INEX ENAD CAD-Gx Obtains Class III Medical Device Approval as Real-Time AI for Early and Advanced Gastric Cancer Detection

INEX Corporation, a company specializing in medical artificial intelligence (AI) led by CEO Lee Hangjae (hereafter referred to as INEX), announced that its AI-based gastroscopy diagnostic support software (ENAD-CADGx-01, hereafter ENAD CAD-Gx) has recently obtained Class III medical device approval from the Ministry of Food and Drug Safety.

ENAD CAD-Gx is software that detects abnormal areas in real time from gastroscopy images and instantly displays diagnostic results for various lesions, including advanced gastric cancer (AGC), early gastric cancer (EGC), adenoma, benign lesions, and intestinal metaplasia (IM), on the screen. It is evaluated as a next-generation diagnostic support technology that precisely analyzes even micro-lesions, which are difficult to detect with conventional endoscopy, thereby assisting clinical decision-making.

The ability to identify subtle mucosal changes in malignant lesions during gastroscopy is greatly influenced by the examiner’s skill and condition. ENAD CAD-Gx, trained on a high-quality gastroscopy database, helps reduce these diagnostic discrepancies and contributes to the standardization of examination quality. As the AI detects lesions, it immediately presents the probability for each lesion type and displays the most likely diagnosis, enabling medical professionals to make clearer decisions regarding the need for procedures, follow-up observation, and assessment of high-risk lesions.

The clinical value of ENAD CAD-Gx has already been demonstrated in international academic journals. According to the study "Real-World Application of Artificial Intelligence for Detecting Pathologic Gastric Atypia and Neoplastic Lesions" published last year in the Journal of Gastric Cancer, ENAD CAD-Gx accurately predicted early gastric cancer in 48 out of 55 challenging cases that were initially diagnosed as dysplasia through biopsy but were ultimately confirmed as early gastric cancer after surgery. This provides important evidence that ENAD CAD-Gx can sensitively identify high-risk lesions and reliably assist in diagnosing lesions that are difficult to assess visually in real clinical settings.

INEX expects this regulatory approval to mark a new turning point for improving the accuracy and standardization of gastroscopy diagnoses. Lee Hangjae, CEO of INEX, stated, "ENAD CAD-Gx provides optimal 'Second Opinion*' to medical professionals by precisely analyzing even precancerous lesions that are difficult to identify visually using AI," and added, "By offering diagnostic support features that can be directly applied to actual clinical decision-making, we will usher in a full-fledged era of AI-based gastroscopy diagnosis." He continued, "We will further strengthen collaboration with major medical institutions at home and abroad and expand global regulatory approvals to enhance ENAD's competitiveness in the field of gastric cancer diagnosis."

INEX has successfully entered advanced medical markets such as Singapore, overcoming challenging regulatory barriers. This is commercially significant as it has established a large export channel spanning five Southeast Asian countries (Singapore, Thailand, Malaysia, Vietnam, and Indonesia) and Colombia.

With its proven technology in overseas markets and the recent approval of its gastroscopy AI solution, INEX is set to accelerate its efforts to expand its global market share and take the lead in the global market.