Coreline Soft Receives U.S. FDA 510(k) Clearance for AVIEW Aorta Metrics, Expanding Its Chest CT AI Portfolio in the U.S.

• Secures its 13th FDA 510(k) clearance, expanding its U.S. portfolio from lung nodule detection and coronary artery calcium (CAC) analysis to quantitative aortic assessment
• Enables automated aortic segmentation and diameter measurements across anatomical regions, broadening the quantitative capabilities of chest CT
• Will showcase the AVIEW platform and its U.S. clinical implementation strategy at RSNA 2026 in November

SEOUL, South Korea and CHICAGO, Oct. 23, 2026 /PRNewswire/ -- Coreline Soft has received U.S. Food and Drug Administration (FDA) 510(k) clearance for AVIEW Aorta Metrics, its AI-powered aortic quantitative analysis software. The clearance, received on October 16, brings the company's total to 13 FDA 510(k) clearances.

AVIEW Aorta Metrics is a software medical device designed to automatically segment the aorta from chest CT images and provide quantitative diameter measurements across anatomical regions. The software automatically classifies aortic zones and measures the diameter of each zone, supporting consistent quantitative evaluation. It also provides straightened CPR (curved planar reformation), cross-sectional and 3D views, and analysis reports.

The latest FDA clearance aligns with Coreline Soft's multi-disease analysis strategy based on chest CT imaging in the U.S. market.

In the U.S. medical imaging AI market, there is growing demand for the ability to extract additional, clinically meaningful quantitative information from existing CT scans and to integrate these insights seamlessly into established Picture Archiving and Communication System (PACS) and radiology interpretation workflows. As a result, interest is rising in Opportunistic screening, which leverages existing imaging data without requiring additional scans, as well as in quantitative imaging biomarkers.

In response to these trends, Coreline Soft has developed its AVIEW platform to analyze multiple diseases and quantitative indicators from a single chest CT scan. AVIEW LCS and AVIEW Lung Nodule CAD support lung nodule detection and quantitative analysis for lung cancer screening and nodule management. AVIEW CAC automatically analyzes coronary artery calcium from non-contrast chest CT scans, delivering quantitative scoring and assessments for clinical interpretation.

With the addition of AVIEW Aorta Metrics, Coreline Soft has further expanded its analytical capabilities in the U.S. market beyond pulmonary disease to encompass cardiovascular quantitative imaging, including CAC and aortic assessment.

Coreline Soft's U.S. business is also evolving beyond individual hospital deployments toward deeper integration with clinical workflows and healthcare platforms.

The company is advancing PACS-integrated, "zero-click" automation in collaboration with INFINITT North America (INA). Coreline Soft is also working with Optellum to explore the integration of AVIEW Lung Nodule CAD into a broader lung nodule management pathway, from detection and risk assessment to follow-up care. Separately, Coreline Soft has collaborated with Oatmeal Health on approaches related to lung cancer risk assessment and U.S. reimbursement pathways.

The FDA clearance of AVIEW Aorta Metrics adds aortic quantitative analysis to Coreline Soft's U.S. chest CT portfolio and provides a regulatory foundation for expanding its quantitative imaging capabilities.

Coreline Soft will also participate in RSNA 2026, taking place from November 29 to December 3 at McCormick Place in Chicago, Illinois. At AI Showcase Booth #5138, located in South Hall, Level 3, the company will present its chest CT-based AI solutions, including AVIEW LCS, AVIEW Lung Nodule CAD, and AVIEW CAC.

Under the theme "From AI Detection to Clinical Implementation," Coreline Soft will demonstrate how quantitative imaging insights can be integrated into real-world radiology workflows, lung cancer screening programs, and multi-disease analysis.