The approval marks its entry into the $160-billion US medical device market.
South Korean medtech firm Coreline Soft has obtained the United States Food and Drug Administration’s 510(k) clearance for its latest AI-powered analysis software for screening lung nodules.
The company develops AI imaging solutions for diagnosing various chest conditions, aortic disease, spinal disease, and metastatic cancer in the chest.
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WHAT IT DOES
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 disease.
Based on clinical trials in the US, the screening software is able to increase the sensitivity to finding nodules by 34% while decreasing the false positive rate by 42% and the time to read chest CT scans by 70%.
WHY IT MATTERS
This recent FDA approval, which is a first for a Korea-made computer-assisted lung nodule detection software, signals Coreline Soft’s entry into the US medical device market, according to CEO Kim Jin Kook.
The company is seeming to take a piece out of the $163.7 billion revenue that the said market will generate by end-2023 as projected by Statista. Over the next four years, it is expected to reach $200 billion in revenue, growing at a 5% CAGR. Diagnostic imaging devices account for the second largest share in this sector with a projected value of $11.35 billion by the end of the year.
Coreline Soft sees its FDA clearance helping accelerate the approval for AVIEW Lung Nodule CAD in Japan and in other markets requiring FDA or CE approval like the Middle East.
THE LARGER TREND
Late last year, Coreline Soft obtained multiple approvals from Singapore’s Health Sciences Authority for its line of AI imaging software solutions, including its flagship product AVIEW LCS, an AI-enabled automatic pulmonary nodule analysis solution.
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