Coreline Soft bags FDA 510(k) for AI lung cancer detection software

South Korean medical technology company Coreline Soft has obtained 510(k) clearance from the U.S. Food and Drug Administration for its latest AI-powered analysis software for lung nodule screening.

The company develops AI imaging solutions to diagnose various chest conditions, aortic diseases, spinal diseases and metastatic chest cancer.


Its latest software as a medical device called AVIEW Lung Nodule CAD uses AI to detect lung nodules, which are a major indication of the so-called “big three” diseases: lung cancer, chronic obstructive pulmonary disease and cardiovascular.

Based on clinical trials in the United States, the screening software is able to increase the sensitivity for finding nodules by 34% while reducing the false positive rate by 42% and the reading time of chest CT scans by 70%.


This recent FDA approval, which is a first for Korean-made computer-aided lung nodule detection software, signals Coreline Soft’s entry into the US medical device market, according to CEO Kim Jin Kook.

The company seems to take a share of the $163.7 billion in revenue that said market will generate by the end of 2023 as predicted by Statista. Over the next four years, it is expected to reach $200 billion in revenue, growing at a CAGR of 5%. Diagnostic imaging devices make up the second largest share of this sector with a projected value of $11.35 billion by the end of the year.

Coreline Soft Sees FDA Clearance Helping Accelerate Drug Approval AVIEW CAD Lung Nodule in Japan and other markets requiring FDA or CE approval such as the Middle East.


At the end of last year, Coreline Soft obtained several Singapore approvals‘s Health Sciences Authority for its line of AI imaging software solutions, including its flagship product AVIEW LCS, an AI-powered automatic lung nodule analysis solution.

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