​Samsung gets blood pressure approval – and it's coming to new smartwatches

It's coming to Active 2 and new devices
Samsung new feature gets medical approval
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Samsung has got approval for its blood pressure monitoring sensor, and will start offering the feature as early as Q3 2020.

The sensor has been present on the Samsung Galaxy Watch Active 2 since launch, and beta trials have taken place in select countries, with an app developed in partnership with the University of California San Francisco.

However, without medical approval, Samsung had to temper expectations that blood pressure monitoring was to be relied upon, by warning it was “not intended as a medical device or for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.”

That’s changed with regulatory approval from the South Korean Ministry of Food and Drug Safety (MFDS), as a Software as a Medical Device (SaMD). However, it looks like only wearable devices make the grade, as there's no mention of the Samsung Galaxy S9 smartphone.


The company has confirmed that the feature will land on the Samsung Galaxy Watch Active 2 in Q3 “and will progressively expand to upcoming Galaxy Watch devices.” We’re expecting a Samsung Galaxy Watch Active 3 soon, and that could even include the Galaxy Watch 2.

Read more: Upcoming smartwatches 2020

However, that doesn’t mean we’ll automatically see the feature available in the US or Europe quite yet – as it will likely need to be approved by relevant regulatory bodies including the FDA.

But there are some quite large caveats in the approval, which make it a little short of ideal for the general consumer.

For the blood pressure monitoring to work it needs to be validated against a traditional cuff, and re-validated every four weeks. It’s not clear how this validation process would work.

For those that need to check blood pressure every day, that’s easily worth the hassle. But for the general population without access to a cuff at home, it's not the holy grail of blood pressure awareness.

Blood pressure monitoring is something that consumer wearables haven’t yet cracked, so it’s certainly a boon for Samsung to lead in this area. But it also shows how difficult it is to get regulatory approval. But to a lot of people who suffer with high blood pressure, it’s certainly a step forward.

And as Samsung wrote in its online reveal, it's an area worth investing in.

“Globally, high blood pressure is known to significantly increase your risk of brain, kidney and heart diseases, including stroke and coronary heart disease when not managed properly. By helping users measure and track their blood pressure, the Samsung Health Monitor app gives people greater insight into their health and allows them to make more informed decisions, to lead healthier lives.”

Watch this space for availability, and of course, new Samsung devices as they land.