Ainex Corporation (hereinafter “Ainex”), a company specializing in AI for gastroscopy and colonoscopy, recently passed the conformity assessment for European CE certification. The milestone came approximately one year after the company began preparations. Following the adoption of its technology by major hospitals in Singapore, Ainex has now opened the door to Europe, accelerating its international expansion.

The achievement was led by Ainex CEO David Lee, whose professional background is in accounting and business management, with no previous experience in the medical field. We met with Lee to discuss the company’s growth, global business strategy, and future goals.

A Singular Focus on AI for Gastroscopy and Colonoscopy

Ainex develops AI-powered software as a medical device that analyzes endoscopic video to assist clinicians in detecting and diagnosing lesions. The company focuses exclusively on gastroscopy and colonoscopy.

Selected for the Ministry of SMEs and Startups’ Baby Unicorn Program in 2024, Ainex strengthened its commercialization and global expansion capabilities through the Startup Leap Package in 2025. Lee emphasized the importance of “selection and focus.” While first-generation medical AI companies expanded their pipelines across multiple medical specialties before later narrowing their focus, Ainex, considered part of the second generation, concentrated on a single field from the outset.

Ainex’s ENAD product portfolio comprises four solutions: CAD-G, CAD-Gx, CADe, and CADx. CAD-G and CADe detect lesions in real time during gastroscopy and colonoscopy, respectively. CAD-Gx and CADx provide information on lesion types to assist clinicians with diagnosis. ENAD has an all-in-one architecture that supports both detection and diagnostic assistance on a single platform. Screening centers that perform both gastroscopy and colonoscopy can select an integrated configuration.

The regulatory classification differs by product. The detection AI solutions approved in 2023 are Class 2 medical devices, while the diagnostic support AI solutions approved in 2025 are Class 3. According to Ainex, this reflects differences in function and intended use, rather than differences in the performance of the products themselves. Detection AI identifies lesions and highlights suspicious areas, whereas diagnostic support AI also provides information on lesion types and characteristics, giving it a greater potential influence on clinical decision-making. ENAD CADx, a Class 3 device, was designated an Innovative Medical Device in 2025.

The guiding principle behind the product’s design is to avoid disrupting existing examination workflows. “Physicians are particularly reluctant to add new steps to workflows they have followed for decades,” Lee said. “We automated ENAD so that AI could be added to existing practices without requiring separate operation.” Its compatibility with major endoscopy systems and real-time performance were developed with the same principle in mind.

The company has also achieved progress within Korea’s healthcare system. In 2025, ENAD CADx passed the integrated review for Innovative Medical Devices, establishing an institutional foundation for reimbursement for the first time among endoscopy AI solutions. Temporary billing as a non-reimbursed service under the Innovative Health Technology framework became available in January 2026. Under a notice issued by the Ministry of Health and Welfare, the solution was listed under the “AI Analysis and Utilization Fee (Non-Reimbursed)” category as of September 1.

However, this does not mean that the product has completed the process for coverage under Korea’s National Health Insurance. Ainex explained, “Reimbursement coverage will be determined through subsequent evaluations and reviews based on the clinical evidence accumulated over time.”

In public procurement, ENAD and ENAD CADx were designated as Innovative Products by Korea’s Public Procurement Service in 2024 and 2026, respectively. Through pilot procurement programs, the products were supplied to VHS Incheon Hospital, Seoul Metropolitan Government-Seonam Hospital, the Armed Forces Capital Hospital, and the Armed Forces Seoul District Hospital, building references across veterans, municipal, and military hospitals.

Building Trust by Demonstrating Performance Clinically

Lee joined Ainex in 2021 after working at Samil PwC, Youngone Corporation, and Able C&C. He subsequently served as co-CEO before becoming sole CEO in 2024. Although he had experience in market analysis, corporate valuation, global business, and overall management, the medical field was new to him.

Nevertheless, he saw Ainex as a place where his accumulated experience and expertise could come together. “I believed I could contribute by evaluating the potential of the technology from a business perspective, bringing the organization’s capabilities together to turn that technology into products and results, and expanding the business into global markets,” Lee said.

Because he was new to healthcare, it was in hospitals that Lee gained confidence in Ainex’s direction. After joining the company, he met directly with physicians and professors, repeatedly asking what they needed and what level of performance they expected from the product.

His conclusion was straightforward. “I believed it would be difficult for the product to be selected in clinical practice unless its performance exceeded clinicians’ expectations,” Lee recalled. “Developing performance capable of surpassing those high expectations, and proving it through clinical research, became a prerequisite for the business.”

As of September 2026, Ainex had produced 22 research outcomes, including nine papers published in international journals and presentations at academic conferences. Its studies have appeared in publications such as npj Digital Medicine, a Nature Portfolio journal specializing in digital health, and Gut and Liver, the official English-language journal of the Korean Society of Gastroenterology. Ainex has built its evidence through a range of research methods, from model performance evaluations to prospective studies conducted in real-world clinical settings.

A key study was a prospective, multicenter, randomized controlled trial conducted at Ewha Womans University Mokdong Hospital and Korea University Anam Hospital. Among 998 patients, the adenoma detection rate (ADR) was 36.1% in the control group and 52.3% in the AI-assisted group, an increase of 16.2 percentage points. Put another way, for every 100 patients examined, adenomas were detected in approximately 16 more patients when AI assistance was used.

The polyp detection rate (PDR) also increased from 54.5% to 72.2%, while the detection rate for diminutive polyps measuring 1–5 mm, which can be difficult to identify visually, rose from 28.3% to 35.4%.

Adenomas are among the most common precancerous lesions associated with colorectal cancer. Ainex cited previous research indicating that every one-percentage-point increase in ADR is associated with an approximately 3% reduction in colorectal cancer risk. However, the Ainex study itself did not directly measure reductions in colorectal cancer incidence or mortality. The company clarified, “Rather than making definitive claims about preventive effects, the significance of the study lies in the fact that it demonstrated a meaningful improvement in ADR, a key colonoscopy quality indicator.”

Lee also seeks to differentiate Ainex from competing companies through clinical research. “Many companies lack the clinical capabilities or funding required to conduct their own trials and therefore refer to clinical results from other companies,” he said. “We wanted to demonstrate our performance through direct comparison. Physicians in Singapore told us it was the first time they had encountered a company proposing to prove its performance in this way.”

He added, “We could only be selected by demonstrating clinically that our performance exceeded the high expectations of medical professionals.”

Ainex is also conducting clinical collaborations with overseas medical institutions, including the National University Hospital (NUH) in Singapore. The objective is to verify whether the product maintains consistent performance across different patient characteristics and examination environments.

Improving the Product from the User’s Perspective and Accelerating Entry into Europe

While clinical research formed the foundation of trust, Lee personally took responsibility for communicating the results. In the early stages, he visited local hospitals and clinics throughout Korea himself. Feedback gathered from these visits led directly to product improvements.

Lee said he places the user’s perspective above the developer’s perspective. The trust he built with professors also led to clinical collaborations and introductions to overseas hospitals.

Lee continues to lead Ainex’s international expansion. Without relying on local distributors, he personally visits hospitals, gives presentations, participates in equipment installation and on-site observation, and builds relationships with physicians.

Explaining this approach, Lee said, “I believed that having the CEO visit in person was the best way to communicate our sincerity. It also inevitably allows us to move faster.”

His reason for prioritizing global expansion was clear. Major global medical device companies had already communicated the value of AI in endoscopy and established market pricing. Lee concluded that Ainex did not need to create a new market from scratch, but could enter the existing market by competing on performance and ease of use. One of his first decisions after becoming sole CEO was to change the company’s name with global branding in mind.

The results of this hands-on approach have emerged overseas. Singapore serves as a hub for Ainex’s international business. According to Lee, adoption has been confirmed at 12 of approximately 15 major hospitals in the country. Six have completed contracts and are already using the system.

National University Hospital in Singapore reportedly evaluated endoscopy AI systems from around the world before ultimately selecting Ainex’s product. “Many hospitals in Singapore had previously used competing endoscopy AI systems,” Lee said. “Some have replaced their existing products with ours, while others are increasing the number of device subscriptions.”

Ainex has obtained regulatory approvals in seven countries, including Thailand, Singapore, and Malaysia. Singapore’s Health Sciences Authority (HSA) has achieved Maturity Level 4, the highest rating under the World Health Organization’s regulatory maturity assessment framework.

Building on this progress, Ainex has now passed the assessment for European CE certification. The CE mark indicates that a manufacturer has demonstrated that its product complies with the European Union’s safety, health, and performance requirements. It is effectively essential for distributing products in the European market, with medical devices considered one of the most rigorously regulated product categories.

Preparations for the European market are already well underway. Ainex first introduced its product in Europe at UEG Week in the second half of 2025 and participated in a conference in Italy during the first half of 2026.

“We have already established relationships with European hospitals and have been waiting for regulatory approval,” Lee said. “At a conference in Spain later this month, we will begin promoting the product in earnest now that we have passed the CE certification review.”

Pursuing Sustainable Growth

Ainex has grown rapidly. Its products are currently used by approximately 200 medical institutions in Korea. The number of countries in which it holds regulatory approval increased from zero in 2023 to seven in 2026. As of September 2026, the company had approximately 30 employees, nearly three times the little over 10 employees it had in 2024.

Lee attributed the company’s pace of growth to its decision-making structure. He sets the product direction quickly and listens to differing opinions, but decisions are also made promptly. The company also maintains a lean workforce. Lee believes that as headcount increases, greater division of labor becomes necessary, which can weaken focus and slow the organization down.

“Within the company, we connect clinical research, regulatory affairs, and sales through cross-functional projects,” Lee said. “When hiring, we look beyond a candidate’s current abilities and focus on the effort they are willing to make to grow.”

The company’s next goal is to expand in Europe. “Europe is such a large market that we plan to focus there first,” Lee said. “If we succeed, we can expand into the Middle East and other regions. We are also preparing to enter the United States.”

To support this plan, Ainex intends to raise additional funding in 2027 for global expansion. The company has raised approximately KRW 20 billion to date, primarily from Korean venture capital firms. It is targeting an initial public offering between 2028 and 2029.

“Our ultimate goal is to develop and sell the best solution in the world,” Lee said.

“Too many people around us are diagnosed with gastric and colorectal cancer. These cancers are among those for which regular endoscopic screening offers substantial benefits in early detection and prevention. I hope our technology can help reduce the number of lesions missed by clinicians,” he continued. “Through close collaboration with medical professionals, we will continue identifying opportunities where our technology can contribute and pursue sustainable growth.”

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