Strategy to enter the global medical AI market through overseas clinical trials

In February 2025, CorelineSoft was selected as an outstanding achievement by the Ministry of Health and Welfare and the Korea Health Industry Promotion Agency for the project 'Conducting clinical trials to verify the stability and validity of an AI-based diagnostic aid software medical device for cardiopulmonary diseases in chest CT images and obtaining US FDA certification'.

As of 2025, the domestic R&D budget is about KRW 30 trillion, but every year, the lack of commercialization linkage and revenue performance of R&D projects is pointed out. Recognizing these issues, the Korea Health Industry Promotion Agency plans to promote the R&D and commercialization of innovative medical devices that meet the global regulatory environment through the projects selected as outstanding achievements. The agency proposes a virtuous cycle in which the budget for innovative medical device projects is expanded, and reports that it will continue to support outstanding projects to enter the global market.

Coreline Soft's Research Asset Team is responsible for securing R&D funding and managing technology assets through national research and development projects and government-funded projects. Let's take a look at the background, purpose, and significance of the research that was selected as an outstanding achievement.

Innovative Medical Device Business and Overseas Clinical Challenge

This project was supported by the Technology Commercialization Support Project for Innovative Medical Device Companies (hereinafter referred to as the Innovative Medical Device Project) of the Ministry of Health and Welfare. The Innovative Medical Device Project aims to foster innovative medical device companies certified under Article 10 of the Medical Device Industry Development and Innovative Medical Device Support Act and facilitate their entry into the international market by accumulating overseas clinical data through collaboration with global research institutions.

CorelineSoft, which was certified as an 'innovative medical device company' in December 2021, is considered a representative example of the importance of AI-based medical solutions in the global medical device market. With the goal of securing competitiveness in the domestic and international medical market by conducting clinical trials and obtaining FDA certification, the company conducted overseas clinical assignments for about three years from April 2022 to December 2024.

Key Research Accomplishments and FDA Certifications

1) AVIEW CAC

2) AVIEW Lung Nodule CAD

• Developed technology to automatically detect interpulmonary nodules (IPNs) that can be detected incidentally on cardiac CT
• Differentiated from existing lung nodule detection software
• Completed FDA 510(k) certification application

3) AVIEW Lung Texture

• Developed an algorithm that finely distinguishes between IPF (idiopathic pulmonary fibrosis) and non-IPF, rather than ILD (interstitial lung disease) as a whole
• Go beyond simple diagnosis of lung disease to guide treatment
• Completed FDA 510(k) clearance application

The selection criteria were finalized by analyzing the results achieved through this project, focusing on the relevance to the business purpose, significance and differentiation of the results, impact, and innovation.

CorelineSoft was recognized as a major achievement for securing global competitiveness to enter the North American market through FDA certification (1 case) and certification application (2 cases) by conducting multi-institutional international collaborative research, advancing technology and accumulating overseas clinical data. It was also recognized for enhancing competitiveness in the medical AI field and strengthening its influence in the global medical market based on technical excellence through the project.

Background and Purpose of Overseas Clinical Research

Recently, AI medical software companies, including CorelineSoft, have been accelerating their efforts to conduct overseas clinical trials and research. Their efforts to go beyond the domestic market to the global stage demonstrate their commitment to contribute to medical technology innovation and human health improvement, not just to sell products. So why are AI medical software companies, including CorelineSoft, immersing themselves in overseas clinical research?

1. An 'essential gateway' to global markets

Acquiring overseas clinical data is an essential gateway to the global market. To prove the performance and safety of AI medical software and strengthen global competitiveness, clinical data from various ethnicities and environments is essential to obtain approval from overseas regulatory agencies such as the U.S. Food and Drug Administration (FDA). Overseas clinical studies are like a 'ticket' to the global market.

2. A 'stepping stone' to improve your skills

By conducting various overseas clinical assignments, AI healthcare software companies are able to improve their skills. By acquiring data on various diseases and patients, they can improve their AI algorithms and enhance their technology. In particular, collaborating with overseas research institutions to acquire data on rare or specific diseases is essential. Overseas clinical research is a “growth engine” for AI medical software companies.

3. Opportunities to drive international standardization

Collaborating with overseas research institutes provides an opportunity to drive international standardization of AI medical software and expand their influence in the global healthcare ecosystem. By participating in global AI medical device standardization, the goal is to take the lead in technology development and gain an edge in the global market. Overseas clinical research provides AI medical software companies with an opportunity to gain 'leadership'.

4. The 'key' to securing credibility

Publishing clinical results in reputable journals abroad and presenting at international conferences is crucial to increasing the credibility of the technology and gaining recognition from global medical professionals. For AI healthcare software companies, overseas clinical research is a key component of building “credibility” for their technology.

What the results mean and what to expect in the future

The overseas clinical study proved the potential of AI-based medical devices to enter the global market and secured credibility in the North American market by obtaining and applying for FDA certification. In the future, it is necessary to continue innovating medical AI technology through continued government support and investment in R&D, so that domestic companies can compete in the global medical market.

CorelineSoft will prove the reliability of its technology through national research and development and government support projects and establish itself as a medical AI software company.