Coreline Soft Secures US FDA Clearance Renewal for ‘AI Lung Nodule CAD’

- Meets All Strengthened FDA Requirements, Highlighting Significance of Medical AI Security Certification
- Surpasses 20 US Patents… “Achieved All-Around Excellence in Technology, Security, and Quality”
- Secured Clinical Data, Technology, and Intellectual Property (IP)… Over 2.5 Million Readings in 19 Countries

Coreline Soft (CEO Jin-kook Kim), a leading medical artificial intelligence (AI) company, announced today that it has received 510(k) clearance renewal from the US Food and Drug Administration (FDA) for its AI-based lung nodule detection solution, ‘AVIEW Lung Nodule CAD’. This renewal is particularly significant as it was granted after meeting all of the FDA’s recently strengthened cybersecurity review criteria.

Coreline Soft’s CAD solution had previously received FDA clearance—a first in Korea and fifth globally—after demonstrating superior clinical performance with a △34% increase in lung nodule detection sensitivity, △42% decrease in false positives, and △70% reduction in reading time in 2023. With the increasing network connectivity of medical devices, the FDA has recently mandated security requirements including △security lifecycle management, △submission of Software Bill of Materials (SBOM), △encryption and access control, and △vulnerability response systems. This clearance renewal reaffirms that ‘AVIEW CAD’ is medical AI software meeting these highest international security standards.

Based on technology that simultaneously analyzes lung cancer (lung nodules), emphysema, and coronary artery calcification with a single low-dose CT scan, Coreline Soft’s ‘AVIEW’ platform has had its stability verified, currently processing over 2.5 million clinical data cases across 19 countries worldwide. Notably, it has been selected as the AI solution for government-led lung cancer screening projects in Europe, such as HANSE in Germany, IMPULSION in France, and RISP in Italy, establishing itself as a global standard technology for lung cancer screening.

Coreline Soft additionally acquired three US patents last month, securing a portfolio of over 20 cumulative US patents. The company stated, “This FDA renewal reconfirms our unique position as an AI enterprise satisfying all aspects of technology, security, and quality in the global market. We will broaden our expansion base beyond lung cancer, COPD, and coronary artery disease into the realm of severe vascular diseases.”

Along with strengthening technological barriers to entry, Coreline Soft is targeting overseas markets by building partnerships with global corporations. It is collaborating with Microsoft (MS) and Boehringer Ingelheim, and cooperating with 3DR Labs, the largest image post-processing company in the US, and Temple Lung Center, a leading academic medical institution. Recently, it supplied products to Baylor College of Medicine, part of the world's largest medical cluster, Texas Medical Center (TMC), and entered the reimbursement market through the US healthcare company Oatmeal Health.