Clickless, a digital therapeutic device for temporomandibular disorders, has been selected for Korea’s new medical technology assessment deferral program, marking a step toward use in actual medical settings. The device was developed by Beyond Medicine with research and commercialization support from the Korea Medical Industry Development Institute, known as K-MEDI hub.
Beyond Medicine received approval last December from Korea’s Ministry of Food and Drug Safety for Clickless as a Class 2 digital medical device. The assessment deferral now gives the company an opportunity to collect real-world use data and additional clinical evidence while the technology is used under the relevant system.
K-MEDI hub has supported Clickless since 2024 through its digital healthcare medical device demonstration support program. Its assistance covered demonstration activities, technology advancement and commercialization. The institute also supported Beyond Medicine’s participation in international medical device exhibitions in Germany late last year and Singapore in September, extending the cooperation from development toward overseas market entry.
- Developer
- Beyond Medicine
- Technology
- Clickless digital therapeutic for temporomandibular disorders
- Device approval
- Class 2 digital medical device approval received last December
- Support program
- K-MEDI hub digital healthcare medical device demonstration support since 2024
Beyond Medicine CEO Kim Dae-hyun said the company plans to use clinical and real-world data collected in Korea as a basis for pursuing regulatory approval and commercialization in the United States, Japan, Europe and other major markets. K-MEDI hub Chairman Park Gu-seon described the assessment deferral as an important transition point for digital therapeutics moving beyond development and approval toward practical clinical use.
The deferral program allows medical technologies that meet requirements such as approval from the food and drug safety authority to postpone a new medical technology assessment for a set period and be used first in medical settings. It is intended to support the accumulation of real-world data and clinical evidence, but selection for deferral is not the same as final recognition of clinical effectiveness or approval as a new medical technology. Temporomandibular disorders involve symptoms such as pain in the jaw joint and chewing muscles, joint sounds and restricted mouth opening.