MFDS Grants World's First Approval for 'Blood Pressure Measurement App'

[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety announced on the 21st that it has approved the world's first software medical device (SaMD) that measures blood pressure using a mobile app.

The SaMD is a 'Blood Pressure App' developed by Samsung Electronics. Instead of the traditional 'cuff' worn on the arm that inflates and deflates to measure systolic and diastolic blood pressure, it uses a smartwatch (mobile platform) worn on the wrist to conveniently measure blood pressure and informs the user of the heart's systolic and diastolic blood pressure as well as pulse rate.

The operating method involves activating the blood pressure app on the smartwatch to measure changes in blood volume according to heartbeats using photoplethysmography (PPG). Then, the blood pressure values measured on the smartwatch are checked and transmitted to a smartphone via Bluetooth. Finally, the user can check changes in their blood pressure by reviewing the measured blood pressure values or previously stored history information on either the smartwatch or smartphone app.

The Ministry of Food and Drug Safety explained, "It met all the accuracy standards for blood pressure and pulse rate, which are the performance criteria for existing automatic electronic blood pressure monitors as medical devices."

Earlier in January, the Ministry held a meeting with mobile app companies to promote the development of cutting-edge software medical device products, listening to domestic and international product development trends and regulatory improvement needs.

Subsequently, in February, reflecting industry opinions, the guidelines for the safety management of mobile medical apps were revised to allow mobile apps alone to be approved without requiring approval for devices or equipment used as mobile platforms such as smartphones and tablet PCs. A total of 35 mobile app medical devices, including medical imaging analysis software, have been approved.

The Ministry stated, "With the advent of the 4th industrial era, we expect the development of software medical devices based on mobile platforms to become more active," and added, "We will continue to support the rapid commercialization of medical devices incorporating advanced technology."

This content was produced with the assistance of AI translation services.