'Beyond Disease to Disability' Domestic 3rd and 4th DTx Approved... Visual Impairment Improvement and Respiratory Rehabilitation

The Ministry of Food and Drug Safety announced on April 19 that it has approved two digital therapeutics (DTx) devices as the third and fourth domestic approvals: Vivid Brain, a cognitive therapy software by NewNaps, and EasyBreathe, a respiratory rehabilitation software by Share & Service.

Share&Service's respiratory rehabilitation digital therapeutic device (DTx) 'EasyBreathe'
[Photo by Share&Service]

These two products are software as a medical device (SaMD) implemented as mobile applications. Vivid Brain improves the narrowed visual field of patients with visual impairments caused by brain diseases. It provides visual perceptual learning training aimed at recovering visual perceptual function through repetitive training with visual stimuli over 12 weeks. EasyBreathe improves aerobic exercise capacity and symptoms of dyspnea in patients with chronic obstructive pulmonary disease (COPD), asthma, lung cancer, and others. Based on a 6-minute walk test, it offers customized respiratory rehabilitation training focused on aerobic exercise such as walking for 8 weeks.

The Ministry of Food and Drug Safety closely supported the development and clinical trial design of both products and approved them after scientific and thorough review. Recognizing their innovativeness and clinical efficacy, both products were designated as innovative medical devices earlier this year and are being supported to be rapidly used in actual medical settings through the ‘Integrated Review and Evaluation System.’

Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, stated, “This approval demonstrates that DTx can be used not only for disease treatment but also for alleviating disabilities,” and added, “We expect that DTx will help improve the quality of life for patients struggling with diseases or disabilities.”