Coreline Soft announced on the 18th that it has advanced its medical artificial intelligence (AI) software "AVIEW CAC" and newly acquired the U.S. Food and Drug Administration (FDA) 510(k) certification.
FDA 510(k) is a system that certifies the efficacy and safety of a product based on its equivalence to existing market devices.
Coreline Soft's AVIEW CAC is an AI-based software medical device that automatically analyzes coronary artery calcification. Following the acquisition of FDA certification last year, the company optimized technological integration and enhanced accessibility through research and development, receiving approval for this new version.
Previously, accurate measurement of coronary artery calcification could only be done through cardiac computed tomography (CT). Coreline Soft developed the product to enable quantitative analysis using chest CT as well. The company demonstrated the AI performance by comparing it to expert measurement figures, leading to this FDA approval.
Coreline Soft plans to strengthen its global market strategy based on FDA certification and world-class AI technology. A company official noted, "This approval will mark the full-scale entry into the U.S. market," adding, "The medical community, including the American College of Chest Physicians, recommends coronary artery calcification analysis in chest CTs for patients over 40 years old."