the US National Library of Medicine. It discusses a single-lead ECG device, which is a Garmin “wrist-worn, consumer device” capable of detecting and classifying normal sinus rhythm and atrial fibrillation.
Interestingly, a USPTO patent was made public on June 17th 2022 (number 11350869). It describes a Garmin watch that can take ECG measurements. That patent was published less than a week after Garmin’s FDA submission.
Not clear yet which Garmin devices will be able to measure ECG
What we don’t know yet is which Garmin devices will be capable of measuring ECG. The Venus, presumably, should be on this list. The question now is whether Garmin will make the feature available for older devices. This could also include the most recent Fenix watches and Epix 2. Who knows, maybe even the top-tier Forerunners can take such readings.
There is also talk of the Vivomove Trend, Forerunner 265, and Forerunner 965 being released soon. We don’t expect the first of these to be able to take ECG measurements, but the other two might.
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