Press release
Europe Software as a Medical Device (SaMD) Market to Reach US$ 1,400.00 million by 2033 | CAGR 14.0% | Key Players - MindMaze, Infermedica, Viz.ai, Inc., Medtronic Plc, and Voluntis
Europe Software as a Medical Device (SaMD) Market Size
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Latest M & A
• Dutch healthcare AI startup Juvoly acquired by Swedish health tech company Tandem Health - expanding voice‐controlled clinical software capabilities across Europe.
• Equasens Group acquired a 90% stake in Calimed SAS, a French cloud‐based medical Practice Management Software provider, enhancing its healthcare software portfolio.
• Swedish AI/clinical documentation specialist Tandem Health continues strategic growth through acquisitions (e.g., Juvoly) to broaden its Europe‐wide clinical software solutions.
Key Players:
Siemens Healthcare Limited, Babylon Healthcare Services Ltd, Koninklijke Philips N.V., MindMaze, Infermedica, Viz.ai, Inc., Medtronic Plc, and Voluntis
Key Development:
January 2026
• European Commission releases updated SaMD regulatory guidance to streamline CE marking process.
• Leading SaMD companies announce strategic partnerships to accelerate AI-driven diagnostics.
• New reimbursement models introduced across key EU markets to support digital therapeutics adoption.
December 2025
• EMA approves first AI-powered SaMD for real-time cardiac monitoring in ambulatory care.
• Increased investments in cybersecurity protocols for SaMDs following new EU data protection mandates.
• EU-funded pilot projects launch to validate interoperability standards across SaMD platforms.
November 2025
• Surge in SaMD clinical trials focusing on personalized medicine applications.
• Regulatory bodies emphasize post-market surveillance enhancements for SaMD safety.
• Major SaMD vendors expand footprints in Central and Eastern Europe markets.
Growth Forecast Projected:
The Europe Software as a Medical Device Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.
Research Process:
Both primary and secondary data sources have been used in the Europe Software as a Medical Device Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.
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Key Segments:
By Application: Disease Management, Diagnostics, Treatment Monitoring, Predictive Health Analytics, Others
By Indication: Diabetes, Mental Health, Oncology, Cardiovascular, Respiratory Conditions, Others
Benefits of the Report:
Chapter 1: Lays the foundation by defining the scope of the report, highlighting core market segments across regions, product types, and applications. It delivers a clear snapshot of current market size, growth potential, and how the industry is expected to evolve in both the near and long term.
Chapter 2: Spotlights the most impactful market insights, unveiling the transformative trends and forces shaping the future of the industry.
Chapter 3: Provides a deep dive into the competitive landscape of , covering revenue shares, strategic initiatives, and notable mergers & acquisitions that are reshaping the market.
Chapter 4: Presents detailed company profiles of leading players featuring financial performance, product portfolios, profit margins, and key milestones that set them apart in the industry.
Chapters 5 & 6: Break down revenue analysis at both regional and country levels, offering precise data on market size, growth drivers, and expansion opportunities across global markets.
Chapter 7: Analyzes the market by product type, spotlighting segment-specific opportunities and helping stakeholders identify untapped, high-growth areas.
Chapter 8 :Explores the market through application-based segmentation, assessing demand across industries and pinpointing downstream sectors with the strongest potential for growth.
Chapter 9: Maps the industry's supply chain in detail, tracing upstream and downstream activities to provide clarity on value creation across the ecosystem.
Chapter 10: Wraps up with a concise summary of the report's key insights distilling the most critical findings and strategic takeaways for decision-makers and stakeholders.
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FAQ
Q1: What is the current size of the Europe Software as a Medical Device Market?
A: The Europe Software as a Medical Device Market was valued at US$ 440.00 million in 2024 and is forecasted to reach US$ 1,400.00 million by 2033
Q2: How rapidly will the Market expand?
A: The Europe Software as a Medical Device market is projected to grow at a CAGR of 14.0% between 2025 and 2033.
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