Ainex Corporation, a leading company in gastrointestinal endoscopy AI solutions, announced that its artificial intelligence–based lesion diagnostic support software ENAD CADx has successfully passed the Integrated Review for Innovative Medical Devices by the Ministry of Food and Drug Safety (MFDS).

This milestone comes just two months after ENAD CADx was designated as an Innovative Medical Device (General Review) in April and subsequently received regulatory approval in July. It marks the first-ever entry into the reimbursement process for endoscopy AI in Korea—a rare achievement even globally, with only a few countries such as Japan recognizing reimbursement codes for AI diagnostic devices.

According to MFDS data released on the 22nd, only 28 of the 112 devices designated as Innovative Medical Devices fall under the integrated review system, with ENAD CADx being the first in the colonoscopy AI category.

The Integrated Review designation allows MFDS and the Ministry of Health and Welfare to conduct parallel evaluations of clinical value, reimbursement eligibility, and non-reimbursement status, significantly reducing the time to market. Through this, ENAD CADx has officially entered the process for determining the scope of reimbursement coverage. The final decision on reimbursement classification will be made by the Health Insurance Review and Assessment Service (HIRA).

Having already proven its market viability with paid adoption in over 130 hospitals in Korea within just two years of commercialization, ENAD is expected to see its uptake accelerate further once formal reimbursement is applied to CADx products.

An Ainex spokesperson stated, “The integrated review approval represents institutional recognition of ENAD CADx’s clinical and technological value. We aim to strengthen our leadership in the domestic endoscopy AI market while also accelerating our expansion in global markets.”

CEO David Lee added, “The value of ENAD goes beyond improving diagnostic accuracy. By reducing disparities in endoscopy quality and supporting physicians in providing more precise diagnosis and treatment, ENAD will help drive both improved healthcare accessibility and a paradigm shift in cancer diagnostics.”

ENAD is an AI-powered software solution that assists gastroenterologists during colonoscopy by detecting lesions in real time and providing classification support. By minimizing diagnostic variability caused by differences in physician expertise or procedural conditions, ENAD contributes to more reliable examinations and supports the prevention and early detection of colorectal cancer.