Samsung Watches USA

[userZRSCLYzCJC]

As Samsung customers living in the United States, we are very disappointed that the Samsung Watch 8 and other Samsung Watches still do not have the Samsung Blood Pressure Monitor app enabled here. Could someone explain why this app is enabled for customers in Canada and other regions but disabled here in the US.

This Samsung Watch feature has been available in Canada and many other regions for some time. People in these regions have told us that the Samsung Blood Pressure app is a very useful tool in the Samsung Health/Monitoring ecosystem.

Further, these people say that while they understand that, like the Samsung ECG and other Health Monitoring apps, the Blood Pressure app may not be a standard medical device. However, they note that results obtained using the Watch Monitoring app are very close to the readings on standard Blood Pressure measuring machines. Therefore, if the Blood Pressure Monitor app were enabled on the Samsung Watches in the US, it would add value to the Watch by providing a useful, portable enhancement to the Samsung Health/Monitoring ecosystem.

Frankly, based on the positive reports from regions where the Blood Pressure Monitor app is enabled, we can not understand why Samsung can not enable the app here in the United States.

If it is because of possible legal reasons, Samsung could require people to sign a liability waiver in order to have the Blood Pressure feature enabled. If it is a governmental issue, why, after all this time can’t it be resolved?

In summation, we customers in the United States would like to have the Blood Pressure Monitor app enabled on our Samsung Watches, just as it is for customers in other regions.

Respectfully

[ducsurfer]

Dante is workingon it but with the new UI8 release it no longer works... ALL that are interedted follow WHOOP, they just received a CEASE&DESIST from the FDA... they are on the forefront fighting the FDA since they believe it requires "medical device" approval where as WHOOP claims they believe it is part of a "wellness" device...

[Ric221]

Dante63's workaround is currently down if you are running ui8 on your watch. From what I have read, he is working on a solution to address it.

[VerbumVeritum]

I'm confident he will have it working very soon!

[userZRSCLYzCJC]

May I thank everyone for the replies. I would like to mention the following -

1 - I am 82 with various age-related problems. I paid to have the Blood Pressure Monitor app "side-load" (I have few technical abilities) on my Watch 6.  This app allows me to easily check my Blood Pressure. Comparing Watch 8 reading to those taken by my Doctor, the app is spot on. Therefore, I think the app should be made available to everyone. 

2 - When I tried to transfer the app along with the other data from my Watch 7 to a Watch 8, the Blood Pressure Monitor was the only thing that did not transfer. I returned the Watch 8. 

3 - I have sent emails to various people in the FDA and HHS offices asking them to expedite the approval process for the Blood Pressure Monitor app.

4  - I wonder if Samsung could not take the initiative. Perhaps renaming the app in the US as "Blood Pressure Indicator app" with an admonishment to users - that the app has not been officially approved by the FDA and should be used accordingly.

5 - As the Watch 8 has improved sensors, it would be great to have at ability to be able to take your Blood Pressure using the Watch 8.

Pending getting the FDA approval or Samsung's initiation, I look forward to a workaround that will allow the Blood Pressure checking on Samsung Watch 8.

Again - Thank you.

[userZRSCLYzCJC]

TYPO CORRECTIONS  (sorry I'm old)

May I thank everyone for the replies. I would like to mention the following -

1 - I am 82 with various age-related problems. I paid to have the Blood Pressure Monitor app "side-load" (I have few technical abilities) on my Watch 7.  This app allows me to easily check my Blood Pressure. Comparing the Watch 7 reading to those taken by my Doctor, the app is spot on. Therefore, I think the app should be made available to everyone. 

2 - When I tried to transfer the app along with the other data from my Watch 7 to a Watch 8, the Blood Pressure Monitor was the only thing that did not transfer. I returned the Watch 8. 

3 - I have sent emails to various people in the FDA and HHS offices asking them to expedite the approval process for the Blood Pressure Monitor app.

4  - I wonder if Samsung could not take the initiative. Perhaps renaming the app in the US as "Blood Pressure Indicator app" with an admonishment to users - that the app has not been officially approved by the FDA and should be used accordingly.

5 - As the Watch 8 has improved sensors, it would be great to have at ability to be able to take your Blood Pressure using the Watch 8.

Pending getting the FDA approval or a Samsung's initiative, I look forward to a workaround that will allow the Blood Pressure checking on the Samsung Watch 8.

Again, thank you.

[pool_shark]

Under the current administration I doubt that the FDA even cares anymore.

However, even if the FDA does care, Samsung should be able to state that the BP monitor function is for entertainment purposes only and is in no way meant to be used to diagnose or treat hypertension.

[userZRSCLYzCJC]

As I noted previously, I had the Samsung Blood Pressure Monitor app sideloaded on my US phone and Watch. The app does its job well. Friends in Canada, where the app is officially enabled  also confirmed the app works. Why the FDA has delayed approval of this app is unknown. 

I, too, believe Samsung should take the initiative and enable the app. Call it whatever it needs to and make it available in the US. If necessary add a disclaimer on the use of the Blood Pressure app. Samsung already uses a disclaimer on the ECG app. 

Hopefully, the smart people on this forum will find a work around if Samsung, itself, does not enable this app.

Speaking for myself, I would like to upgrade my S24 phone and Watch 7. But I won't because doing so would result in losing the Blood Pressure app. In fact I returned the Watch 8 because I could not get this app enabled.

[userZRSCLYzCJC]

As customers, all we are asking to get the Blood Pressure Monitor enabled by Samsung as they have done for customers in Canada and other regions.
Whatever the reason, Samsung should be able to resolve it as it has for other regions. Samsung announced the Blood Pressure Monitor for their Watches more than 3 years ago.
Samsung is a giant company that certainly has the assets (cash & people) to get it done.

Likely, the FDA is the problem. Regardless, the US is a large market and Samsung should service the US customers accordingly.

[ducsurfer]

The answer is with the FDA... follow the recent "cease and desist" letter sent to WHOOP... it tells alot, essentially the FDA considers BPM as a "medical" device hence they "must" regulate where as WHOOP argues its a "wellness" device. The control is getting silly, given SHM MOD's 30 day calibration, this simply becomes a NONE issue?

[userZRSCLYzCJC]

I agree with everyone, there is no doubt that the federal FDA is the problem.

But I find it hard to believe that after 3+ years, a company with the assets of Samsung could not either

a) Get whatever issues the FDA has with the app resolved,   or

b) Get the App reclassified from a medical device to a non-medical device, such as WHOOP, if necessary by a court. I would bet Samsung has the legal talent available to get it done.

As acknowledged previously, the FDA is the problem. But it does feel that Samsung could be more proactive in its efforts to get the BP feature enabled in the US.

Just my opinion.