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ECG update with FDA links

(Topic created on: 9/12/20 11:29 AM)
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Galaxy Watch

I've been meaning to post this for a while. Having extra time on my hands starting around March, I began a deep research dive into the FDA to understand the hang up with ECG and other features long missing. This post serves as an info dump, for anyone that's curious. This is several months of research analysing databases, FOIA requests and others. I will do my best to parse useful info, add relevent links and provide my best non-professional interpretation where needed. Let me know if you have questions and I can help. 

 

The issue has been the lack of FDA clearance for a year now, and the lack of response by Samsung and moderators on here, and the industry as a whole. We've all been left in the dark for a year now and its sucked. While searching, I was unable to find any approvals for Samsung wearables. I had sought out via FOIA any filed applications, but I never found any. Here's what I have learned. 

The hardware for the ECG function is made by a third party called VectraCor Inc. located in New Jersey. Their hardware was FDA approved in August 2018 and is the same hardware found in Apple watches. Their 510(k) number is K173952 and their filing can be found here -

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173952

 

For our watches, and Apples, the approval needed isn't for the hardware, but rather the software and app we interact with and displays the information. This is known as, Electrocardiograph Software for Over the Counter Use. Under regulation 870.2345 and Product Code QDA as a Class 2 Device. Both Samsung and Apple only need to demonstrate that the apps are, and operate Substantially Equivalent to other similar products, also known shorthand as SESE. This is a 90 day process from application to approval. For reference, you can see Apples approval filed under their 513(f)(2)(De Novo) number DEN180044 here -https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN180044

 

There's a lot more to share, but the last bit worth mentioning is the recent FDA approval for Samsung. Under the same 870.2345 regulation for QDA Class 2 Device filing, Samsung's ECG app was submitted June 1, 2020 and approved on August 4, 2020. It can be found under their 510(k) number K201168 here -

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201168

 

Again, this represents a fraction of the information I've gathered, but I wanted to share it with all of you for your own interpretation or research purposes. It's good news, and means a near future update will likely include the ECG function, and others we've all be waiting for. What I haven't been able to uncover, at least with any clarity or certainty, is why it took almost a year to submit the application. This is likely an internal Samsung thing, so we'll likely never find out. Either way, hope y'all enjoy the functions when the get released soon, they will be coming as an app update and likely here very soon before the end of the year. 

7 Replies
userk2TGTD8zAf
Asteroid
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Galaxy Watch

Thank you for the info. I hope that this is true. I always thought that this might be an internal thing at Samsung. We can say that they released the watch waaaay to soon, just to have something against the apple watch while actually lying about the ECG. Thats a bold move for such a big company.. 

Solution
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I shared FDA sources to make sure it's credible and can be verified by anyone. There's a lot of possible reasons for why Samsung handled this they way they did, but it would have to come from them as they're the only ones that know. 

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oeagleo
Nebula
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Galaxy Watch

Echoing the previous responder, I too, appreciate the work you've put into this.  This (to me) leaves one very blaring question.

Given that the Active 2 release date was September 23, 2019, and the Active 2 was advertised as having the ECG (and fall detection, no federal blessing is needed for this I don't think), why did it take Samsung until June 1, 2020 to even SUBMIT the request???  They KNEW they hadn't even asked for the approval until almost a year later, and only 2 months before the release of the new model (Watch 3)???  

Seems that there's something missing here, especially after late in the model year, they (Samsung) removed the reference to the ECG function in their advertising on the website.

Just pondering the apparent abnormalities here, but between this, and the "Yes, the watch is waterproof up to 50 meters, but you took a shower with the watch, so your warranty is now void" syndrome I see here, I'm just about ready to go back to Apple.

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After all my research and close monitoring of Samsung, the only thing I can say with certainty is they missed an opportunity. A little more transparency would have paid divide meds in customer satisfaction and loyalty. Instead, and I think is rings true for most of us, is we've been left with a bad taste in our mouths and it's a shame. The more I uncovered the more questions it raised. Sadly I'm at a point where I cannot go much further and Samsung themselves would need to chime in. There's a lot of armchair theory that can keep going for sure though. Maybe Samsung had legitimate reasons, maybe they didn't, and we may never know. 

Tomel
Cosmic Ray
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Galaxy Watch

Great work. Thanks. In another thread, somebody said this approval of the ECG software was for Samsung phones only. Unless I'm missing it, I don't see where approval of the software was limited to any specific phone or manufacutrer. Therefore, Samsung should make the ECG monitoring software available for other android phones -- just like it does for it's other software (or should have disclosed in their advertising that you had to have a Samsung phone to use that feature).

 

TimJK
Astronaut
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Galaxy Watch

Agreed - I don't see how the phone has anything to do with the App

userVVRmmnrwpC
Astronaut
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"Don't see how the phone has anything to do with the App" - In my case Samsung Support told me that my Note5 was for use in Spain and therefore the ECG won't work with the Watch3 because "Samsung Health Monitor is not available in your current location" shows on my phone. 

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