Can Garmin watch do ECG?

Garmin watch; Today marks the first appearance of Garmin's new secret ecg functionality on their venue. 2 plus, at least on this venue 2 plus, it's probably not on your venue 2 plus, it used to be.

First, it's worth noting that this is the first time we've seen ecg on any Garmin device. Apple, Samsung, Fitbit, and everyone else has pretty much done ecg at this point.

Garmin watch Secret ECG Feature

This is the first time we've seen it on a Garmin device and seen it in action, but it's not the first time we've heard of Garmin ecg.

Indeed, last spring and summer, Garmin recruited approximately 500-600 people to participate in a study with their wearables, which was assumed to be the Venue 2 at the time or the Venue Series, using ecg and conducting that study in a very clinical manner.

Actually, it was filed as a clinical study for ecg and testing a couple of different things, including not only the accuracy compared to medical grade equipment, but also the identification of certain different patterns.

First, I thought I'd show you how this thing works, so I've got a Venue 2 Plus right here with the ecg app and an Apple Watch Series 7 over here with this ecg functionality, which I'm just going to show you here.

I'm going to go ahead and put the watch on, nothing crazy, nothing too tight or anything like that, just kind of like normal watch snugness.

If you will, it is worth noting that this is not the final ecg app, but rather one of the diagnostic and service menus. In fact, if I tap through the menus here, you can see the different ones for the display diagnostics and backlight, the gps test, and heart rate.

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As I shift, the accelerometer These are simply different menus on the watch amp plus and bluetooth smart, as well as the broadband altimeter, wi-fi, and optical heart rate nfc vibration.

I mean, it goes on and on and on, but eventually we get back to the ecg test right there this is the ecg diagnostic app and if I go ahead and touch it it will go ahead and start reading you have to give it a couple seconds to do that.

It will eventually stabilize, and as we can see, it has now stabilized and is showing my ecg. The challenge, of course, is that there is no way to save these results right now because, once again, this is a diagnostic app.

It was never intended to be seen by the general public, and in Garmin's ideal world, we would never have known about it because by the time you install final production software on this, it wipes us out of the challenge.

However, Garmin, like every other company, has to produce units ahead of time for many months prior to release in the case of the Venue 2 plus, which released the first week of January 2022, which means they were most likely building units for two to three months ahead of time.

Now, for whatever reason, they left this in the diagnostic menus during that time period, which means that on those units that were then shipped out to the rest of the world, that diagnostic menu is still present. 

So, when I bought this unit off the shelf like any other consumer, that diagnostic menu remained, at least until I updated the watch.

For the first time, once I update the watch, the diagnostic money vanishes like a fart in the wind, and you'd never know about it unless someone on Garmin's own forums posted back in the first week of February that they accidentally got into the menu on their watch and were trying to set up or something and they stumbled into this.

They didn't have any proof at the time, so they didn't publish anything about it. Of course, given the lack of photographic evidence, I did the only logical thing.

I could do it I went out and bought a brand new unit for science, I guess, and that's how I ended up here, so the question is, is this accurate? I don't know. 

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I'm not a cardiologist, but I can show you exactly what happens on the Apple Watch Series 7 and how it looks on that one, side by side.

So here's that watch, we'll go into the ecg menu there we go right there boom hold the finger on the crown and it starts then I mean the untrained eye here.

Obviously, Garmin's is the raw data and Apple's is the smooth data in this graph right here as well as the app around it, but the underlying structure of that particular pattern does look the same, and at the end of Apple's test state, I only show you that.

It's a normal sinus rhythm with no signs of afib, and then this data is saved into your phone, where you can send it to your doctor and all that kind of stuff, and those are pieces that inevitably garmin would have on their official app, which, again, this is not.

I want to say that several times because I know someone will look at this and say, "Oh, that doesn't look right; it's diagnostic data."

The point of this kind of thing is that it was just sort of accidentally left in there, and now we can poke at it and see what garments plans are now speaking of their plans, let's talk about that in relation to the study they did last summer.

So this study is completely visible within federal databases because I filed it there, as you can see it was first opened and submitted last april of 2021 over the course of the summer they recruited 568 people they originally planned only 460 people.

Then a portion of those would have afib and a portion would not, and they attempted to determine which were which within the study. 

This study clearly states what the purpose is, and I'll put it on the screen right now to confirm the garmin ecg software algorithm can detect and classify atrial fibrillation and normal sinus rhythm on a single lead ecg data derived from a garmin wristworn consumer device.

Then I'll compare that data to a known clinically validated device. Of course, this will almost certainly result in garments submitting paperwork to be certified as a medical device.

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Technically, these are part of the FDA's software as a medical device program, which means they can certify only a portion of it rather than the entire watch and all of its features. So they're only certifying, say, ecg functionality but not all heart rate bits or all blood pulsed oxygenation bits or all respiration rate just ecg. 

Anyway, back to this study, it was conducted with six different research partners over the course of last summer, and it was completed last fall.

For the time being, it only needs to state that the study exists. The next piece is the device itself, and Garmin cannot legally acknowledge the existence of a medical device that has not yet been approved in the United States.

That means that if they acknowledge the existence of that device prior to FDA approval, they will be in serious hot water, and we all know that Garmin is a very fiscally and legally conservative company, and there is no way they will upset any portion of that apple cart by even mentioning it.

This exists at all, and other companies, such as Apple and Fitbit, have announced the ecg capability after receiving FDA approval. 

Keep in mind that the clinical trial period lasted from last spring to last fall, and that this will eventually lead to an FDA submission and approval.

Then, once they have received final FDA approval from the government, they can acknowledge the existence of the device, as was the case with Apple in 2018. 

In their case, they received FDA approval about two weeks prior or so, and it took another few months before it was available on your watch.

If you look at the clinical trials conducted by Apple and Garmin, you'll notice that the average number of participants is between 550 and 600. 

Garmin's durations were slightly longer than Apple's, but that makes sense given that trying to recruit people in the middle of covid versus apples was in 2018, and an apple's case is about five months between the conclusion of their data gathering and their fda approval.

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So we don't know the exact timing of what happens within that window, but keep in mind that it was 2018 versus 2022, and things will undoubtedly take longer now than they did then.

Then it's important to remember that we may never see ecg on the venue two plus, and I would never buy the venue two plus thinking ecg is coming anytime soon, if at all. Number one, perhaps the hardware does not meet the requirements that they desired or that the clinical trial is evaluating.

Alternative number two It's possible that garment will not pursue FDA certification of this particular iteration of the hardware and software package, and even if they do, that doesn't mean they'll apply for certification with other regulatory bodies outside of the US, such as in Europe or other countries. If we look at Apple, they began with regulatory clearance in the United States and then expanded to Europe and other countries.

However, there are still countries today that do not have the ecg app available on your Apple Watch because they do not yet have regulatory approval in those countries, and in some cases, Apple simply hasn't applied for approval in those countries because the user numbers, whatever the case may be, do not justify it. 

Nonetheless, it is very clear that Garmin watch is working on this, obviously they have the clinical trial, they have the hardware. It's only a matter of time before they submit for FDA approval, receive that approval, and start seeing it in Garmin devices, but I wouldn't buy this watch for ecg functionality today.