The Ministry of Food and Drug Safety (MFDS) has approved the world's first blood pressure measurement app "Samsung Health Monitor" developed by Samsung Electronics.
The device is a medical device that measures blood pressure using a mobile app. It is equipped with software that conveniently measures blood pressure using a smartwatch on the wrist and informs users of the contraction of the heart, diastolic pressure and pulse rate, the MFDS said on April 22.
The app met all the medical device performance standards that the automatic electronic blood pressure system should meet. For an automatic electronic blood pressure system to be licensed as a medical device, the blood pressure accuracy should be below ±5 mmHg on average and the pulse rate below ±5 %.
The health monitor is scheduled to be released within the third quarter and will be available for new smartwatches, including the Galaxy Watch Active2.
In Korea, where telemedicine is not permitted, blood pressure and ECG measurements using smartwatches have been regarded as remote medical activities due to ambiguous related guidelines and regulations, even though they are not directly related to medical practices.
However, the MFDS has improved the regulations, paving the way for telemedicine. The MFDS said it will support the rapid commercialization of medical devices that incorporate high-tech technologies in the wake of the fourth industrial revolution.
Samsung Electronics is also expected to strengthen its smart health sector with the approval. Since 2017, Samsung Electronics has been providing exercise and health care services by installing the "Samsung Health App" on its Galaxy smartphones.
