[Special Stock] Coreline, Unique Medical AI Recognized by US FDA... Surpassing World No.1 Medical Imaging Diagnosis Technology

Coreline Soft is showing strong performance. The news that it has obtained FDA 510(k) clearance for the advanced version of its proprietary artificial intelligence (AI) software (SW) 'AVIEW CAC' from the U.S. Food and Drug Administration (FDA) appears to be influencing its stock price.

As of 2:08 PM on the 18th, Coreline Soft is trading at 10,950 KRW, up 20.33% from the previous day.

FDA 510(k) is an approval system where the FDA verifies that a product is superior in terms of performance and safety by comparing it to an already approved product. Coreline Soft obtained FDA clearance for AVIEW CAC last year. This time, it also secured new approval for the ‘All New’ version of AVIEW CAC, which optimizes the integration of existing product technology and significantly enhances accessibility.

Coreline Soft plans to strengthen its global market strategy based on FDA certification and world-class AI technology. Recently, an international academic journal demonstrated the superiority of Coreline Soft’s AI technology compared to the world’s number one medical imaging diagnostic company. The advanced version not only provides a comprehensive and stable usage environment but also features enhanced user interface (UI), optimized user experience, and improved communication functions.

AVIEW CAC is an AI-based coronary artery calcification quantification software developed by Coreline Soft. Previously, accurate coronary artery calcification measurement was only possible with cardiac CT (computed tomography). Coreline Soft developed the product to enable quantitative analysis using chest CT as well. Unlike competitor solutions, the FDA approval process validated AI performance by comparing it with expert measurement values rather than simply approving a risk classification method.

A Coreline Soft representative said, "After obtaining FDA clearance for AVIEW CAC last year, we have continuously conducted research and development to advance the AI software’s performance," adding, "We have succeeded in obtaining FDA certification for the advanced version of the product as well."

He continued, "Organizations such as the American College of Radiology recommend coronary artery calcification analysis using chest CT for patients aged 40 and above," and added, "Since AVIEW CAC enables chest CT-based analysis and has received FDA clearance, we expect full-scale entry into the U.S. market."

Furthermore, he emphasized, "Based on our unique AI technology, we plan to improve the performance of our AI software and sequentially obtain FDA certification for the advanced products." He explained, "Following the recent demonstration that our AI software performance is world-class, global market penetration will accelerate through enhanced user convenience and functionality."

Earlier, Coreline Soft demonstrated the excellence of its proprietary AI software ‘AVIEW LCS’ through the international academic journal ‘Scientific Reports,’ a sister journal of ‘Nature.’ This was conducted via a direct comparison with Siemens products, the world’s number one company in the field. Coreline Soft plans to secure a leading position in the global market through continuous AI technology advancement centered on its recently launched AI platforms ‘CORE:ALAP’ and ‘CORE:XAI.’