From “What We See” to “What We Don’t”: Ainex’s ENAD CADx Redefines Colonoscopy with AI

Until now, colonoscopy has primarily focused on identifying visible lesions. With artificial intelligence (AI), however, the field has advanced to the point of detecting even what was once considered “invisible.”

Ainex Corporation’s ENAD CADx is an AI-powered colon cancer detection and diagnostic support software that goes beyond simple lesion detection. It is designed to provide pathological classification across three categories with real-time accuracy.

Specifically, ENAD CADx infers and presents pathological features of: Adenoma/Neoplasm, Hyperplastic Polyp, Serrated Sessile Lesion (SSL)

The system achieves an accuracy rate exceeding 90%.

Recently, ENAD CADx received Class III medical device approval from the Ministry of Food and Drug Safety (MFDS). The company emphasized that this marks a decisive turning point, significantly widening the gap with existing AI endoscopy technologies. While earlier solutions were limited to determining lesion presence or classifying pathology into just two categories, ENAD CADx accurately infers three clinically significant types and displays them on-screen—helping assess malignancy risk and potential progression to cancer.

By distinguishing between adenomas / neoplasms and SSLs (both carrying malignant potential) and hyperplastic polyps (benign, non-progressive), the system enables clinicians to make immediate, evidence-based decisions—whether to proceed with endoscopic resection or continue observation.

Ainex expects ENAD CADx to make a substantial contribution to the early diagnosis of colorectal cancer, not only improving diagnostic accuracy but also reducing unnecessary procedures. Fewer resections of non-neoplastic polyps mean both lower healthcare costs and improved patient safety.

David Lee, CEO of Ainex, commented: “We believe we are standing at a pivotal moment where pathological diagnostics are being redefined around AI. Differentiating polyps into three distinct categories in colonoscopy support was a challenge never attempted before. With the world’s first AI capable of predicting three pathological lesion types, Ainex will lead the global market for AI-powered precision endoscopy diagnostics.”

Ainex is also expanding its footprint in the competitive Southeast Asian market, where Medtronic’s GI Genius, Olympus’s EndoBRAIN-EYE, and Fujifilm’s CAD EYE have strong presences.

According to the company, clinicians in Singapore, Vietnam, Thailand, Malaysia, and Indonesia have adopted ENAD after direct comparisons with other solutions, and usage has been highly active. Its compatibility with all existing endoscopy systems provides a further advantage, enabling faster expansion. Ainex plans to complete approvals and commercialization in more than 10 countries by next year, including markets in Latin America, Australia, Europe, and the United States.