Ainex Endoscopy AI ENAD Clears European CE Review

Ainex Corporation has passed the European CE certification review for its gastrointestinal and colorectal endoscopy AI software, the company announced. ENAD, its endoscopy AI product line, underwent roughly one year of preparation ahead of the review.

Ainex's ENAD line consists of four products: CAD-G, CAD-Gx, CADe and CADx. The CE review result covers the company's endoscopy AI software, according to it.donga.com.

The company has also built a hospital base in Singapore. Its National University Hospital selected an Ainex product after testing endoscopy AI products from around the world. Of about 15 major hospitals in Singapore, adoption was confirmed with 12, and 6 have completed contracts and are already running the product.

Ainex has obtained regulatory approvals in seven countries, including Thailand, Singapore and Malaysia. Overseas licensing countries increased from zero in 2023 to seven in 2026, and domestic adopting medical institutions now number about 200.

Background

In 2023, ENAD's detection AI received grade 2 approval, and the diagnosis support AI received grade 3 approval in 2025. In 2025, ENAD CADx was designated as an innovative medical device and passed the integrated review. From January 2026, temporary non-reimbursed claims became possible under innovative medical technology, and from September 1 it was listed under the "AI analysis and utilization fee (non-reimbursed)" item per a Ministry of Health and Welfare notice. In 2024 ENAD and in 2026 ENAD CADx were designated as Public Procurement Service innovative products. As of September 2026, Ainex had produced nine international journal papers and 22 total research outputs, and employees numbered about 30, up roughly threefold from about 10 in 2024.