Omron's smartwatch blood pressure monitor cleared by FDA, launches in January

The HeartGuide watch uses a flexible synthetic band to inflate and maintain its shape to comfortably take an oscillometric wrist blood pressure on the fly.
By Dave Muoio
11:48 am
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This morning, Omron Healthcare announced that the HeartGuide wristwatch — a wearable oscillometric wrist blood pressure monitor unveiled earlier this year at CES 2018 — has received FDA clearance and will be available at retail on January 9, 2019. The device is currently available for preorder for $499.

The key feature of the product is a flexible synthetic band that is designed to inflate and maintain its shape when taking a blood pressure reading, yet remain comfortable on the wrist. According to the company, more than 80 patents were filed directly relating to band and other components required when designing the new device.

Alongside the blood pressure feature, which can also be programmed to take a reading during the night, the HeartGuide tracks other metrics of health including daily steps and sleep quality. Also to be released in January is a free-to-download companion mobile app that will look to better educate wearers on their health readings while offering personalized recommendations for improving their health.

Why it matters

Heart conditions are extremely prevalent, with more than 40 million people in the US whose blood pressure is uncontrolled, according to the CDC. As the first wrist-worn personal device for blood pressure monitoring, the HeartGuide would be a substantial boon for heart data collection and management among consumers, Eric Topol, founder and director of the Scripps Translational Science Institute, told MobiHealthNews when the device was first unveiled.

“I think when you have blood pressure on your wrist, even though it’s intermittent … it will get a lot more sampling then if you have to pull out a cuff and put it on your arm or your wrist,” he said. “Blood pressure is the number one chronic condition, and we don’t have arms around it in terms of management. Half the people poorly manage their blood pressure.”

What’s the trend

Omron has a few heart monitoring devices in their pipeline, such as a blood pressure monitor and ECG combo device intended for use in the home. This product comes as a result of the company’s ongoing collaborations with mobile ECG company AliveCor, in which Omron is a major backer.

Of course, the HeartGuide’s upcoming release also heats up the budding market for wrist-worn heart health monitoring — it's only been a few weeks since the Apple Watch’s ECG feature went live.

On the record

"Since Omron first announced this device, we have received countless messages from consumers expressing interest,” Ranndy Kellogg, CEO and president of Omron, said in a statement. “As a medical-grade blood pressure device in the form of a wrist watch, HeartGuide is a breakthrough for the category and for those who want to keep a close watch on their blood pressure anytime, anywhere."

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