The South Korean Ministry of Food and Drug Safety (MFDS) has recently approved two digital devices that assist in respiratory rehabilitation and treatment of vision impairment due to cognitive illnesses.
EasyBreath by Share & Service is a mobile application that provides an eight-week respiratory rehabilitation programme for persons with chronic obstructive pulmonary disease, asthma, and lung cancer. It aims to reduce breathlessness while helping improve a user’s aerobic capacity.
VIVID Brain, developed by Nunaps, is a virtual reality-based software that provides a 12-week visual perception training to enhance the brain elasticity of a patient user and expand their visual field.
THE LARGER TREND
Their regulatory approvals had been expedited after getting designated as innovative medical devices by the Korean government.
They are the third and fourth digital therapeutic devices to be approved for sale in South Korea. In February last year, the MFDS approved Aimmed’s Somzz, a DTx for insomnia. The regulatory clearance for WELT-I by Welt Co., another insomnia DTx, came two months later.