Omron’s HeartGuide Blood Pressure Watch Gets FDA Clearance, Will Launch in January

Omron HeartGuide FDA

The Omron HeartGuide, a blood pressure monitoring smartwatch has received FDA clearance. The HeartGuide is essentially a blood pressure machine that works just like a full-size machine — a sphygmomanometer.

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New blood pressure guidelines issued this year suggest 46% of Americans have high blood pressure, up from 32% under the decades-old standard. High blood increases your risk of stroke, heart attack, heart failure, sudden cardiac death, kidney failure and damage to your eyes. If your checkup shows that you have normal blood pressure, you shouldn’t be too confident because major studies have shown that 10% of us have masked hypertension, which doesn’t show up at all during a physical. These can be only discovered after constant monitoring.

This year at CES 2018 Omron Healthcare demonstrated HeartGuide, the company’s smartwatch built around an oscillometric (inflating) blood pressure monitor. The company is also famous for making electronic cuff-style blood pressure measuring devices that are used by doctors and hospitals. Omron is also a major seller in consumer electronic blood pressure devices, with various upper arm and wrist cuff devices. So now Omron is coming out with its own wearable using the gold standard technology, only smaller, reported Healthtech Insider.

Omron HeartGuide FDA

“Imagine a world without heart attacks or strokes. No, it’s not a dream. It’s our goal. Zero heart attacks. Zero strokes. That’s Generation Zero. It’s a generation not defined by its age but by its desire to live healthier and longer. It’s a new way forward,” says Omron.

According to Omron, the smartwatch will do anywhere between 30 and 50 inflations, and should need charging once or twice a week. About all the data generated by the watch, Omron says it wants to make people aware of what they mean.

“Too many times today 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,” said Jeff Ray, Omron’s executive director of business and tech.

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Omron starts taking pre-orders today and will start shipping on January 8. The watch comes in 3 sizes. In addition to tracking blood pressure, the watch provides real-time information on physical activity and sleep. The Omron HeartGuide retails for $499.

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Cathy Russey
Cathy Russey () is Online Editor at WT | Wearable Technologies and specialized in writing about the latest medical wearables and enabling technologies on the market. Cathy can be contacted at info(at)