Coreline Soft said its artificial intelligence (AI)-powered coronary artery calcification automatic diagnostic solution, AVIEW CAC, has received 510(k) clearance from the U.S. FDA.
A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.
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The approval marks the company’s ninth FDA 510(k) clearance, following its initial certification in 2018 for the integrated AI-based product lineup AVIEW.
Other notable FDA approvals include AVIEW LCS (AI-based lung nodule detection analysis software) in 2020 and AVIEW Lung Nodule CAD (AI-based lung nodule detection solution) in 2023.
Coronary artery calcification (CAC) is a primary risk factor for cardiovascular diseases such as angina and myocardial infarction. It can be accurately measured through heart CT scans after adjusting patients’ heartbeats.
The company stressed that the approval of AVIEW CAC is significant as the solution has the ability to analyze CAC in chest CT quantitatively scans without the need for heartbeat adjustment.
In the U.S., the Society of Thoracic Radiology has recommended reporting CAC in chest CT scans for patients over 40 years of age since 2016.
While some software has been FDA-approved for classifying the risk level of coronary artery calcification in chest CT scans, the company stressed that its AVIEW CAC has been acknowledged for its ability to automatically provide quantitative CAC values that are comparable to those measured by professionals.
The company believes that this offers a clinical benefit by enabling the early detection and treatment of cardiovascular diseases, potentially before symptoms occur, by identifying and managing the primary risk factor of coronary artery calcification.
“We are pleased that the FDA recognized our advanced technology and clinical validity,” Coreline Soft CEO Kim Jin-kook said. “AVIEW CAC’s unique ability to detect incidental findings on chest CT, which can provide early warning of abnormalities or reduce the need for additional imaging studies to confirm those abnormalities, will contribute to the early detection and treatment of heart disease.”
Meanwhile, Coreline Soft plans to strengthen the marketing of its cardiovascular product line based on its U.S. subsidiary with the FDA 510k certification.
As its first step, the company will attend ACC 2024 (American College of Cardiology), which will be held for three days in Atlanta, Georgia, starting on Saturday, and will demonstrate various cardiovascular-related products, including AVIEW CAC.
