Fujitsu, DT-Axis Collaborate on Digital Health

Fujitsu Limited and DT-Axis Co. Ltd. are teaming up to advance digital health. The pair signed a memorandum of understanding to provide comprehensive support for developing Software as Medical Device (SaMD)—including regulatory approval and sales—for research and development institutions as well as medical device and pharmaceutical companies.

SaMD such as therapeutic applications and artificial intelligence (AI)-powered image diagnostics, are expected to contribute significantly to health promotion, preventive medicine, and treatment, with their development and medical device approval progressing globally. However, in Japan, despite promising research results and SaMD-applicable technologies, challenges remain in establishing a system design and development framework capable of ensuring compliance with regulatory requirements and enabling cross-functional implementation through to commercialization.

Leveraging their respective business expertise and achievements, both Fujitsu and DT-Axis will address these challenges by supporting the relevant companies and organizations in establishing system development frameworks from the initial development stages through post-market operation and maintenance. This collaboration aims to improve SaMD development speed and quality.

Fujitsu will leverage its extensive operational expertise and system development know-how in the healthcare field to develop programmable medical devices and peripheral systems, as well as provide post-sales system operation and maintenance. In response to customer needs, Fujitsu offers the Healthcare Personal Service Platform, a health and medical information management infrastructure enabling secure and reliable management of personal information.

DT-Axis has a proven track record of obtaining manufacturing and marketing approval for programmable medical devices developed by outsourcing manufacturing to Fujitsu. In system development for programmable medical devices, DT-Axis collaborates with Fujitsu to support smoother design, development, and operation processes, with a focus on approval applications and sales readiness.

Going forward, both companies will explore establishing a SaMD distribution platform for the relevant organizations and companies, along with their SaMD development support. Through this, they aim to build an ecosystem that provides one-stop support from SaMD development to distribution. 

Fujitsu is striving to make the world more sustainable. As a digital transformation partner for customers worldwide, its 113,000 employees work to provide a range of services and solutions that draw on five key technologies: AI, Computing, Networks, Data & Security, and Converging Technologies. Fujitsu Limited reported 3.6 trillion yen ($23 billion) for fiscal year 25 (ended March 31, 2025) and is the top digital services company in Japan by market share.

DT-Axis is a licensed medical device company that brings scientific innovation into clinical practice. Founded in 2020 and authorized to manufacture and market medical devices, DT-Axis integrates clinical research, regulatory strategy, and product development to translate research outcomes from academia and industry into real-world healthcare solutions. By bridging academic innovation and medical device commercialization, DT-Axis accelerates the delivery of reliable and innovative healthcare technologies. DT-Axis’s mission is to expand access to the care that patients and clinicians need through the power of technology.