Coreline Soft Secures 13th FDA 510(k) Clearance for AVIEW Aorta Metrics

Coreline Soft has announced the receipt of FDA 510(k) clearance for its AVIEW Aorta Metrics, an AI-driven software designed for aortic quantitative analysis from chest CT images. The clearance, awarded on October 16, marks the company's 13th FDA 510(k) approval.

AVIEW Aorta Metrics is engineered to automatically segment the aorta and deliver quantitative diameter measurements across various anatomical regions. This software facilitates the classification of aortic zones and accurately measures the diameter for consistent evaluation. Additionally, it offers straightened CPR (curved planar reformation), and provides cross-sectional and 3D views along with comprehensive analysis reports.

This FDA clearance supports Coreline Soft's multi-disease analysis objectives based on chest CT imaging in the U.S. market. Within the medical imaging AI field, there is increasing demand for extracting clinically relevant quantitative data from existing CT scans and integrating this information into established Picture Archiving and Communication Systems (PACS) and radiology workflows. As a result, there is a growing interest in opportunistic screening, enabling the use of current imaging data without additional scans, alongside the potential for quantitative imaging biomarkers.

In response, Coreline Soft's AVIEW platform is designed to analyze and provide insights into multiple diseases and quantitative metrics from a single chest CT scan. Previously released solutions include AVIEW LCS and AVIEW Lung Nodule CAD for lung nodule detection and management, as well as AVIEW CAC for automatic analysis of coronary artery calcium from non-contrast chest CT scans, enabling quantitative scoring and clinical assessments.

The introduction of AVIEW Aorta Metrics extends Coreline Soft's analytical reach beyond pulmonary conditions to incorporate cardiovascular quantitative imaging, including cardiac assessments and coronary artery calcium analysis.

The company's U.S. operations are transitioning from standalone hospital deployments towards more integrated clinical workflows. Coreline Soft is collaborating with INFINITT North America (INA) to develop PACS-integrated, 'zero-click' automation. Furthermore, partnerships with Optellum aim to incorporate AVIEW Lung Nodule CAD into comprehensive lung nodule management strategies, while collaborations with Oatmeal Health focus on lung cancer risk assessment and reimbursement pathways in the U.S.

Coreline Soft plans to showcase its advancements at RSNA 2026, occurring from November 29 to December 3 at McCormick Place in Chicago, Illinois. The company will present its AI solutions for chest CT at AI Showcase Booth #5138 in South Hall, Level 3, demonstrating how quantitative imaging insights can be integrated into practical radiology workflows and multi-disease analyses.