Japan Software as a Medical Device Market to Reach USD 96.2 Million by 2033, Driven by AI, Cloud, and IoT Healthcare Integration

The Japan Software as a Medical Device Market reached US$ 19.55 million in 2024 and is expected to reach US$ 96.20 million by 2033, growing at a CAGR of 17.3% during the forecast period 2025-2033.

Software as a Medical Device in Japan includes standalone software that performs medical functions like diagnosis, monitoring, or treatment guidance. Growth is driven by digital healthcare adoption, AI integration, and telemedicine demand. Hospitals, clinics, and diagnostic labs are primary end-users. Innovations focus on AI-assisted diagnostics, workflow automation, and regulatory compliance. The Japanese government promotes SaMD through digital health policies. Secure, interoperable software solutions enhance clinical efficiency. Increasing adoption of mobile health platforms supports market growth.

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☛ Japan Software as a Medical Device Market Recent Developments 2025:

✅ In August 2025, Fujifilm Healthcare received regulatory approval for its AI-powered diagnostic software designed to detect early gastrointestinal cancers. The SaMD integrates seamlessly with endoscopic imaging systems for enhanced clinical accuracy.

✅ In July 2025, Canon Medical Systems Corporation launched its deep-learning-based cardiac function analysis SaMD, which automates ejection fraction and ventricular volume measurements using CT data, improving workflow efficiency.

✅ In June 2025, NEC Corporation collaborated with Osaka University Hospital to co-develop AI diagnostic software for lung cancer, leveraging advanced image recognition and cloud-based data sharing for precision oncology.

✅ In May 2025, Hitachi, Ltd. announced the commercialization of its SaMD platform for remote patient monitoring, compliant with Japan's PMDA regulatory framework to support chronic disease management.

✅ In April 2025, Sony Group Corporation initiated clinical validation for a mental health monitoring SaMD that uses voice and facial expression analysis to assess emotional wellbeing, aimed at early intervention in depression care.

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☛ Japan Software as a Medical Device Market Competitive Landscape:

Japan Medical Device Corporation, Nipro Corporation, Micron, Inc., Olympus Medical Systems and Anaut Inc. among others.

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☛ Segments Covered in the Japan Software as a Medical Device Market:

By Application: Disease Management | Diagnostics | Treatment Monitoring | Predictive Health Analytics | Others

By Indication: Diabetes | Mental Health | Oncology | Cardiovascular | Respiratory Conditions | Others

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