Omron gets FDA clearance for HeartGuide, a blood pressure monitor for your wrist

The wearable blood pressure monitor becomes official
Omron's blood pressure watch is go
Wareable is reader-powered. If you click through using links on the site, we may earn an affiliate commission. Learn more

For almost two years Omron, maker of blood pressure monitors, has been working on a watch that’s able to take oscillometric blood pressure readings from the wrist. The company has just revealed that it’s secured FDA clearance for “Project Zero” – now officially named HeartGuide – and that the watch will be available in January.

The HeartGuide watch, which we first glimpsed at CES in January, uniquely hides a blood pressure cuff under the watch strap, which can inflate at set intervals through the day and night to take – so Omron claims – medically accurate readings.

Essential reading: Blood pressure is wearable tech's next big challenge

There’s a cornucopia of smart blood pressure monitors on the market, but nothing like this that also has the FDA stamp. That stamp was vital for Omron, meaning the watch graduates from being a monitor that can make estimates, to something a doctor could use to track your risk of hypertension.

“It took us a little longer than we hoped,” admits Omron president Ranndy Kellogg in a call with Wareable. Omron couldn’t simply rip the tech out of one of its existing monitors and wrap it around the wrist; the HeartGuide required a complete rethinking of how all the moving parts would work – the bladder, the cuff material (they couldn’t use leather; it stretches)…


"If you think about the physiology of someone’s arm, there’s a lot of things we had to consider – veins, tendons, bones, just the shape and size of people’s wrists. So we had to think about how to redesign this bladder that inflated,” says Jeff Ray, Omron's executive director of business and tech.

We’re going to make a lot of discoveries with this device

“The best analogy I can use is, if you blow up a balloon, you set it on a table and you push down on in and squish it. What happens? It goes sideways.”

Omron had to engineer a way for the bladder to instead inflate upwards, and it’s why most of the company’s patents (it now has 89 to its name, 30 from this year) concern the structure of the inner cuff.

Ranndy says they shrunk some of the internal components smaller than a grain of rice, allowing them to keep the watch as small and comfortable as possible. The idea is that users will keep this on when they’re in bed so it can take measurements through the night, and to avoid the risk of waking up with a swollen purple hand due to malfunction, Omron has even built in back-up components should one fail.

Uncharted territory

Omron gets FDA approval for HeartGuide, a blood pressure monitor you wear on your wrist

Omron's Project Zero 2.0 up close at CES in January

With Omron now able to put its HeartGuide on people’s wrists and keep it there day and night, people will be able to monitor their blood pressure in a way that's not been possible before – and who knows what this trove of data may reveal? “We’re going to make a lot of discoveries with this device because it is a wearable,” says Jeff.

On a single charge the watch will get anywhere between 30 and 50 inflations, according to Omron, and should need charging once or twice a week. It also means a lot of data for users to sift through, and Omron is keen to not just throw numbers at the screen but to contextualise them.

“To many people their blood pressure is nothing more than two numbers – 140 over 90 or whatever – there’s no meaning to it. We’re trying to give meaning to it,” says Jeff.

We’re trying to help people connect the dots but they have to be equal partners with us

If Omron wants to achieve its goal of helping eliminate heart attacks and strokes, these readings can’t just be data points. It plans to use its app to give feedback on trends and insights by getting users to share as much information about their lives and habits as possible, but this may prove tricky.

Sure, the watch tracks movement and sleep using an accelerometer, but Omron wants to be able to tell you that your blood pressure is higher on days you’re smoking more cigarettes, or when you’ve been arguing with your spouse – and to do that it needs a lot of input from users. “We’re going to need people to help us out,” says Jeff. “We’re trying to help people connect the dots but they have to be equal partners with us.”

Omron hopes, at least, one of the immediate impacts will be encouraging patients to stick with their medication. “When people skip their medication they don’t feel any different – but if you’re measuring you’ll be able to see a difference in the data”

Omron will start taking pre-orders 20 December and start shipping 8 January. The watch, which comes in three sizes (although only the medium will be available to start with, Omron confirmed), will cost $499. It’s steep for a “smartwatch” – it offers notifications as well as step tracking and other smartwatch table stakes – but this a specialist medical device.

And Omron is already considering what types of doors a wearable, medical-grade blood pressure monitor could start to open.“We can really start looking at the predictive world," says Jeff. "As we start looking at creating your own personal baseline of health – where someone needs to worry about is when they deviate from the baseline.

“The day may not come too far off when we can tell people days and weeks [before] that a heart attack or stroke is imminent.“

What do you think?
Reply to
Your comment

1 comment

  • NanaGail·

    I am one of those people whose BP makes many wide swings in the course of a day.I was recently hospitalized for a stroke due to extremely high blood pressure. I love that the product has FDA approval and is made by the company which I consider to be the premier maker of BP monitors and other medical equipment, however the cost is prohibitive. While I am considering purchasing one and would be very cooperative in letting the company know of my activities and emotional state and sleep experience, I do not know whether this device would be attainable given that my husband is only 8 months away from retirement.