[E-Daily Reporter NA EUN-KYUNG ] Coreline Soft Co., Ltd.(384470)has received approval from the U.S. Food and Drug Administration (FDA) for its artificial intelligence (AI)-based aortic analysis software. Following its capabilities for analyzing pulmonary nodules, chronic obstructive pulmonary disease (COPD), and coronary artery calcification (CAC), the company is expanding its business in the U.S. by securing a product lineup capable of analyzing the aorta using chest computed tomography (CT) images.

Coreline Soft Co., Ltd. announced on the 19th that its automated aortic analysis solution, “AVIEW Aorta Metrics,” passed the FDA’s 510(k) premarket notification process on the 16th. With this approval, the company’s total number of FDA 510(k) approvals has increased to 13.

The FDA 510(k) is a procedure that evaluates whether a medical device has safety and performance substantially equivalent to an already approved product, thereby authorizing its sale in the United States. It is distinct from the marketing approval process for new drugs and does not imply that the clinical efficacy of the medical device has been newly demonstrated.

Aview Aorta Metrix is a software-based medical device that automatically segments the aorta in chest CT images and measures its diameter by anatomical segment. It provides quantitative information that enables medical professionals to evaluate the size of the aorta in images using consistent criteria.

Aortic diameter is a key indicator used to assess conditions such as aortic dilation or aneurysms and to track changes in size. An aortic aneurysm is a condition in which a portion of the aorta abnormally expands due to a weakened blood vessel wall; factors such as diameter and the rate of increase are critical in determining whether treatment or follow-up monitoring is necessary.

This FDA approval is significant because it marks Coreline Soft Co., Ltd.’s expansion of its existing chest CT analysis technology from pulmonary diseases into the cardiovascular disease domain. The company already offers AI products that analyze pulmonary nodules, COPD, emphysema, and coronary artery calcification, and has now added aortic quantitative analysis capabilities.

Recently, in the field of medical imaging AI, “opportunistic analysis”—which utilizes previously acquired CT images to assess the risk of other diseases—has been gaining attention. This approach offers the advantage of increasing the utility of imaging data by enabling the extraction of information related to multiple diseases from a single image without the need for additional scans.

In the United States as well, there is a growing trend to integrate such image analysis with clinical care and insurance reimbursement systems. The U.S. Centers for Medicare & Medicaid Services (CMS) has established new HCPCS codes for the algorithmic quantitative analysis of coronary artery calcification and aortic valve calcification (AVC) in chest CT scans. However, these codes do not directly correspond to reimbursement rates for the aortic diameter measurement software recently approved.

Coreline Soft Co., Ltd. is expanding its business in the U.S. not only to secure product approvals but also to integrate AI into the actual image interpretation processes at medical institutions.

In collaboration with the Picture Archiving and Communication System (PACS) company INFINITT North America, the company has established a “Zero-Click” environment where AI analysis is performed within existing PACS systems without requiring separate operations. The company has renewed its contract with the U.S. medical imaging post-processing firm 3DR Labs for the fourth consecutive year, and the client’s annual usage of AView has increased by 60% compared to previous levels.

In the field of lung nodule analysis, the company is working to supply products through “LungOS,” the platform developed by U.S. medical AI firm Optellum. It is also developing a business model with Oatmeal Health to integrate medical imaging AI with clinical care and insurance reimbursement systems.

Recently, the company was selected for the Inter-ministerial Advanced Medical Device R&D Project and plans to receive a total of 2.2 billion won in funding over the next three years to pursue clinical trials in the U.S. and additional FDA approvals.

Coreline Soft Co., Ltd. intends to use this approval as an opportunity to expand the use of its aortic analysis capabilities within its existing U.S. client base, through its teleradiology network and PACS integration environments. However, whether this actually leads to increased revenue will depend on future adoption by medical institutions and an increase in the number of analyses performed.

Kim Jin-guk, CEO of Coreline Soft Co., Ltd., stated, “This FDA approval is significant because it allows us to add a new application area—aortic quantitative analysis—in the U.S. market based on our existing customer base and imaging workflow.” He added, “Going forward, we will expand the scope of application for the eView product line, focusing on remote reading and PACS integration environments at U.S. medical institutions, and strengthen our business foundation to ensure actual usage and repeated adoption.”