A real-time, non-face-to-face biometric signal monitoring system for patients with an infectious disease has obtained regulatory approval as a medical device.
The government supported the development of the device to control and prevent Covid-19 infections.
The Ministry of Science and ICT said Tuesday that the biometric signal monitoring system won the nod. The ministry worked with the Ministry of Health and Welfare and the Ministry of Food and Drug Safety for device development.
The Electronics and Telecommunications Research Institute (ETRI), a state research institute, and a midsize medical device company jointly developed the monitoring system. The device consists of a biometric signal measuring device (VDR-1000) and a patient monitoring device (VMA-1000).
VDR-1000 measures the patient's electrocardiogram (ECG), pulse wave, pulse, respiration, and blood pressure. It then sends the measured values to VMA-1000, allowing medical professionals to monitor the patient's condition in real-time.
The real-time delivery of biometric signals of a hospitalized patient with infectious disease to physicians can minimize secondary infections among medical workers. The system also helps the hospital run workforce efficiently.
The science and ICT ministry said its close work with Daegu Gyeongbuk Medical Innovation Foundation (DGMIF), a medical device testing body designated by the food and drug safety ministry, shortened the testing and approval period from six to two and a half months.
The latest approval allows the local use of the device and even exports.
As the health authorities continue to concern for a second wave of the Covid-19 outbreak, installing the device in hospitals will help minimize the risk of medical professionals’ infections, the government said.
The system developer, Tribell Lab, said the demand for a biometric signal monitoring system was soaring.
“Many local hospitals, including the Seoul National University Hospital, SMG-SNU Boramae Medical Center, and the National Cancer Center showed interest in purchasing the device,” the company said.
The company is also in talks with WAA Group Inc. to export the system to Kuwait, it added.
The science and ICT ministry said it would actively help the company search for sales channels.
The company is seeking to win CE certification in Europe and FDA approval in the U.S. through the “regulation-free special zone innovation project” of the Ministry of SMEs and Startups.
When the company license in the technology from the ETRI in October, it will register it as an excellent procurement product with the Public Procurement Service.