Coreline Soft, a medical imaging artificial intelligence company, has cleared a major regulatory hurdle in Japan, laying another foundation for its global expansion.

Japan is widely regarded as a challenging market for overseas medical AI companies, with its medical device approval process assessing not only product performance but also intended clinical use, quality management systems and suitability for the local healthcare environment.

The significance of the approval goes beyond gaining the ability to market a product in Japan. Following regulatory clearances in the United States and Europe, Coreline Soft has now added Japan to its regulatory track record, demonstrating its ability to adapt and commercialize its AI technology across different healthcare and regulatory environments.

Japan also has one of the world’s highest levels of CT scanner availability. Combined with an aging population and a growing interpretation workload for radiologists, this creates significant potential for medical imaging AI.

That environment closely aligns with Coreline Soft’s strategy of using a single chest CT scan to analyze pulmonary nodules and other quantitative information while supporting comparison with prior images and longitudinal follow-up.

PMDA Review Marks First for a Korean-Developed Product

Medical devices in Japan follow different regulatory pathways depending on their characteristics and intended use, including third-party certification and approval based on review by the Pharmaceuticals and Medical Devices Agency (PMDA).

Certain products covered by established certification standards can be assessed by registered certification bodies. Products requiring separate approval, however, undergo individual review of their intended use, performance, safety, efficacy and quality-related documentation by the PMDA before approval by Japan’s Ministry of Health, Labour and Welfare.

AVIEW Lung Nodule CAD went through this PMDA review process.

According to Coreline Soft’s research, it is the first Korean-developed CT-based lung nodule CAD product to receive PMDA approval in Japan, while only a small number of global companies have received similar approval. The limited number of precedents, which have largely involved major Japanese and global medical device companies, underscores the relative rarity of the approval.

Review Covers Clinical Performance and Real-World Use

Coreline Soft formally submitted its application in July 2023 and subsequently responded to PMDA inquiries through face-to-face consultations, additional documentation and final supplementary procedures.

The review covered the product’s intended use and technical documentation, testing and clinical data demonstrating pulmonary nodule detection performance, software verification, risk management and quality-related materials.

The company also provided additional evidence that performance could be maintained across different imaging conditions and real-world use environments. The process therefore assessed not only algorithm accuracy but also clinical evidence, software reliability, quality management and safety.

AVIEW Lung Nodule CAD is medical device software designed to detect pulmonary nodule candidates on chest CT images and assist physicians in image interpretation.

With the approval, Coreline Soft now has the regulatory basis to formally offer its lung nodule detection CAD to new medical institutions in Japan and expand commercialization activities.

Hospital Customer Base Reaches About 80

The approval carries additional significance because Coreline Soft has already established a commercial presence in Japan.

Last year, the company acquired assets related to VUNO Med-LungCT, VUNO’s chest CT AI solution, gaining both an operational product base and distribution channels in Japan.

Coreline Soft has since expanded beyond the inherited customer base, securing deployments at approximately 80 hospitals. According to the company, its hospital customer base has nearly doubled in about a year following the acquisition.

The expansion suggests that Coreline Soft has used existing distribution networks and customer relationships not simply to maintain the acquired business but to broaden its presence in the Japanese market.

The PMDA approval now allows the company to add its own AVIEW portfolio to that foundation.

While the approval does not automatically translate into immediate revenue from existing customers, it enables Coreline Soft to formally propose its approved lung nodule CAD to new medical institutions.

The company has already established local sales channels with companies including M3 AI and Konica Minolta. Instead of building its distribution network and customer base from scratch following regulatory approval, Coreline Soft can now introduce its own approved products through an existing commercial infrastructure.

Its Japanese business is therefore expected to evolve from operations centered on VUNO Med-LungCT toward a broader chest CT AI portfolio that includes Coreline Soft’s own AVIEW products.

Japan’s CT Infrastructure Adds Strategic Value

Japan ranks among the countries with the highest density of CT scanners worldwide. As its population ages and demand for cancer and chronic disease management increases, growing imaging volumes and radiologists’ workloads have become important challenges for the healthcare system.

In a market where CT equipment is already widely available, the focus increasingly shifts from adding scanners to extracting clinically meaningful information from existing images more efficiently, quantifying findings and managing them consistently across repeated examinations.

That direction closely matches Coreline Soft’s broader chest CT strategy.

The company has expanded its AI capabilities from pulmonary nodule detection into lung cancer screening, prior-image comparison, quantitative analysis and long-term follow-up management. It is also developing its portfolio toward extracting information on multiple diseases and risk factors from a single chest CT examination.

Securing regulatory pathways for its own products in Japan, following the U.S. FDA and European CE, could also strengthen the company’s longer-term position. In medical AI, competitiveness increasingly depends not only on developing algorithms but also on the ability to validate, localize and deploy them across different regulatory and clinical environments.

“We will expand the real-world use of our lung cancer screening and chest CT AI portfolio based on the hospital customer base and business experience we have already established in Japan,” said Coreline Soft CEO Kim Jin-kook.

“Chest CT AI is evolving beyond detecting a single lesion toward supporting lung cancer screening and follow-up management while extracting information on various chest diseases and risk factors,” Kim added. “We will continue expanding our chest CT AI portfolio in Japan so that medical institutions can derive more clinical information from existing images.”