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

South Korean medical tech company Coreline Soft has received US Food and Drug Administration 510(k) approval for its latest AI-based analytic software for lung nodule screening.

The company develops AI-assisted imaging solutions for diagnosing various chest diseases, aortic diseases, spinal diseases, and metastatic chest cancer.

WHAT IT DOES

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

Based on US clinical trials, the screening software is able to increase the sensitivity to detect nodules by 34% while reducing false positive rates by 42% and the time to read chest CT by 70%.

WHY IS IT IMPORTANT

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

It seems that the company is taking a piece from Statista predicts that this market will generate $163.7 billion in revenue by the end of 2023. Over the next four years, revenue is expected to reach $200 billion and a CAGR of 5%. 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 Believes FDA Clearance Helps Speed ​​Up Approval Process AVIEW CAD of lung nodes in Japan and other markets requiring FDA or CE approval such as the Middle East.

BIG TREND

At the end of last year, Coreline Soft acquired Multiple approvals from the Singapore Health Sciences Authority for its line of AI imaging software solutions, including flagship product AVIEW LCS, an automated AI-enabled lung nodule analysis solution.