Coreline Soft, a company specializing in medical AI solutions, said on Friday that its AI-based lung nodule detection solution, AVIEW Lung Nodule CAD, has obtained FDA 510(k) clearance.

This is the first AI-based lung nodule detection CAD in Korea and the fifth in the world to obtain U.S. FDA 510(k) approval.

A 510(k) clearance is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective. It also proves that the device is substantially equivalent to a legally marketed device.

Lung cancer is the leading cause of cancer mortality, and early diagnosis is important. In particular, lung nodule detection analysis is the first step in preventing lung cancer. However, it is often difficult to detect lung nodules in patients due to nodules attached to the pleura or other structures such as blood vessels and hearts.

Coreline Soft's lung nodule detection device was recognized for its performance and effectiveness in various patients at U.S. clinical sites. Clinical trials showed that when U.S. radiologists used CAD, the sensitivity to finding nodules increased by 34 percent, the false positive rate decreased by 42 percent, and the time required to read the medical images decreased by 70 percent.

It was also effective when applied to assist the reading of general chest CT images to scan for other diseases.

A Coreline Soft official said,  by securing FDA approval for the “Big-3 diseases” including lung cancer, chronic obstructive pulmonary disease, and cardiovascular disease, the company was able to increase competitiveness in screening multiple diseases with a single chest CT scan.

This FDA approval is expected to bring ripple effects to accelerate approval in Japan as well as other markets requiring FDA or CE approval like the Middle East, the company said. 

"Through this FDA approval, we have successfully settled in the U.S. medical market, " said Coreline Soft CEO  Kim Jin-kook. "We expect all-round business synergy, including sales, and increased momentum for our upcoming IPO."