It is believed that the epic will be released soon with ECG feature. Can anyone confirm this?
It is believed that the epic will be released soon with ECG feature. Can anyone confirm this?
The Garmin ECG app is FDA approved.
Here’s the information from the FDA website: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221774
From DCR’s article: “This entire process…
If you did enough research you would find that the only thing that is FDA Approved is the ECG App itself. Not the watch, not any other sensors or anything else. Just the ECG App, that can later on Garmin…
No. Its missing the needed hardware for ECG.
yes, but I heard rumours that it will be added to the new model
No one here can confirm that, obviously. We don't know and Garmin won't tell.
There probably will be a Plus version of current Epix that has the ECG sensor. It's safe to say that all top tier watches from Garmin will offer ECG, since they did invest a lot of money in FDA approval,...
Yes, probably in the next to weeks.
Every >$200 non-garmin smart watch for past few years has had ECG so this alone is not worthy of an Epix+. Now if they would add LTE and ECG and make it waterproof for casual scuba, that would close most of the feature deficit with $200 cheaper Apple Ultra.
they did invest a lot of money in FDA approval,
FDA Consent. Very different from FDA Approval.
No, it’s approved.
www.dcrainmaker.com/.../amp
No. Garmin have received FDA Clearance. DCR is also wrong. Go look up the difference between FDA Clearance and FDA Approval for devices.
The Garmin ECG app is FDA approved.
Here’s the information from the FDA website: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221774
From DCR’s article: “This entire process, from an official clinical trials standpoint, started all the way back in April 2021 (nearly two years ago). Of course, that’s just when they submitted their first formal paperwork that’s public, not when the engineering and preparations started. All of this concluded about 10 days ago when Garmin received their final FDA approval”
philipshambrook, do you have any reliable source that shows the ECG app is “FDA cleared“ and not “FDA approved”?
Lastly, this is really splitting hairs, here. No one is using the ECG app in a surgical procedure. It’s used to detect normal sinus rhythm and aFib on demand, and users can use these data points as part of a discussion with their doctors. If a doctor does suspect something based on the Garmin ECG information, they will conduct testing with far more accurate and advanced equipment.