Coreline Soft Gains Japan PMDA Approval for Lung Nodule AI
Coreline Soft has secured Japanese regulatory clearance for its AVIEW Lung Nodule CAD, marking a key step in its Asian expansion and doubling its hospital customer base to approximately 80 institutions.
Coreline Soft has obtained approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its AVIEW Lung Nodule CAD software. This clearance allows the medical imaging AI company to formally market its pulmonary nodule detection tool to new healthcare institutions in Japan, adding the country to its list of regulated markets following prior clearances in the United States and Europe.
The approval is significant because it represents the first PMDA clearance for a Korean-developed CT-based lung nodule CAD product. According to Coreline Soft, only three such products have received this specific regulatory status globally, all previously held by major Japanese and global medical device manufacturers. The company cited this regulatory track record as evidence of its ability to adapt its AI technology to diverse clinical and regulatory environments.
Regulatory Review Focuses on Clinical Performance
The PMDA review process, initiated with an application in July 2023, assessed the product beyond algorithm accuracy. The agency evaluated intended clinical use, technical documentation, software verification, risk management, and quality management systems. Coreline Soft provided additional evidence during face-to-face consultations and supplementary procedures to demonstrate that the software’s performance remains consistent across different imaging conditions and real-world hospital environments.
Japan presents a distinct commercial opportunity due to its high density of CT scanners and an aging population that increases radiologist interpretation workloads. The AVIEW software is designed to analyze chest CT scans for pulmonary nodules and quantitative data, supporting longitudinal follow-up by comparing current images with prior studies. This functionality aligns with the local healthcare system’s need for efficient, consistent image interpretation support.
Hospital Network Doubles via VUNO Acquisition
The regulatory clearance complements Coreline Soft’s existing commercial footprint in Japan, which has expanded significantly over the past year. The company acquired assets related to VUNO Med-LungCT, a chest CT AI solution, which provided both an operational product base and established distribution channels. As a result of this acquisition and subsequent business development, the company’s Japanese hospital customer base has nearly doubled, reaching approximately 80 institutions.
Expansion Strategy Relies on Local Partnerships
Looking ahead, Coreline Soft plans to broaden its chest CT AI portfolio in Japan through local distribution channels. The company has identified partnerships with local entities such as M3 AI and Konica Minolta as key strategies for market penetration. By leveraging these established local networks, Coreline Soft aims to accelerate the adoption of its imaging AI tools across the Japanese healthcare sector, further integrating its technology into clinical workflows.
