Lunit's Breast Cancer Diagnosis Solution Selected as "Evaluation Exempt New Medical Technology"

Medical AI company Lunit announced on the 16th that its AI imaging diagnostic solution for mammography, Lunit Insight MMG, has been selected as a 'New Medical Technology with Deferred Evaluation' by the National Evidence-based Healthcare Collaborating Agency (NECA). The deferred evaluation system for new medical technologies allows early adoption of new medical technologies that require prompt introduction by deferring evaluation, enabling their use in medical settings as non-reimbursed services.

Lunit's AI imaging analysis solution for mammography, 'Lunit Insight MMG'
[Photo by Lunit]

This deferred evaluation is the first case where AI-based image reading assistance software has been classified as a new medical technology and received deferred evaluation. Until now, image reading assistance software was generally classified as existing technology or evaluated as innovative medical technology because its reading actions, usage purposes, and targets were similar to those of physicians. However, Lunit Insight MMG was recognized for its potential to significantly improve diagnostic ability and reduce errors through the submission of a vast amount of global clinical data, leading to its selection for new medical technology evaluation and now for deferred evaluation.

Currently, Lunit Insight MMG has been used in the domestic market without separate charges to patients, based on the medical institutions' own needs. However, starting from the third quarter, it will be able to enter the medical field early through non-reimbursed services within the health insurance system for up to five years. Since new medical technologies with deferred evaluation are not subject to limits on non-reimbursed service fees, it is expected to open a green light for rapid expansion in the domestic market. According to global market research firm Mordor Intelligence, the domestic cancer screening and diagnosis market is estimated at 400 billion KRW in total, with breast cancer accounting for 120 billion KRW and lung cancer 280 billion KRW. Lunit plans to actively target the market by promoting Lunit Insight CXR, a chest X-ray AI image analysis solution newly introduced to the non-reimbursed market last month, alongside Lunit Insight MMG.

Seobum Seok, CEO of Lunit, said, "With NECA's decision, the non-reimbursed use of Lunit Insight MMG has become possible, laying the foundation for its rapid spread in medical settings. As the possibility of formal registration in health insurance as a new medical technology for AI imaging diagnostic solutions has been confirmed, we will continue to lead the development of innovative products that contribute to human health through early cancer diagnosis."