S. Korea approves 'world's first' medical device for blood pressure app

By Lim Chang-won Posted : April 21, 2020, 10:05 Updated : April 21, 2020, 12:37

[Courtesy of Samsung]


SEOUL -- South Korea's state public health watchdog has approved the world's first medical device to measure blood pressure using a mobile app, which was developed by Samsung Electronics. The watchdog pledged support for quick commercialization.

It is "the world's first medical device for a blood pressure app," the Ministry of Food and Drug Safety said in a statement. "The blood pressure app met all the performance criteria of the conventional automatic blood pressure system, which is commonly used."

The software conveniently measures blood pressure using a smartwatch on the wrist and informs users of blood pressure and pulse rate without wearing the cuff, a device that provides blood pressure readings, on the arm, the ministry said.

Samsung said in a statement that its cuffless blood pressure monitoring app will be available within the third quarter of this year. The device measures blood pressure through pulse wave analysis, which is tracked with heart rate monitoring sensors, Samsung said, adding users can simply tap to measure their blood pressure by calibrating Galaxy Watch Active 2.

"This is one of many examples of how Samsung is integrating its best-in-class hardware with the latest software innovations to innovate mobile experiences," Yang Tae-jong, head of the health team at Samsung's mobile communications business, was quoted as saying.

Samsung said that its Galaxy Watch Active 2 comes with more sensitive and accurate heart rate monitoring sensors and enables users to track their exercise, sleep, stress and get added healthcare insights.

By operating the blood pressure app on the smartwatch, it uses a photoplethysmogram (PPG) to measure blood volume changes, the ministry said. PPG is a recording made by a photoplethysmograph.

The value of blood pressure, measured by the smartwatch, is transferred to the smartphone via Bluetooth. Measured blood pressure values or stored information are compared to check the change in the user's blood pressure.

Smartwatches for estimating blood pressure in real time have been developed at home and abroad. The ministry vowed to support the rapid commercialization of medical devices that incorporate high-tech technologies in the era of the Fourth Industrial Revolution.

In March 2019, MEMO Watch, a wearable medical device designed to monitor and proactively manage a chronic cardiac disease, became the first to win temporary state approval under a government campaign to ease or suspend regulations for the development of information and communications technology.

 
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