Fujitsu Limited and DT-Axis Co., Ltd. have announced a collaboration to enhance digital health by developing Software as Medical Device (SaMD) solutions. The partnership aims to support research and development institutions, as well as medical device and pharmaceutical companies, in navigating regulatory approvals and sales processes.
SaMD, which includes therapeutic applications and AI-powered image diagnostics, is poised to play a crucial role in health promotion, preventive medicine, and treatment. Despite global progress in SaMD development and approval, Japan faces challenges in establishing a compliant system design and development framework for commercialization.
To address these challenges, Fujitsu and DT-Axis will leverage their business expertise to assist companies and organizations in creating system development frameworks from initial stages through post-market maintenance. The collaboration aims to improve the quality and speed of SaMD development.
Fujitsu brings its operational expertise and system development know-how in healthcare to the partnership, focusing on programmable medical devices and peripheral systems. The company also provides post-sales system operation and maintenance, along with a Healthcare Personal Service Platform for secure management of personal health information.
DT-Axis, with a track record in obtaining manufacturing and marketing approvals, collaborates with Fujitsu to streamline design, development, and operation processes for programmable medical devices. The focus is on approval applications and sales readiness.
Looking ahead, Fujitsu and DT-Axis plan to explore the establishment of a SaMD distribution platform to support organizations and companies involved in SaMD development. This initiative aims to create an ecosystem that offers comprehensive support from development to distribution, enhancing public well-being.
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