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Fujitsu Limited and DT-Axis Co., Ltd., a licensed medical device company dedicated to bringing scientific innovation into clinical practice, announced the commencement of a collaboration aimed at advancing digital health. The two companies have signed a memorandum of understanding to provide comprehensive support for the development of 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 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, even with promising research results and technologies applicable to SaMD, challenges remain in establishing a system design and development framework capable of ensuring compliance with regulatory requirements and enabling cross-functional implementation all the way to commercialization.
Leveraging their respective business expertise and achievements, both companies 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 will contribute to improving the quality and speed of SaMD development.
Fujitsu leverages its extensive operational expertise and system development know-how in the healthcare field to develop programmable medical devices and peripheral systems, as well as to provide post-sales system operation and maintenance. Furthermore, 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 continue to explore the establishment of a SaMD distribution platform for the relevant organizations and companies, alongside their SaMD development support. Through this, they aim to build an ecosystem that provides one-stop support from SaMD development to distribution, thereby contributing to the improvement of people's well-being.
Fujitsu’s purpose is to make the world more sustainable by building trust in society through innovation. As the digital transformation partner of choice for customers around the globe, our 113,000 employees work to resolve some of the greatest challenges facing humanity.
DT-Axis is a licensed medical device company dedicated to bringing 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.
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