[Edaily Reporter NA EUN-KYUNG ] Coreline Soft Co., Ltd.(384470)has secured approval for the manufacture and sale in Japan of its proprietary artificial intelligence (AI) system for detecting pulmonary nodules, following 5 years and 11 months of preparation and review. Although Coreline Soft Co., Ltd. has already been selling the product in Japan, this achievement is significant because, unlike previous “certifications” issued by third-party organizations, it marks the successful completion of an “approval” process in which the Japan Pharmaceuticals and Medical Devices Agency (PMDA) directly evaluated the product’s performance and safety on a case-by-case basis.

In particular, only a very small number of products—including those from Siemens and Fujifilm—have secured such approval in Japan for computer-aided detection (CAD) software for pulmonary nodules. By securing a regulatory foundation for its proprietary pulmonary nodule AI in Japan—following approval by the U.S. Food and Drug Administration (FDA) and the European Union (EU) CE marking—Coreline Soft Co., Ltd. has laid the groundwork for expanding its global thoracic CT AI business.

Performance Proven in Real-World Settings

According to Coreline Soft Co., Ltd. on the 11th, its lung nodule detection AI, “AVIEW Lung Nodule CAD,” recently passed PMDA review and obtained manufacturing and marketing approval from Japan’s Ministry of Health, Labor and Welfare. This product is a Class II medical device that automatically identifies areas suspected of being lung nodules in chest computed tomography (CT) scans to assist medical professionals in their interpretation.

Coreline Soft Co., Ltd. began the regulatory review process in October 2020, underwent preliminary consultations with the PMDA, and submitted a formal application in July 2023. It took 5 years and 11 months to secure approval this September, following multiple rounds of responses to inquiries, in-person consultations, and supplementary procedures.

The review went beyond simply verifying algorithm performance. Coreline Soft Co., Ltd. submitted documentation including the product’s intended use, technical data, test and clinical data demonstrating lung nodule detection performance, software validation data, and risk management and quality-related materials. In accordance with PMDA requirements, the company also provided additional evidence of performance under actual usage environments and imaging conditions.

In Japan, the approval pathway varies not only based on the medical device class but also on the availability of applicable certification standards. While some Class 2 and 3 products with applicable certification standards can receive “certification” from a registered third-party certification body, products to which such standards do not apply are directly reviewed by the PMDA for quality, efficacy, and safety, with the Ministry of Health, Labor and Welfare granting final “approval.”

Of the 581 medical device software products tallied by the PMDA, as of March 2025, 160 (27.5%) were approved, while 421 (72.5%) were certified. When narrowed down to CAD for pulmonary nodules, the number of approved cases is even more limited. According to publicly available PMDA data, manufacturing and marketing approvals have been confirmed for select products, such as Fujifilm’s “FS-AI688” and Siemens’ “syngo.CT Lung CAD.”

Preparations for the Japanese Market Complete… Utilizing M3 AI and Konica Minolta

Under Japan’s Medical Device Act, medical devices cannot be advertised—including their product names, indications, or performance—until they receive approval or certification. With this approval, Coreline Soft Co., Ltd.’s in-house developed “AVIEW Lung Nodule CAD” has been officially recognized in Japan as a “medical device that detects lung nodules to assist physicians in interpretation.” In essence, possessing the technology and having that technology recognized as a medical device for commercialization are separate regulatory processes.

The AVIEW Lung Node CAD is not a product that uses AI to definitively diagnose lung cancer; rather, it is software that identifies suspicious areas in chest CT scans to assist medical professionals in their interpretation. While the existing “AVIEW LCS” analyzes and manages the volume, type, and changes in detected nodules compared to past images, the CAD is responsible for “locating” lung nodules.

A Coreline Soft Co., Ltd. representative explained, “To put it simply, we’ve moved from the stage of ‘having the technology’ to the stage where we can ‘officially describe and sell that technology in Japan as a medical device for detecting pulmonary nodules.’” Whereas previously the product’s functions were described within a limited scope of authorization, the company can now propose it to medical institutions as a CAD system for detecting pulmonary nodules in accordance with its approved intended use.

Having cleared the regulatory hurdles, Coreline Soft Co., Ltd.’s next step is to increase actual hospital adoptions by leveraging its established local sales network. While the PMDA review was underway, the company secured local sales channels, including M3 AI and Konica Minolta. It plans to expand sales of the AView Lung Nodule CAD to new medical institutions while also promoting the transition of existing customers to its own product.

Currently, Coreline Soft Co., Ltd. has established relationships with approximately 80 medical institutions in Japan. Last year, by acquiring assets related to VUNO, Inc.’s chest CT AI solution, “VunoMed Lung CT,” the company secured both a product operations foundation and distribution channels in Japan; since then, it has expanded its customer base by adding new medical institutions.

Actual revenue is expected to materialize sequentially following hospital-specific contracts, installations, and integration with Picture Archiving and Communication Systems (PACS). The company places greater significance on securing the regulatory foundation for the full-scale commercialization of its proprietary products in Japan and laying the groundwork for the entry of subsequent chest CT AI products, rather than short-term revenue.

A Coreline Soft Co., Ltd. official emphasized, “Over the course of about six years, we met PMDA requirements by further validating performance under actual usage environments and imaging conditions,” adding, “This is significant not merely as the addition of another Japanese approval, but because we have cleared the regulatory hurdle necessary to formally commercialize our proprietary pulmonary nodule CAD in Japan.”