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Ainex ENAD CAD-Gx Receives Class 3 Medical Device Approval for Real-Time Detection of Early and Advanced Gastric Cancer
Dec.22.2025
Ainex Corporation, a medical artificial intelligence (AI) company, announced on the 22nd that its AI-powered upper endoscopy diagnostic support software has received Class 3 medical device approval from Korea’s Ministry of Food and Drug Safety (MFDS).
ENAD CAD-Gx is a software solution that detects abnormal areas in gastric endoscopy images in real time and immediately displays diagnostic results for a wide range of lesions, including advanced gastric cancer (AGC), early gastric cancer (EGC), gastric adenoma, benign lesions, and intestinal metaplasia (IM).
It is regarded as a next-generation diagnostic support technology that precisely analyzes even subtle lesions that are difficult to detect during conventional endoscopic examinations, thereby supporting clinical decision-making.
In gastric endoscopy, the ability to identify subtle mucosal changes associated with malignant lesions is highly dependent on the examiner’s experience and condition. Trained on a high-quality gastric endoscopy database, ENAD CAD-Gx helps reduce such diagnostic variability and contributes to the standardization of examination quality.
As soon as a lesion is detected, the AI presents probability scores for each lesion type and highlights the most likely diagnosis, enabling clinicians to more clearly determine the need for intervention, follow-up surveillance, and the presence of high-risk lesions.
The clinical value of ENAD CAD-Gx has already been demonstrated in international academic journals. According to a study titled “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 48 out of 55 challenging cases as early gastric cancer. These cases had initially been diagnosed as dysplasia based on biopsy but were ultimately confirmed as early gastric cancer after surgery.
This finding provides important real-world evidence that ENAD CAD-Gx can sensitively identify high-risk lesions and reliably support diagnosis even in cases that are difficult to assess through visual inspection alone.
Ainex expects this regulatory approval to mark a new turning point in improving diagnostic accuracy and standardization in gastric endoscopy.
David Lee, CEO of Ainex, stated, “ENAD CAD-Gx delivers an optimal ‘second opinion’ by enabling AI to precisely analyze even precancerous lesions that are difficult to identify with the naked eye. By providing diagnostic support that can be directly applied to real clinical decision-making, we aim to usher in a new era of AI-powered gastric endoscopy.”
He added, “We will continue to strengthen collaborations with leading medical institutions in Korea and abroad, and expand global regulatory approvals to further enhance ENAD’s competitiveness in gastric cancer diagnosis.”
Ainex has successfully overcome stringent regulatory barriers to establish a presence in advanced healthcare markets such as Singapore. This achievement is commercially significant, as it has opened major export channels spanning five Southeast Asian countries—Singapore, Thailand, Malaysia, Vietnam, and Indonesia—as well as Colombia.
With its technology already validated in overseas markets and reinforced by the recent regulatory approval of its gastric endoscopy AI solution, Ainex plans to accelerate its drive to expand global market share and strengthen its position in the international medical AI landscape.
