Samsung Electronics has won approval for its mobile application to measure blood pressure, a first in Korea as SaMD (software as a medical device).
According to the Ministry of Food and Drug Safety, the blood pressure app can use a smartwatch to check the user’s blood pressure, the systolic and diastolic blood pressure, and a pulse rate.
When the blood pressure app in the smartwatch measures the change in blood volume according to the heart rate using photoplethysmogram (PPG), the blood pressure value measured on the smartwatch is transmitted to the smartphone through Bluetooth.
The user can learn his or her blood pressure changes by checking the blood pressure value measured in the smartwatch or smartphone app and the information previously stored.
“This blood pressure app satisfied both the blood pressure and pulse rate accuracy standards, which are the performance standards for conventional automatic electronic blood pressure monitors,” the ministry said.
In February, the ministry reflected the industry’s opinion and revised rules to allow companies to win approval for a mobile app only, without any license on devices used for mobile platforms such as smartphones and tablet PCs.
“In the Fourth Industrial Revolution era, the development of mobile platform-based software medical devices is expected to accelerate,” the ministry said. “We will continue to support industries so that advanced technology-based medical devices can be commercialized quickly.”
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