Regulatory approval, reimbursement framework and M3 AI distribution network accelerate Japan expansion
Medical artificial intelligence company Coreline Soft has secured official AI software certification from the Japan Radiological Society (JRS) for its lung nodule detection software, AVIEW Lung Nodule CAD, further strengthening its foothold in the Japanese medical market.
The certification follows regulatory approval through Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) last month and provides an additional institutional pathway linking the software to Japan’s diagnostic imaging management and reimbursement framework.
With the JRS certification, medical institutions that meet the facility requirements for Diagnostic Imaging Management Add-ons 3 and 4 can use AVIEW Lung Nodule CAD within a framework that incorporates safety and quality management requirements for AI-assisted diagnostic imaging software.
The certification is expected to support the software’s integration into clinical imaging workflows and its continued use by Japanese medical institutions.
JRS Certification Follows PMDA Approval
Japan’s medical AI market requires a distinction between medical device authorization, professional society-based AI management standards and reimbursement.
PMDA-reviewed approval serves as the regulatory gateway for commercialization as a medical device in Japan. JRS certification, meanwhile, provides an institutional connection to the safety and quality management framework governing AI software used in actual diagnostic imaging practice.
JRS certification is separate from third-party medical device certification conducted by registered certification bodies.
Japan revised its medical reimbursement system in 2022 to incorporate appropriate safety management requirements for AI-based diagnostic imaging support software into facility standards for Diagnostic Imaging Management Add-on 3. The JRS subsequently established a certification system for AI software requiring safety and quality management in clinical imaging environments.
As of Oct. 1, 2026, 45 AI software products were included on the JRS official certification list.
Coreline Soft had previously obtained PMDA approval for AVIEW Lung Nodule CAD. According to the company’s research, it is the first Korean-developed CT-based lung nodule CAD product to receive such approval in Japan.
By securing both regulatory approval and JRS certification within roughly a month, Coreline Soft has moved beyond obtaining permission to commercialize the product and expanded the institutional foundation for its use in Japanese clinical settings.
M3 AI Distribution Expands Portfolio from Lung to Heart
Coreline Soft is simultaneously expanding another part of its Japanese business.
The company recently signed a supply agreement with M3 AI for AVIEW CAC, its cardiovascular imaging detection and diagnostic support software.
Its Japan strategy is therefore developing across three areas: regulatory entry through PMDA approval, connection to the reimbursement framework through JRS certification, and commercialization and distribution through M3 AI.
Japan provides a significant market for medical imaging AI because of its extensive CT infrastructure. The country has more than 115 CT scanners per million people, among the highest levels globally, while the number of physicians per 1,000 people stands at about 2.6, below the OECD average of 3.9.
The combination of high imaging capacity, limited medical personnel and a rapidly aging population is increasing the potential role of AI in supporting diagnostic imaging workflows.
Coreline Soft has also expanded its existing customer base in Japan. Following its acquisition of VUNO’s Japanese chest CT AI assets last year, the company has grown its network to approximately 80 customer hospitals within about a year.
The JRS certification adds another institutional foundation for expanding use of its software among existing and new customers.
Japan Moves Toward Wider LDCT Lung Cancer Screening
Changes in Japan’s lung cancer screening environment could provide another opportunity for medical imaging AI.
Japan’s National Cancer Center has given a Grade A recommendation to low-dose CT, or LDCT, lung cancer screening for high-risk smokers, while the Ministry of Health, Labour and Welfare is conducting demonstration projects in five municipalities this year.
If Japan expands LDCT screening and the use of AI in medical imaging, Coreline Soft plans to leverage its existing regulatory, institutional and distribution infrastructure to increase adoption and usage at hospitals.
The company is also expanding from lung imaging into cardiovascular analysis by offering both AVIEW Lung Nodule CAD and AVIEW CAC in Japan. The strategy is aimed at building a broader chest CT portfolio covering both pulmonary and cardiovascular conditions.
“Following PMDA regulatory approval, we have now secured certification that meets the requirements related to hospital reimbursement, providing clearer incentives for Japanese medical institutions to adopt and continuously use AI,” said Kim Jin-kook, CEO of Coreline Soft.
“In Japan, one of the world’s most CT-intensive healthcare markets, we will use this certification as a foundation to expand real-world utilization of our chest CT portfolio, covering areas from lung to cardiovascular imaging,” Kim said.
