Approval of 'Lunit Insight CXR' as Innovative Medical Device in Integrated Review... "Expecting Reimbursement in Q1 Next Year"

Medical AI company Lunit's chest X-ray AI image analysis solution, 'Lunit Insight CXR,' has been recognized by the government as an innovative medical device.

Lunit's chest X-ray AI imaging analysis solution 'Lunit Insight CXR' (left) and mammography AI imaging analysis solution 'Lunit Insight MMG'. [Photo by Lunit]

On the 17th, Lunit announced that Lunit Insight CXR was designated as an innovative medical technology through the Ministry of Health and Welfare's 'Integrated Review and Evaluation of Innovative Medical Devices' notice. According to the Ministry of Health and Welfare's 'New Medical Technology Safety and Effectiveness Evaluation Results' notice released together, Lunit Insight CXR can be used in clinical medical settings as an innovative medical technology with safety and potential from March next year until February 2027 for three years.

Innovative medical technology is a system established by the Ministry of Health and Welfare and the National Evidence-based Healthcare Collaborating Agency (NECA) to promote the utilization of promising future technologies. When the potential value of safety and effectiveness of innovative medical technology is recognized, it is allowed to temporarily enter the medical market to verify and formally register it, encouraging market entry of innovative medical technologies. In particular, the Ministry of Health and Welfare integrated the existing innovative medical technology designation procedures, which previously required processes such as medical device approval by the Ministry of Food and Drug Safety (up to 80 days) and innovative medical technology evaluation by NECA (up to 250 days), which had been criticized for taking a long time, so that all processes can be completed within 80 days.

Through this integrated review and evaluation, Lunit Insight CXR, which completed all procedures including the Ministry of Food and Drug Safety's 'Reconfirmation of Existing Innovative Medical Device Designation,' the Health Insurance Review and Assessment Service's 'Confirmation of New Medical Technology Evaluation Application Target,' and NECA's 'New Approval of Innovative Medical Technology (NECA),' can enter the selective reimbursement or non-reimbursement market for the next three years. Lunit plans to prepare for the application of the national health insurance system, such as selective reimbursement or non-reimbursement for AI medical devices, starting as early as March next year when the notice is enforced, after going through the Health Insurance Review and Assessment Service's temporary registration procedures. Subsequently, based on the real-world evidence (RWE) secured during this period, Lunit plans to undergo a re-evaluation of the new medical technology evaluation within three years and proceed with formal health insurance registration.

Lunit is also proceeding with procedures for insurance fee application, such as applying for the integrated review and evaluation of innovative medical devices this month for another core product, the mammography AI image analysis solution 'Lunit Insight MMG.'

Seobum Seok, CEO of Lunit, said, "With the approval of innovative medical technology achieved through Lunit's solid research results, the chest X-ray AI product is the first to enter health insurance, which is expected to expand the base of AI solutions and significantly increase profitability. We expect that once the integrated review and evaluation is completed, the product receiving fee application will be actively deployed in medical settings as early as the first quarter of next year, giving momentum to our business."

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