The Korea Health Industry Development Institute (KHIDI) announced on the 8th that Ainex Corporation, a KHIDI Innovation Startup Center-supported company, has obtained Class 3 medical device approval from the Ministry of Food and Drug Safety (MFDS) for its artificial intelligence (AI)-based colon cancer lesion detection and diagnostic support software, ENAD-CADx-01 (hereafter ENAD CADx).

Unlike conventional systems that only detect the presence of lesions, ENAD CADx goes further by providing pathological classification into three clinically meaningful categories in real time: Adenoma/Neoplasm, Hyperplastic Polyp, Serrated Sessile Lesion (SSL) 

The system demonstrates an accuracy rate exceeding 90%.

KHIDI explained, “Existing technologies are limited to detecting lesions or classifying them into just two categories. In contrast, ENAD CADx can infer three clinically significant pathological types with high precision, display them on screen, and even help assess the likelihood of malignancy or progression to cancer.”

This enables clinicians to make immediate decisions on whether to proceed with endoscopic resection or continue observation, thereby contributing to the early diagnosis and treatment of colorectal cancer while minimizing unnecessary procedures.

David Lee, CEO of Ainex, stated, “Distinguishing polyps into three categories in colonoscopy diagnostic support is a challenge no one has attempted before. Based on the world’s first AI capable of predicting three distinct pathological lesion types, Ainex will lead the global precision diagnosis market for endoscopic AI.”

According to the company, ENAD CADx is already in use across multiple countries including Singapore, Vietnam, Thailand, Malaysia, and Indonesia, and is highly compatible with existing endoscopy systems. Ainex plans to expand commercialization and regulatory approvals to more than 10 countries by next year, spanning Latin America, Australia, Europe, and the United States, starting from Southeast Asia.