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09-12-2020
11:29 AM
1 Like
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.
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09-12-2020
11:22 AM
1 Like
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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09-11-2020
09:27 PM
2 Likes
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.
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03-25-2020
05:48 PM
2 Likes
Regardless of FDA approval at this point, they marketed the watch with forthcoming ECG and fall detection as it's main selling point. No updates, not info, more than six months now and the only change is they've quietly removed all info about the features from all literature on the site and from all vendors selling the watch. I'm giving it all a pass right now cause we have bigger issues and more important things all of us need to focus on... But it's still a let down and when things settle there should be a meaningful response to what's going on.
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03-25-2020
05:43 PM
1 Like
It's all a pipe dream at this point with the GWA2. Especially with everything going on right now...
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03-08-2020
08:37 PM
3 Likes
Agreed, I'm pretty sure we've all read the handful of "scources" that are old, not verified and do not provide any reference to their claims. The most disheartening, I'm sure for all of us, is the complete lack of anything from Samsung, other than quietly removing all mention of it from their site and for all vendor sites, which is worrying. Pretend you're a first time buyer and you know very little about the watch, and go "shopping" for it now... You'd buy the watch not knowing that ECG and fall detection are forth coming features, that the watch has the hardware, or that Samsung is waiting on FDA approval. I'm still trying to be patient, but it's beginning to wear thin, and I have little to no positive speculation as to why...
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Re: None
03-06-2020
09:45 PM
Do you want the arrow too?? cause that might hurt. Or did you mean :ribbon: cause you can have this one.
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03-06-2020
09:33 PM
It's not something y'all should expect anytime soon, if ever. It's quite a challenge to have a wearable that can generate a strong enough magnetic field, efficiently and with enough fidelity to conduct secure payments required by regulations. Not to mention taking into account users constantly touching the watch bezel and screens to POS machines and the accellerated wear and tear, and high damage rates that would certainly result. I would love for the watches to have MST, but at least they provided NFC. The day a wearables can provide wireless charging will be the day MST becomes feasible, but still likely not possible.
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03-05-2020
03:32 PM
1 Like
There are some options available, but if you're looking for approved ECG wearables the options are very limited. Apple is the only fully featured watch on the market that does. Others make sacrifices in utility as they are more health or fitness focused rather than including productivity, app and UX options since they are not phone manufacturers as well. Think Garmin, FitBit etc who rely on API rather than source code for interoperability with phones. You can try to import Chinese wearables with ECG, but they are not approved or sold in the US if that's your region.
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02-28-2020
07:48 PM
1 Like
That was just someone ruffling feathers. News without credible, or any reference really is just trolling. We're all forced to be patient in the dark. It's a good watch even without it, it's just disappointing that Samsung won't engage with its customers about the main feature most of us bought it for, over cheaper and basically equivalent options. : /
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