Coreline Soft receives FDA clearance for AI aortic analysis software

Coreline Soft has received FDA 510(k) clearance for its AI-based aortic automatic analysis solution, ‘AVIEW Aorta Metrics’. This marks the company’s 13th FDA clearance, establishing a significant regulatory portfolio among South Korean medical AI firms.

The software utilizes chest CT images to automatically segment the aorta and provide quantitative measurements of anatomical diameters. It supports clinicians through consistent quantitative imaging evaluations, offering features such as Straightened CPR, cross-sectional views, 3D imaging, and quantitative reports.

This achievement expands Coreline Soft’s technological reach from pulmonary diseases—such as lung nodules, COPD, and emphysema—into the cardiovascular domain. The move aligns with the growing trend of ‘opportunistic analysis’ in the U.S. market, where existing CT scans are used to identify additional health risks.

To support commercialization, Coreline Soft has integrated its solutions into ‘Zero-Click’ environments with INFINITT North America and renewed contracts with 3DR Labs. The company also plans to utilize government R&D funding to accelerate further clinical trials and regulatory approvals in the United States.