Ainex's AI colonoscopy software named as innovative medical device by MFDS

Ainex Corporation said Wednesday that its AI-powered colorectal cancer imaging detection and diagnostic support software, ENAD-CADx-01 (ENAD CADx), has been designated as the 94th innovative medical device by the Ministry of Food and Drug Safety (MFDS).

An innovative medical device is defined as one that significantly improves, or is expected to improve, safety and efficacy compared to existing devices or treatments through the application of advanced technology. The designation is granted by the MFDS following an evaluation of technological innovation, safety, and efficacy.

ENAD CADx is an AI software that provides real-time diagnostic results by lesion type during colonoscopy. It detects suspicious areas of colorectal cancer in endoscopic images, highlights them using outlines, colors, or indicator lines, and automatically suggests the likelihood of cancer severity to assist medical professionals in diagnosis.

The software can accurately identify even lesions that are difficult to detect with the naked eye and can differentiate among three types: adenomas, benign polyps, and sessile serrated lesions (SSLs).

“We are pleased that ENAD CADx's technology and clinical validity have been officially recognized,” said Lee Hang-jae, CEO of Ainex. “We will continue to enhance our AI-based endoscopic solutions to enable more accurate and efficient examinations and drive innovation that benefits both healthcare providers and patients.”