South Korea’s Ministry of Food and Drug Safety (MFDS) recently approved two digital devices that aid in respiratory rehabilitation and the treatment of visual impairment due to cognitive diseases.
EasyBreath by Share & Service is a mobile application that provides an eight-week respiratory rehabilitation program for people with chronic obstructive pulmonary disease, asthma and lung cancer. Its goal is to reduce shortness of breath while helping to improve the user’s aerobic capacity.
VIVID Brain, developed by Nunaps, is a virtual reality-based software that provides 12-week visual perception training to improve a patient user’s brain elasticity and expand their visual field.
THE BIGGEST TREND
Its regulatory approvals had been accelerated after obtaining designated as innovative medical devices by the Korean government.
They are the third and fourth digital therapeutic device approved for sale in South Korea. In February of last year, the MFDS approved the Aimmed project Somzz, a DTx for insomnia. Regulatory clearance for WELT-I by Welt Co., another insomnia DTx, came two months later.