Blood pressure monitoring

[spectrum19007]

How much longer arecwe going to have to wait for Samsung to do what it needs to have the watch approved to measure blood pressure by the FDA?

[bill-e]

No one knows and no one is telling 😉 

[Sarge2]

At this point I almost doubt it will ever happen to watches sold in the US at least in my lifetime (And I am not that ild)
Starting to think it was just a false selling point.

[spectrum19007]

I think it will take a concerted effort from smart watch users to get the same features that we paid for as those in Europe, South America, and Canada. 🫤

[userpMgFwKaOxb]

The Omron device uses a highly engineered method based on standard air-bladder blood pressure devices. In contrast, Samsung uses PPG optical sensors and software to estimate/measure BP. Other companies that use PPG sensors and software have received FDA approval, and I think it is a matter of time, but more so, of will for Samsung to get approval. I suspect that the reason Samsung has not received certification of their BP feature in the US is in the software, somewhere. Remember, PPG is an indirect and inferential method of measuring BP. It relies heavily on the precision of the sensors as well as that of the software. Knowing Samsung, the hardware is a lock. I'm not so sure about the software. I think that is where the holdup exists.

[Rayzer]

Blood pressure monitoring on smart watches use a technology called photoplethysmography, or PPG. This technology is currently not very accurate. Huawei is introducing a smartwatch this fall that will actually have an inflatable cuff on the band. Even dedicated blood pressure cuffs on your wrist are not as accurate as the ones that go on your bicep. If you want accurate measurements, your best alternative at this point is to get a dedicated blood pressure monitor.

[spectrum19007]

That is how heart rate is measured. And it is partly how blood pressure is determined by the watch. Pulsewave analysis performed. Studies have shown that this is actually accurate and reliable. Which is why 25+ countries allow it including Germany, France, and Canada.

[Robin621k]

The Food and Drug Administration (FDA) is likely to never approve blood pressure monitoring. The financial investment in device manufacturers is significant, amounting to a billion-dollar industry.

When Samsung hosts its keynote events, it should be noted that they are a global company. Their keynotes cater to the global community, not just the United States. Each country has its own regulatory body which approves or disapproves medical devices. It would be wiser for you to address your concerns with the FDA, not with Samsung.

[CharlieTierrax]

The FDA won't approve any "medical device such as this" to be used in the USA, unless it passes all FDA requirements, period. The Agency is clear on "testing for its intended use", meaniing until the device passed ALL FDA requirements without any major issues, it will be a no-go.

[RedOregon]

That is a government issue, not a manufacturer issue. Contact your local political representative.