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Software as a Medical Device (SaMD)
SaMD is software that performs one or more medical functions. While the software may be embedded in a piece of hardware (as is often the case) it's the software itself that performs the medical function.
Product & engineering
Understand the product.
SaMD is software that performs one or more medical functions. While the software may be embedded in a piece of hardware (as is often the case) it's the software itself that performs the medical function.
Selected research
Industry Research
Software as a Medical Device (SaMD) Industry Research Report 2026
Market perspective
SaMD is software that performs one or more medical functions. While the software may be embedded in a piece of hardware (as is often the case) it's the software itself that performs the medical function.
According to types, the most proportion of the Global Software as a Medical Device market share is Cloud-based, taking about 67.34% share of global market in 2020. The most proportion of the Global Software as a Medical Device market share is used for Monitoring and Alerting and the proportion is about 41.55% in 2020.
Report Scope
Read the full market overview
This report quantifies the global Software as a Medical Device (SaMD) market in terms of revenue (US$ million) and, where applicable, service volume (K Units), using 2024 as the base year and providing annual historical and forecast data for 2021–2032.
It standardizes definitions of service Types and end-use Applications, harmonizes provider attribution, and delivers comparable time series by company, Type, Application, and region or country, including indicative price bands (US$/K Units) and concentration ratios (CR5/CR10). Outputs are intended to support service design, budgeting, capacity planning, and benchmarking for providers, platforms, channel partners, and investors; the report also reviews technology shifts and notable service innovations relevant to Software as a Medical Device (SaMD).
Key Companies & Market Share Insights
This section profiles leading service providers with 2021–2025 results and a 2026–2032 outlook—covering revenue, market share, price bands, service portfolio and client mix, regional and channel mix, and key developments (M&A, network expansion, certifications). It also provides global revenue, average price, and—where applicable—volume metrics by provider, and calculates CR5/CR10 and rank changes to support comparative benchmarking.
Software as a Medical Device (SaMD) Market by Company
MindMaze
Medtronic
Viz.AI.
Siemens Healthcare
iSchemaView
Arterys
Adherium
Digital Diagnostics
Allscripts
Software as a Medical Device (SaMD) Segment by Type
Cloud-based
On Premise
Software as a Medical Device (SaMD) Segment by Application
Screening and Diagnosis
Monitoring and Alerting
Chronic Disease Management
Other
Software as a Medical Device (SaMD) Segment by Region
North America
United States
Canada
Mexico
Europe
Germany
France
U.K.
Italy
Spain
Russia
Netherlands
Nordic Countries
Asia-Pacific
China
Japan
South Korea
India
Australia
Taiwan
Southeast Asia
South America
Brazil
Argentina
Chile
Middle East & Africa
Saudi Arabia
Israel
United Arab Emirates
Turkey
Iran
Egypt
Key Drivers & Barriers
High-impact rendering factors and drivers have been studied in this report to aid the readers to understand the general development. Moreover, the report includes restraints and challenges that may act as stumbling blocks on the way of the players. This will assist the users to be attentive and make informed decisions related to business. Specialists have also laid their focus on the upcoming business prospects.
Reasons to Buy This Report
1. This report will help the readers to understand the competition within the industries and strategies for the competitive environment to enhance the potential profit. The report also focuses on the competitive landscape of the global Software as a Medical Device (SaMD) market, and introduces in detail the market share, industry ranking, competitor ecosystem, market performance, new product development, operation situation, expansion, and acquisition. etc. of the main players, which helps the readers to identify the main competitors and deeply understand the competition pattern of the market.
2. This report will help stakeholders to understand the global industry status and trends of Software as a Medical Device (SaMD) and provides them with information on key market drivers, restraints, challenges, and opportunities.
3. This report will help stakeholders to understand competitors better and gain more insights to strengthen their position in their businesses. The competitive landscape section includes the market share and rank (in volume and value), competitor ecosystem, new product development, expansion, and acquisition.
4. This report stays updated with novel technology integration, features, and the latest developments in the market
5. This report helps stakeholders to gain insights into which regions to target globally
6. This report helps stakeholders to gain insights into the end-user perception concerning the adoption of Software as a Medical Device (SaMD).
7. This report helps stakeholders to identify some of the key players in the market and understand their valuable contribution.
Chapter Outline
Chapter 1: Research objectives, research methods, data sources, data cross-validation;
Chapter 2: Introduces the report scope of the report, executive summary of different market segments (product type, application, etc), including the market size of each market segment, future development potential, and so on. It offers a high-level view of the current state of the market and its likely evolution in the short to mid-term, and long term.
Chapter 3: Provides the analysis of various market segments product types, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter 4: Provides the analysis of various market segments application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter 5: Introduces executive summary of global market size, regional market size, this section also introduces the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by companies in the industry, and the analysis of relevant policies in the industry.
Chapter 6: Detailed analysis of Software as a Medical Device (SaMD) companies’ competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc.
Chapter 7, 8, 9, 10, 11: North America, Europe, Asia Pacific, South America, Middle East and Africa segment by country. It provides a quantitative analysis of the market size and development potential of each region and its main countries and introduces the market development, future development prospects, market space, and capacity of each country in the world.
Chapter 12: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including revenue, gross margin, product introduction, recent development, etc.
Chapter 13: The main points and conclusions of the report.
More report detail
Tables and figures
Scope & coverage.
Types
- Cloud-based
- On Premise
Applications
- Screening and Diagnosis
- Monitoring and Alerting
- Chronic Disease Management
- Other
Companies covered
- MindMaze
- Medtronic
- Viz.AI.
- Siemens Healthcare
- iSchemaView
- Arterys
- Adherium
- Digital Diagnostics
- Allscripts
Inside the report.
1 Preface
- 1.1 Scope of Report
- 1.2 Reasons for Doing This Study
- 1.3 Research Methodology
- 1.4 Research Process
- 1.5 Data Source
- 1.5.1 Secondary Sources
- 1.5.2 Primary Sources
2 Market Overview
- 2.1 Product Definition
- 2.2 Software as a Medical Device (SaMD) by Type
- 2.2.1 Market Value Comparison by Type (2021 VS 2025 VS 2032)
- 2.2.2 Cloud-based
- 2.2.3 On Premise
- 2.3 Software as a Medical Device (SaMD) by Application
- 2.3.1 Market Value Comparison by Application (2021 VS 2025 VS 2032)
- 2.3.2 Screening and Diagnosis
- 2.3.3 Monitoring and Alerting
- 2.3.4 Chronic Disease Management
- 2.3.5 Other
- 2.4 Assumptions and Limitations
3 Software as a Medical Device (SaMD) Breakdown Data by Type
- 3.1 Global Software as a Medical Device (SaMD) Historic Market Size by Type (2021-2026)
- 3.2 Global Software as a Medical Device (SaMD) Forecasted Market Size by Type (2027-2032)
4 Software as a Medical Device (SaMD) Breakdown Data by Application
- 4.1 Global Software as a Medical Device (SaMD) Historic Market Size by Application (2021-2026)
- 4.2 Global Software as a Medical Device (SaMD) Forecasted Market Size by Application (2027-2032)
5 Global Growth Trends
- 5.1 Global Software as a Medical Device (SaMD) Market Perspective (2021-2032)
- 5.2 Global Software as a Medical Device (SaMD) Growth Trends by Region
- 5.2.1 Global Software as a Medical Device (SaMD) Market Size by Region: 2021 VS 2025 VS 2032
- 5.2.2 Software as a Medical Device (SaMD) Historic Market Size by Region (2021-2026)
- 5.2.3 Software as a Medical Device (SaMD) Forecasted Market Size by Region (2027-2032)
- 5.3 Software as a Medical Device (SaMD) Market Dynamics
- 5.3.1 Software as a Medical Device (SaMD) Industry Trends
- 5.3.2 Software as a Medical Device (SaMD) Market Drivers
- 5.3.3 Software as a Medical Device (SaMD) Market Challenges
- 5.3.4 Software as a Medical Device (SaMD) Market Restraints
6 Market Competitive Landscape by Players
- 6.1 Global Top Software as a Medical Device (SaMD) Players by Revenue
- 6.1.1 Global Top Software as a Medical Device (SaMD) Players by Revenue (2021-2026)
- 6.1.2 Global Software as a Medical Device (SaMD) Revenue Market Share by Players (2021-2026)
- 6.2 Global Software as a Medical Device (SaMD) Industry Players Ranking, 2023 VS 2024 VS 2025
- 6.3 Global Key Players of Software as a Medical Device (SaMD) Head Office and Area Served
- 6.4 Global Software as a Medical Device (SaMD) Players, Product Type & Application
- 6.5 Global Software as a Medical Device (SaMD) Manufacturers Established Date
- 6.6 Global Software as a Medical Device (SaMD) Market CR5 and HHI
- 6.7 Global Players Mergers & Acquisition
7 North America
- 7.1 North America Software as a Medical Device (SaMD) Market Size (2021-2032)
- 7.2 North America Software as a Medical Device (SaMD) Market Growth Rate by Country: 2021 VS 2025 VS 2032
- 7.3 North America Software as a Medical Device (SaMD) Market Size by Country (2021-2026)
- 7.4 North America Software as a Medical Device (SaMD) Market Size by Country (2027-2032)
- 7.5 United States
- 7.5 United States
- 7.6 Canada
- 7.7 Mexico
8 Europe
- 8.1 Europe Software as a Medical Device (SaMD) Market Size (2021-2032)
- 8.2 Europe Software as a Medical Device (SaMD) Market Growth Rate by Country: 2021 VS 2025 VS 2032
- 8.3 Europe Software as a Medical Device (SaMD) Market Size by Country (2021-2026)
- 8.4 Europe Software as a Medical Device (SaMD) Market Size by Country (2027-2032)
- 8.5 Germany
- 8.6 France
- 8.7 U.K.
- 8.8 Italy
- 8.9 Spain
- 8.10 Russia
- 8.11 Netherlands
- 8.12 Nordic Countries
9 Asia-Pacific
- 9.1 Asia-Pacific Software as a Medical Device (SaMD) Market Size (2021-2032)
- 9.2 Asia-Pacific Software as a Medical Device (SaMD) Market Growth Rate by Country: 2021 VS 2025 VS 2032
- 9.3 Asia-Pacific Software as a Medical Device (SaMD) Market Size by Country (2021-2026)
- 9.4 Asia-Pacific Software as a Medical Device (SaMD) Market Size by Country (2027-2032)
- 9.5 China
- 9.6 Japan
- 9.7 South Korea
- 9.8 India
- 9.9 Australia
- 9.10 China Taiwan
- 9.11 Southeast Asia
10 South America
- 10.1 South America Software as a Medical Device (SaMD) Market Size (2021-2032)
- 10.2 South America Software as a Medical Device (SaMD) Market Growth Rate by Country: 2021 VS 2025 VS 2032
- 10.3 South America Software as a Medical Device (SaMD) Market Size by Country (2021-2026)
- 10.4 South America Software as a Medical Device (SaMD) Market Size by Country (2027-2032)
- 10.5 Brazil
- 10.6 Argentina
- 10.7 Chile
- 10.8 Colombia
- 10.9 Peru
11 Middle East & Africa
- 11.1 Middle East & Africa Software as a Medical Device (SaMD) Market Size (2021-2032)
- 11.2 Middle East & Africa Software as a Medical Device (SaMD) Market Growth Rate by Country: 2021 VS 2025 VS 2032
- 11.3 Middle East & Africa Software as a Medical Device (SaMD) Market Size by Country (2021-2026)
- 11.4 Middle East & Africa Software as a Medical Device (SaMD) Market Size by Country (2027-2032)
- 11.5 Saudi Arabia
- 11.6 Israel
- 11.7 United Arab Emirates
- 11.8 Turkey
- 11.9 Iran
- 11.10 Egypt
12 Players Profiled
- 12.1 MindMaze
- 12.1.1 MindMaze Company Information
- 12.1.2 MindMaze Business Overview
- 12.1.3 MindMaze Revenue in Software as a Medical Device (SaMD) Business (2021-2026)
- 12.1.4 MindMaze Software as a Medical Device (SaMD) Product Portfolio
- 12.1.5 MindMaze Recent Developments
- 12.2 Medtronic
- 12.2.1 Medtronic Company Information
- 12.2.2 Medtronic Business Overview
- 12.2.3 Medtronic Revenue in Software as a Medical Device (SaMD) Business (2021-2026)
- 12.2.4 Medtronic Software as a Medical Device (SaMD) Product Portfolio
- 12.2.5 Medtronic Recent Developments
- 12.3 Viz.AI.
- 12.3.1 Viz.AI. Company Information
- 12.3.2 Viz.AI. Business Overview
- 12.3.3 Viz.AI. Revenue in Software as a Medical Device (SaMD) Business (2021-2026)
- 12.3.4 Viz.AI. Software as a Medical Device (SaMD) Product Portfolio
- 12.3.5 Viz.AI. Recent Developments
- 12.4 Siemens Healthcare
- 12.4.1 Siemens Healthcare Company Information
- 12.4.2 Siemens Healthcare Business Overview
- 12.4.3 Siemens Healthcare Revenue in Software as a Medical Device (SaMD) Business (2021-2026)
- 12.4.4 Siemens Healthcare Software as a Medical Device (SaMD) Product Portfolio
- 12.4.5 Siemens Healthcare Recent Developments
- 12.5 iSchemaView
- 12.5.1 iSchemaView Company Information
- 12.5.2 iSchemaView Business Overview
- 12.5.3 iSchemaView Revenue in Software as a Medical Device (SaMD) Business (2021-2026)
- 12.5.4 iSchemaView Software as a Medical Device (SaMD) Product Portfolio
- 12.5.5 iSchemaView Recent Developments
- 12.6 Arterys
- 12.6.1 Arterys Company Information
- 12.6.2 Arterys Business Overview
- 12.6.3 Arterys Revenue in Software as a Medical Device (SaMD) Business (2021-2026)
- 12.6.4 Arterys Software as a Medical Device (SaMD) Product Portfolio
- 12.6.5 Arterys Recent Developments
- 12.7 Adherium
- 12.7.1 Adherium Company Information
- 12.7.2 Adherium Business Overview
- 12.7.3 Adherium Revenue in Software as a Medical Device (SaMD) Business (2021-2026)
- 12.7.4 Adherium Software as a Medical Device (SaMD) Product Portfolio
- 12.7.5 Adherium Recent Developments
- 12.8 Digital Diagnostics
- 12.8.1 Digital Diagnostics Company Information
- 12.8.2 Digital Diagnostics Business Overview
- 12.8.3 Digital Diagnostics Revenue in Software as a Medical Device (SaMD) Business (2021-2026)
- 12.8.4 Digital Diagnostics Software as a Medical Device (SaMD) Product Portfolio
- 12.8.5 Digital Diagnostics Recent Developments
- 12.9 Allscripts
- 12.9.1 Allscripts Company Information
- 12.9.2 Allscripts Business Overview
- 12.9.3 Allscripts Revenue in Software as a Medical Device (SaMD) Business (2021-2026)
- 12.9.4 Allscripts Software as a Medical Device (SaMD) Product Portfolio
- 12.9.5 Allscripts Recent Developments
13 Report Conclusion
14 Disclaimer
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