Lunit said Thursday that Lunit INSIGHT MMG, an AI imaging diagnostic solution for mammography, has been selected as a “new medical technology with deferred evaluation” by the National Evidence-based Healthcare Collaborating Agency (NECA) under the Ministry of Health and Welfare.
The new medical technology evaluation deferral system allows new medical technologies that require early adoption to be used in the medical field without reimbursement by deferring evaluation.
It is the first time AI-based image reading assistant software has been classified as subject to the system. Until now, it was common for image reading assistant software to be classified as an existing technology or evaluated as an innovative medical technology due to its similarity in purpose and target audience to the reading by doctors.
After being evaluated as a new medical technology, Lunit was selected for the deferred assessment due to its global clinical data submission utilizing Lunit INSIGHT MMG, which recognized the potential of image reading assistant software to improve diagnostic capabilities and reduce errors.
The company said that as a result, Lunit will be able to advance into the medical field for up to five years, starting in the third quarter of this year.
"As a new medical technology with a deferred evaluation is not limited by the non-reimbursement cap, it gives us a green light for rapid expansion in the domestic market," a Lunit official said.
"NECA’s latest decision enables the non-reimbursed use of Lunit INSIGHT MMG, paving the way for its rapid spread in the medical field," Lunit CEO Seo Bum-seok said. "As the possibility of AI image diagnosis solutions being officially listed in health insurance as a new medical technology has been confirmed, we will continue to take the lead in developing innovative products that contribute to human health through early cancer diagnosis."
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