First Designation of Three Integrated Review Innovative Medical Devices Including Insomnia DTx

Digital Therapeutics (DTx) usage screen of Welt.

[Asia Economy Reporter Kim Young-won] Digital therapeutics (DTx) for insomnia and artificial intelligence (AI) stroke diagnosis support software have been designated as the first innovative medical devices under the integrated review and evaluation system for innovative medical devices.

The Ministry of Health and Welfare and the Ministry of Food and Drug Safety announced on the 15th that AimMed and Welt's insomnia improvement DTx and JLK's AI diagnostic support software have been designated as innovative medical devices. The Ministry of Health and Welfare explained that by the end of October, a total of eight medical devices had applied, and after reviewing seven products that met the screening requirements, three products were designated.

The integrated review and evaluation system for innovative medical devices, established on October 31, is a system designed to improve regulations so that innovative medical devices utilizing AI, big data, and digital technology can be quickly used in medical settings. Previously, the Ministry of Food and Drug Safety designated innovative medical devices, the Health Insurance Review and Assessment Service confirmed the coverage for health insurance benefits, and the Korea Health Technology Assessment conducted evaluations separately by department and institution. However, through integrated review, the relevant ministries and related institutions simultaneously conduct review and evaluation during the designation process of innovative medical devices.

DTx usage screen of AimMed.

Welt and AimMed's chronic insomnia improvement DTx is a software medical device that adapts the standard cognitive behavioral therapy protocol for insomnia into an algorithm within a mobile application (app). After domestic confirmatory clinical trials, it is the first DTx undergoing approval review by the Ministry of Food and Drug Safety. Upon approval completion and the promulgation of the innovative medical technology notice (30 days), it will enter medical practice as a non-reimbursed product (within 3 to 5 years). Approval is expected within this year, so it is anticipated to be available for use early next year.

JLK's stroke diagnosis support software extracts features from patients' magnetic resonance imaging (MRI) images through AI learning and additionally utilizes atrial fibrillation information to assist in classifying types of ischemic stroke. This product, which has already received approval, will enter medical practice as a non-reimbursed product as early as the end of next month after the 30-day innovative medical technology notice period.

Cho Kyu-hong, Minister of Health and Welfare, stated, "The integrated review and evaluation system for innovative medical devices is an exemplary case where the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, and three related institutions actively improved regulations and collaborated to promote advanced technologies in the medical device field such as artificial intelligence and digital technology." He added, "Through this system, we hope to introduce various treatment methods and contribute to enhancing patients' medical benefits."

Usage screen of JLKE's diagnostic assistance software.

This content was produced with the assistance of AI translation services.