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Beyond Medicine’s Clickless selected for medical technology evaluation deferral
Beyond Medicine’s digital therapeutic device for temporomandibular disorder (TMD), named ‘Clickless’, has been selected for the new medical technology evaluation deferral program. This selection, announced in September, allows the device to be used in clinical settings to gather real-world data and clinical evidence.
K-MEDI Hub (Daegu-Gyeongbuk Advanced Medical Industry Foundation) has supported the development, technical advancement, and commercialization of Clickless through its digital healthcare medical device demonstration support project since 2024. Beyond Medicine previously received Class 2 digital medical device approval from the Ministry of Food and Drug Safety in December of last year.
The deferral system allows medical technologies that meet certain requirements to bypass immediate evaluation for a set period, facilitating practical clinical application. Beyond Medicine plans to use the data collected in Korea to pursue licensing and commercialization in major international markets, including the United States, Japan, and Europe.
Entities
Beyond Medicine · K-MEDI Hub · Ministry of Food and Drug Safety