David Lee, CEO of Ainex Corporation
Real-time lesion detection and diagnosis during gastroscopy or colonoscopy
Developing AI software for medical devices to assist medical professionals in making fast and accurate judgments
David Lee (42), CEO of Ainex Corporation, is a global business expert who designed his career to become a professional manager. He has driven change across various industries based on his exceptional strategic thinking and execution capabilities.
ENAD, the company’s flagship product, is an AI software medical device that detects lesions in real time during gastroscopy and colonoscopy examinations. It displays the lesions on the screen to assist healthcare professionals in making quick and accurate judgments. ENAD helps ensure more accurate examinations by preventing lesions from being missed during endoscopy. It was developed through four years of collaborative research and development with Seoul National University Hospital.
Specifically, ENAD is categorized into three solutions: the AI gastric endoscopy lesion detection solution ENAD CAD-G, the AI colonoscopy lesion detection solution ENAD CADe, and the AI colonoscopy lesion diagnosis assistance solution ENAD CADx. In April 2025, ENAD CADx, the AI-based diagnostic assistance software that displays real-time diagnostic results by lesion type, was designated the 95th Innovative Medical Device. It obtained authorization and permission (Class III) in July. Recently, ENAD CADx became the first colonoscopy AI to pass the integrated review for innovative medical devices and enter the fee review process.
The core competitive advantage of AI endoscopic image analysis hinges on the volume and quality of data. ENAD is trained on an original, high-quality database, enabling more precise and accurate examinations. ENAD actively collects diverse lesion data—varying in type, shape, and size—under white light imaging (WLI) and image enhancement modes, such as narrow-band imaging (NBI), to optimize performance for real clinical environments. Furthermore, ENAD offers extensive compatibility, enabling immediate use with various models from major endoscope manufacturers, such as Olympus, Fujifilm, and Pentax, simply by installing the software.
Ainex Corporation’s ENAD CADx is the first software in the world approved for quickly identifying and diagnosing lesions found during colonoscopy as one of three types: adenoma/neoplasm, hyperplastic polyp, or sessile serrated lesion (SSL).
ENAD CADx is officially recognized as the world’s first AI-based colonoscopy diagnostic software to accurately present real-time pathological classification results in three distinct types. Furthermore, ENAD has established itself as a product category eligible for insurance reimbursement.
Ainex Corporation’s AI endoscopic image analysis has positive effects in multiple ways. First, ENAD improves the accuracy of endoscopic examinations. Machine learning–based AI can rapidly and accurately analyze data, detecting subtle changes and patterns that are difficult for the human eye to identify. This significantly improves the accuracy and clinical utility of endoscopic examinations.
Second, ENAD improves the overall quality of endoscopic examinations. Various factors can influence endoscopy, including the skill level and fatigue of the healthcare professional performing the exam and the time of day the exam is performed. Studies indicate that adenoma detection rates can vary by 10–40% between experienced and less experienced physicians, and accuracy may decrease in afternoon examinations compared to morning ones. ENAD’s detection capabilities are on par with those of skilled endoscopy specialists. This enables consistent examination quality regardless of the examiner’s experience level through AI assistance.
Third, ENAD enables the early diagnosis and prevention of gastrointestinal cancers. The adenoma detection rate (ADR) is a key indicator used to evaluate the quality of endoscopic examinations. Adenomas are precancerous lesions that can progress to colorectal and rectal cancers if they grow to approximately 2 cm or larger. Studies show that for every 1% increase in the ADR, the risk of colorectal cancer decreases by 3%. ENAD raises the ADR, which helps recognize and stop lesions before they turn into cancer.
Fourth, ENAD enhances safety and reduces healthcare costs. Studies using ENAD show that when colonoscopies are done with ENAD, which rarely gives false alarms, the non-tumorous lesion resection (NTLR) rate goes down. Reducing the resection of non-tumorous lesions that do not require removal enhances patient safety and positively impacts the cost-effectiveness of healthcare.
Regarding future plans, Lee stated, “Through AI technology, we will provide new medical experiences and contribute to the prevention and early diagnosis of gastrointestinal cancers by offering innovative diagnostic assistance solutions in the gastrointestinal field.”
Founded: November 2019
Main business: development and distribution of ENAD, an AI-based gastrointestinal endoscopy diagnostic assistance software designed to improve endoscopy accuracy and prevent gastric and colorectal cancers
Achievements: Received the Excellence Award in the Gastrointestinal Category at MICCAI 2022 in October 2022; Received the CES 2023 Digital Health Innovation Award in November 2022; Obtained Permission by Item (AI for gastroscopy and colonoscopy, Class II) from MFDS for medical device software and commercialized in July 2023; Selected as a Baby Unicorn by the Ministry of SMEs and Startups in June 2024; Designated as an Innovative Product by the Public Procurement Service in July 2024; Approval by the Thai Food and Drug Administration (TFDA) in February 2025 (AI for gastroscopy and colonoscopy, Class II); Approved by Singapore Health Sciences Authority (HSA) (AI for gastroscopy and colonoscopy, Class B); Approved by Malaysia Medical Device Authority (MDA) (AI for gastroscopy and colonoscopy, Class B) and designated as an Innovative Medical Device for AI-based Software for Assisting in the Detection and Diagnosis of Colorectal Cancer in Medical Imaging in April 2025; Approved by the Colombian National Food and Drug Surveillance Institute (INVIMA) in May 2025 (AI for gastroscopy and colonoscopy, Class IIa); Approved by Indonesia Ministry of Health (MoH) (AI for gastroscopy and colonoscopy detection, Class C); Obtained Permission by Item (AI for colorectal cancer image detection and diagnosis, Class II) from MFDS for medical device software in July 2025; Designated as an Innovative Medical Device under the Integrated Review for AI-based Colorectal Cancer Image Detection and Diagnosis Assistance Software in September 2025; Designated as a New SBA 2025 Hi-Seoul Company in October 2025
reporter jinho lee
jinho2323@hankyung.com
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