[메디칼업저버 손형민 기자] Insomnia cognitive treatment software Welt ‘WELT-I’ was selected as the second digital treatment device in Korea.
The Ministry of Food and Drug Safety approved Welt’s cognitive treatment software ‘WELT-I’ as the second domestic digital treatment device on the 19th.
WELT-I is a software medical device that implements ‘Insomnia Cognitive Behavioral Therapy’ as a mobile app and is licensed for use in improving the symptoms of insomnia patients by increasing sleep efficiency.
Based on the ‘sleep diary’ data recorded by the patient, this product is designed to provide an appropriate personalized bedtime, △intervention in the patient’s behavior to improve sleep quality, △analysis of habits restless sleep, and △ relaxation therapy to reduce tension. and anxiety It is a software medical device with the principle of improving patients’ insomnia by performing back exercises for 6 weeks.
The Ministry of Food and Drug Safety held a ‘Medical Devices Committee’ consisting of mental health experts from the Korean Society of Neuropsychiatry and the Korean Society of Digital Therapy to consult on the safety and efficacy of WELT-I, and undergo a scientific and thorough review. review.
According to the Ministry of Food and Drug Safety, WELT-I is a product subject to the ‘Innovative Medical Device Review and Evaluation System’ (designated as an innovative medical device, ‘22.12.15), which may shorten the period of approval by the Ministry of Food and Drug Safety for use in the medical field by around 80%.
The Ministry of Food and Drug Safety designated WELT-I as an approval assistant (‘21.7.13) and provided ‘guidelines for the evaluation of the safety and performance of digital treatment devices for the treatment of insomnia and the preparation of clinical trial protocols’ (‘21.12) for digital devices handling We have supported rapid productization with close expert support.
Seongji Kang, CEO of Welt, said, “The rapid regulatory establishment of the Ministry of Food and Drug Safety and customized consultations were the driving force behind the rapid release of digital handling devices.”
“We will make domestic regulations a global standard so that domestic companies can continue to develop new technology and innovative products that lead the global market,” said Minister Oh Yoo-kyung of the Ministry of Food Safety and Drugs. We will increase the success rate of product development and accelerate product launches.”