INEX Corporation (CEO Lee Hang-jae, hereinafter INEX), a medical artificial intelligence (AI) specialized company, announced that its AI-based colon cancer image detection and diagnosis assistance software (ENAD-CADx-01, hereinafter ENAD CADx) has been designated as an innovative medical device by the Ministry of Food and Drug Safety.
Innovative medical devices are medical devices that have significantly improved or are expected to significantly improve safety and effectiveness compared to existing medical devices or treatments through the application of cutting-edge technology. They are designated by evaluating technological innovation, safety, effectiveness, etc. under the supervision of the Ministry of Food and Drug Safety.
ENAD CADx is AI software that shows the diagnosis results by lesion type in real time during a colonoscopy. It detects areas suspected of colon cancer in the endoscopic image and marks them with outlines, colors, or indicator lines, and automatically provides the degree of possibility of colon cancer severity, etc., and is used to assist medical staff in making diagnostic decisions.
Not only can it accurately detect lesions that are difficult to identify with the naked eye, but it can also diagnose three types: adenomas, benign polyps, and solid-state squamous cell polyps (SSL).
This innovative medical device designation is the result of ENAD CADx's high evaluation in that it can quickly and accurately differentiate various lesions, reduce differences due to the skill level of medical staff or examination environment, and improve the quality of endoscopic examinations.
In particular, as the value of AI-based diagnostic assistance solutions is increasing in the early detection and prevention of digestive cancer, it is expected that creating a more precise and safer endoscopic examination environment will also help in the early diagnosis and treatment of colon cancer.
Through this innovative medical device designation, Inex has further strengthened its technological prowess and leadership in the field of endoscopic AI.
“It is meaningful that the technological prowess and clinical efficacy of ENAD CADx have been officially recognized,” said Lee Hang-jae, CEO of ENEX. “We will continue to strive to enable more accurate and efficient endoscopic examinations through the advancement of AI-based endoscopic solutions, and we will continue to innovate to benefit both medical professionals and patients.”
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