CorelineSoft Receives Japan PMDA Approval for CT-Based Lung Nodule CAD
核心洞察
CorelineSoft (搜索)'s AVIEW Lung Nodule CAD (搜索) has received PMDA review-based approval, allowing the AI chest CT nodule detection software to enter the Japanese medical device market.
CorelineSoft (搜索) says few CT-based lung nodule (搜索) CAD products have obtained PMDA approval globally and that this is the first such approval from Korea.
The company built a Japanese sales base by acquiring VUNO (搜索)'s VUNO Med-LungCT (搜索) chest CT AI assets last year and now supplies roughly 80 hospitals there.
CorelineSoft (搜索) has obtained Japan PMDA review-based approval for AVIEW Lung Nodule CAD (搜索), medical device software in which artificial intelligence detects candidate lung nodules on chest CT images to assist clinician interpretation. According to the company, few CT-based lung nodule (搜索) CAD products have received PMDA approval globally, and this is the first case from Korea.
Japan's device pathway separates products with established certification standards, which may go through third-party certification, from those requiring individual PMDA review of intended use, performance, safety and effectiveness, and quality materials, followed by Ministry of Health, Labour and Welfare approval. PMDA review-based approval is generally considered the more stringent route.
CorelineSoft (搜索) already has a local commercial base in Japan. Last year it acquired assets related to VUNO (搜索)'s chest CT AI solution VUNO Med-LungCT (搜索), securing an operational base and Japanese distribution channels, and it has since expanded supplies to approximately 80 hospitals. With the approval, the company can add its in-house AVIEW product family to that base. Japan has one of the world's highest CT equipment densities, and rising imaging volumes amid population aging have made specialist interpretation workload an issue. CorelineSoft is extending its AI scope from nodule detection to lung cancer (搜索) screening, comparison with prior images, quantitative analysis and long-term follow-up management.