Garmin ECG Notification (Pre-Market, FDA)

Pre-market FDA Listing for Garmin ECG

Garmin ECG Notification

Garmin really is close to market with an ECG-enabled product as the above image clearly shows.

Here is the story so far.

  1. In March 2022 dcraimaker reported he found a since-removed ECG diagnostic screen in his Garmin Venu 2 (a watch released in June 2021)
  2. Garmin works on ECG validation studies – More: here and here (2021).
  3. Garmin gets ECG Patent approval – More: here
  4. Garmin leak shows new ECG-related functional is already in Garmin Connect – More: here
  5. Garmin files for FDA approval and is given a pre-market listing (above)
Image: dcrainmaker, https://www.dcrainmaker.com/2022/03/garmin-watch-ecg-feature-demonstration-clinical-trials-venu2-plus.html

ECG is predominantly a wellness feature rather than a fitness or athletic feature.

Q: Which watches will get ECG?

Firstly the hardware must support ECG. I’m sure that several existing models already have the required hardware and that even some recent Garmin watches do NOT have the required hardware. Garmin also has to specifically release ECG support for the watch(es) in question.

It’s reasonably likely that going forward, ECG support will be given to many Garmin watches so we will probably see the following kind of rollout over the months ahead.

  • Stage 1 – New feature launch on a new watch – I’m betting on the Vivomove Trend (an outside bet) only because that watch is also going to be Garmin’s first QI-capable watch.
  • Stage 2 – Rollout to existing watches with the necessary hardware already in place – I’d be extremely surprised if the Fenix 7 fails to get this. I would NOT be surprised if the Fenix 6 fails to get ECG.
  • Stage 3 – Release on most new Garmin watches that are non-plastic/non-athletic watches eg the upcoming Forerunner 265 probably won’t get it.

 

 

Garmin gets ECG Patent – showing how it works and indicates which current models get ECG

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11 thoughts on “Garmin ECG Notification (Pre-Market, FDA)

    1. Not really… just a lot of spam on /r/medical and other subs/forums with random 1-lead ECG results asking “is it okay?”

  1. But it can be implemented in Europe only with the FDA approval? I thought not.
    We have seen for example that the Index BPM is not yet sold in Europe.

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