Advancing Beyond Detection Toward Clinical Infrastructure
Coreline Soft has initiated a U.S. clinical validation program aimed at supporting FDA clearance and global commercialization of its next-generation AI solutions.
The program includes two products:
• AVIEW IPN, an AI solution designed for opportunistic pulmonary nodule detection on cardiac CT examinations
• AVIEW Lung Metrics, an AI-powered quantitative lung analysis solution supporting imaging-based biomarker development
The initiative is supported through Korea’s national advanced medical device R&D program and is intended to accelerate both clinical validation and regulatory readiness in the United States.
Expanding Opportunities in Cardiac CT
One of the key focuses of the program is the growing role of cardiac CT angiography (CCTA) in routine clinical practice.
As professional societies including the American College of Cardiology (ACC) and American Heart Association (AHA) increasingly recognize CCTA as a frontline diagnostic strategy, examination volumes continue to grow.
While cardiac CT is primarily performed for cardiovascular assessment, the lungs are often included within the imaging field of view. In many cases, potentially significant pulmonary findings may remain outside the primary focus of interpretation.
Coreline Soft's AVIEW IPN is designed to address this opportunity by automatically identifying pulmonary nodules within cardiac CT studies, enabling additional clinical insights from existing imaging data without requiring additional scans.
This approach reflects a broader trend toward opportunistic analysis, where AI helps extract additional value from routinely acquired medical images.
Quantitative Imaging Biomarkers for Lung Disease
The company is also advancing clinical validation of AVIEW Lung Metrics, which provides quantitative assessment of lung abnormalities using AI-assisted imaging biomarkers.
A key feature of the solution is the use of correction-based quantitative metrics designed to reduce variability associated with different scanners and acquisition protocols.
Such standardization may be particularly valuable in multicenter clinical studies and longitudinal patient monitoring, where consistency across imaging environments is essential.
The technology may also support future applications in drug development, where imaging biomarkers are increasingly being explored for disease characterization and treatment response assessment.
Building Clinical Evidence for Real-World Adoption
Coreline Soft has accumulated regulatory and clinical experience across 21 countries and currently holds 12 FDA 510(k) clearances.
The company has also contributed to more than 500 peer-reviewed publications and scientific presentations based on the AVIEW platform.
Through collaborations with institutions including 3DR Labs, Temple Lung Center, and Baylor College of Medicine, Coreline Soft continues to expand clinical validation efforts across multiple healthcare environments.
From AI Validation to Clinical Adoption
"Healthcare providers increasingly expect AI solutions to demonstrate not only technical performance but also clinical utility and economic value," said a spokesperson for Coreline Soft.
"Through this clinical program, we aim to demonstrate how imaging AI can function as scalable clinical infrastructure, supporting routine care, longitudinal monitoring, and future healthcare delivery models."
2026.06.24
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