Global Software as a Medical Device (SaMD) Competitive Landscape Professional Research Report 2026
Description
Market Overview
According to DIResearch＇s in-depth investigation and research, the global Software as a Medical Device (SaMD) market size will reach 2,870.16 Million USD in 2026 and is projected to reach 14,398.85 Million USD by 2033, with a CAGR of 25.91% (2026-2033). Notably, the China Software as a Medical Device (SaMD) market has changed rapidly in the past few years. By 2026, China＇s market size is expected to be Million USD, representing approximately % of the global market share.
Research Summary
Software as a Medical Device (SaMD) refers to software intended to be used for medical purposes without being part of a hardware medical device. SaMD operates independently or in conjunction with other devices, including mobile apps, and is designed to provide clinical information, diagnostic advice, or medical decision support. It can analyze data input from medical devices or patient data to provide information critical for healthcare decisions. SaMD varies widely in complexity, ranging from simple mobile apps for tracking fitness metrics to sophisticated algorithms for diagnosing diseases or recommending treatment plans. Regulatory bodies such as the FDA in the United States and the European Commission＇s Medical Device Regulation (MDR) classify SaMD based on risk and functionality, ensuring compliance with safety, efficacy, and privacy standards. As the field of digital health continues to evolve, SaMD plays an increasingly significant role in enhancing healthcare delivery, patient outcomes, and clinical decision-making.
The major global suppliers of Software as a Medical Device (SaMD) include MindMaze, Medtronic, Viz.AI., Siemens Healthcare, iSchemaView, Adherium, Arterys, Digital Diagnostics, Allscripts, etc. The global players competition landscape in this report is divided into three tiers. The first tier comprises global leading enterprises that command a substantial market share, hold a dominant industry position, possess strong competitiveness and influence, and generate significant revenue. The second tier includes companies with a notable market presence and reputation; these firms actively follow industry leaders in product, service, or technological innovation and maintain a moderate revenue scale. The third tier consists of smaller companies with limited market share and lower brand recognition, primarily focused on local markets and generating comparatively lower revenue.
This report studies the market size, price trends and future development prospects of Software as a Medical Device (SaMD). Focus on analysing the market share, product portfolio, prices, revenue and gross profit margin of global major suppliers, as well as the market status and trends of different product types and applications in the global Software as a Medical Device (SaMD) market. The report data covers historical data from 2021 to 2025, based year in 2026 and forecast data from 2027 to 2033.
The regions and countries in the report include North America, Europe, China, APAC (excl. China), Latin America and Middle East and Africa, covering the Software as a Medical Device (SaMD) market conditions and future development trends of key regions and countries, combined with industry-related policies and the latest technological developments, analyze the development characteristics of Software as a Medical Device (SaMD) industries in various regions and countries, help companies understand the development characteristics of each region, help companies formulate business strategies, and achieve the ultimate goal of the company's global development strategy.
The data sources of this report mainly include the National Bureau of Statistics, customs databases, industry associations, corporate financial reports, third-party databases, etc. Among them, macroeconomic data mainly comes from the National Bureau of Statistics, International Economic Research Organization; industry statistical data mainly come from industry associations; company data mainly comes from interviews, public information collection, third-party reliable databases, and price data mainly comes from various markets monitoring database.
Global Key Suppliers of Software as a Medical Device (SaMD) Include:
MindMaze
Medtronic
Viz.AI.
Siemens Healthcare
iSchemaView
Adherium
Arterys
Digital Diagnostics
Allscripts
Software as a Medical Device (SaMD) Product Segment Include:
Cloud-based
On Premise
Software as a Medical Device (SaMD) Product Application Include:
Screening and Diagnosis
Monitoring and Alerting
Chronic Disease Management
Other
Chapter Scope
Chapter 1: Product Research Range, Product Types and Applications, Market Overview, Market Situation and Trends
Chapter 2: Global Software as a Medical Device (SaMD) Industry PESTEL Analysis
Chapter 3: Global Software as a Medical Device (SaMD) Industry Porter’s Five Forces Analysis
Chapter 4: Global Software as a Medical Device (SaMD) Major Regional Market Size and Forecast Analysis
Chapter 5: Global Software as a Medical Device (SaMD) Market Size and Forecast by Type and Application Analysis
Chapter 6: North America Passenger Software as a Medical Device (SaMD) Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)
Chapter 7: Europe Software as a Medical Device (SaMD) Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)
Chapter 8: China Software as a Medical Device (SaMD) Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)
Chapter 9: APAC (Excl. China) Software as a Medical Device (SaMD) Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)
Chapter 10: Latin America Software as a Medical Device (SaMD) Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)
Chapter 11: Middle East and Africa Software as a Medical Device (SaMD) Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)
Chapter 12: Global Software as a Medical Device (SaMD) Competitive Analysis of Key Suppliers (Revenue, Market Share, Regional Distribution and Industry Concentration)
Chapter 13: Key Company Profiles (Product Portfolio, Revenue and Gross Margin)
Chapter 14: Industrial Chain Analysis, Include Raw Material Suppliers, Distributors and Customers
Chapter 15: Research Findings and Conclusion
Chapter 16: Methodology and Data Sources
According to DIResearch＇s in-depth investigation and research, the global Software as a Medical Device (SaMD) market size will reach 2,870.16 Million USD in 2026 and is projected to reach 14,398.85 Million USD by 2033, with a CAGR of 25.91% (2026-2033). Notably, the China Software as a Medical Device (SaMD) market has changed rapidly in the past few years. By 2026, China＇s market size is expected to be Million USD, representing approximately % of the global market share.
Research Summary
Software as a Medical Device (SaMD) refers to software intended to be used for medical purposes without being part of a hardware medical device. SaMD operates independently or in conjunction with other devices, including mobile apps, and is designed to provide clinical information, diagnostic advice, or medical decision support. It can analyze data input from medical devices or patient data to provide information critical for healthcare decisions. SaMD varies widely in complexity, ranging from simple mobile apps for tracking fitness metrics to sophisticated algorithms for diagnosing diseases or recommending treatment plans. Regulatory bodies such as the FDA in the United States and the European Commission＇s Medical Device Regulation (MDR) classify SaMD based on risk and functionality, ensuring compliance with safety, efficacy, and privacy standards. As the field of digital health continues to evolve, SaMD plays an increasingly significant role in enhancing healthcare delivery, patient outcomes, and clinical decision-making.
The major global suppliers of Software as a Medical Device (SaMD) include MindMaze, Medtronic, Viz.AI., Siemens Healthcare, iSchemaView, Adherium, Arterys, Digital Diagnostics, Allscripts, etc. The global players competition landscape in this report is divided into three tiers. The first tier comprises global leading enterprises that command a substantial market share, hold a dominant industry position, possess strong competitiveness and influence, and generate significant revenue. The second tier includes companies with a notable market presence and reputation; these firms actively follow industry leaders in product, service, or technological innovation and maintain a moderate revenue scale. The third tier consists of smaller companies with limited market share and lower brand recognition, primarily focused on local markets and generating comparatively lower revenue.
This report studies the market size, price trends and future development prospects of Software as a Medical Device (SaMD). Focus on analysing the market share, product portfolio, prices, revenue and gross profit margin of global major suppliers, as well as the market status and trends of different product types and applications in the global Software as a Medical Device (SaMD) market. The report data covers historical data from 2021 to 2025, based year in 2026 and forecast data from 2027 to 2033.
The regions and countries in the report include North America, Europe, China, APAC (excl. China), Latin America and Middle East and Africa, covering the Software as a Medical Device (SaMD) market conditions and future development trends of key regions and countries, combined with industry-related policies and the latest technological developments, analyze the development characteristics of Software as a Medical Device (SaMD) industries in various regions and countries, help companies understand the development characteristics of each region, help companies formulate business strategies, and achieve the ultimate goal of the company's global development strategy.
The data sources of this report mainly include the National Bureau of Statistics, customs databases, industry associations, corporate financial reports, third-party databases, etc. Among them, macroeconomic data mainly comes from the National Bureau of Statistics, International Economic Research Organization; industry statistical data mainly come from industry associations; company data mainly comes from interviews, public information collection, third-party reliable databases, and price data mainly comes from various markets monitoring database.
Global Key Suppliers of Software as a Medical Device (SaMD) Include:
MindMaze
Medtronic
Viz.AI.
Siemens Healthcare
iSchemaView
Adherium
Arterys
Digital Diagnostics
Allscripts
Software as a Medical Device (SaMD) Product Segment Include:
Cloud-based
On Premise
Software as a Medical Device (SaMD) Product Application Include:
Screening and Diagnosis
Monitoring and Alerting
Chronic Disease Management
Other
Chapter Scope
Chapter 1: Product Research Range, Product Types and Applications, Market Overview, Market Situation and Trends
Chapter 2: Global Software as a Medical Device (SaMD) Industry PESTEL Analysis
Chapter 3: Global Software as a Medical Device (SaMD) Industry Porter’s Five Forces Analysis
Chapter 4: Global Software as a Medical Device (SaMD) Major Regional Market Size and Forecast Analysis
Chapter 5: Global Software as a Medical Device (SaMD) Market Size and Forecast by Type and Application Analysis
Chapter 6: North America Passenger Software as a Medical Device (SaMD) Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)
Chapter 7: Europe Software as a Medical Device (SaMD) Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)
Chapter 8: China Software as a Medical Device (SaMD) Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)
Chapter 9: APAC (Excl. China) Software as a Medical Device (SaMD) Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)
Chapter 10: Latin America Software as a Medical Device (SaMD) Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)
Chapter 11: Middle East and Africa Software as a Medical Device (SaMD) Competitive Analysis (Market Size, Key Players and Market Share, Product Type and Application Segment Analysis, Countries Analysis)
Chapter 12: Global Software as a Medical Device (SaMD) Competitive Analysis of Key Suppliers (Revenue, Market Share, Regional Distribution and Industry Concentration)
Chapter 13: Key Company Profiles (Product Portfolio, Revenue and Gross Margin)
Chapter 14: Industrial Chain Analysis, Include Raw Material Suppliers, Distributors and Customers
Chapter 15: Research Findings and Conclusion
Chapter 16: Methodology and Data Sources
Table of Contents
170 Pages
- 1 Software as a Medical Device (SaMD) Market Overview
- 1.1 Product Definition and Statistical Scope
- 1.2 Software as a Medical Device (SaMD) Product by Type
- 1.2.1 Cloud-based
- 1.2.2 On Premise
- 1.3 Software as a Medical Device (SaMD) Product by Application
- 1.3.1 Screening and Diagnosis
- 1.3.2 Monitoring and Alerting
- 1.3.3 Chronic Disease Management
- 1.3.4 Other
- 1.4 Global Software as a Medical Device (SaMD) Market Size Analysis (2021-2033)
- 1.5 Software as a Medical Device (SaMD) Market Development Status and Trends
- 1.5.1 Software as a Medical Device (SaMD) Industry Development Status Analysis
- 1.5.2 Software as a Medical Device (SaMD) Industry Development Trends Analysis
- 2 Software as a Medical Device (SaMD) Market PESTEL Analysis
- 2.1 Political Factors Analysis
- 2.2 Economic Factors Analysis
- 2.3 Social Factors Analysis
- 2.4 Technological Factors Analysis
- 2.5 Environmental Factors Analysis
- 2.6 Legal Factors Analysis
- 3 Software as a Medical Device (SaMD) Market Porter's Five Forces Analysis
- 3.1 Competitive Rivalry
- 3.2 Threat of New Entrants
- 3.3 Bargaining Power of Suppliers
- 3.4 Bargaining Power of Buyers
- 3.5 Threat of Substitutes
- 4 Global Software as a Medical Device (SaMD) Market Analysis by Regions
- 4.1 Software as a Medical Device (SaMD) Overall Market: 2025 VS 2026 VS 2033
- 4.2 Global Software as a Medical Device (SaMD) Revenue and Forecast Analysis (2021-2033)
- 4.2.1 Global Software as a Medical Device (SaMD) Revenue and Market Share by Region (2021-2026)
- 4.2.2 Global Software as a Medical Device (SaMD) Revenue and Market Share Forecast by Region (2027-2033)
- 5 Global Software as a Medical Device (SaMD) Market Size by Type and Application
- 5.1 Global Software as a Medical Device (SaMD) Market Size by Type (2021-2033)
- 5.2 Global Software as a Medical Device (SaMD) Market Size by Application (2021-2033)
- 6 North America
- 6.1 North America Software as a Medical Device (SaMD) Market Size and Growth Rate Analysis (2021-2033)
- 6.2 North America Key Suppliers Analysis
- 6.3 North America Software as a Medical Device (SaMD) Market Size by Type
- 6.4 North America Software as a Medical Device (SaMD) Market Size by Application
- 6.5 North America Software as a Medical Device (SaMD) Market Size by Country
- 6.5.1 US
- 6.5.2 Canada
- 7 Europe
- 7.1 Europe Software as a Medical Device (SaMD) Market Size and Growth Rate Analysis (2021-2033)
- 7.2 Europe Key Suppliers Analysis
- 7.3 Europe Software as a Medical Device (SaMD) Market Size by Type
- 7.4 Europe Software as a Medical Device (SaMD) Market Size by Application
- 7.5 Europe Software as a Medical Device (SaMD) Market Size by Country
- 7.5.1 Germany
- 7.5.2 France
- 7.5.3 United Kingdom
- 7.5.4 Italy
- 7.5.5 Spain
- 7.5.6 Benelux
- 8 China
- 8.1 China Software as a Medical Device (SaMD) Market Size and Growth Rate Analysis (2021-2033)
- 8.2 China Key Suppliers Analysis
- 8.3 China Software as a Medical Device (SaMD) Market Size by Type
- 8.4 China Software as a Medical Device (SaMD) Market Size by Application
- 9 APAC (excl. China)
- 9.1 APAC (excl. China) Software as a Medical Device (SaMD) Market Size and Growth Rate Analysis (2021-2033)
- 9.2 APAC (excl. China) Key Suppliers Analysis
- 9.3 APAC (excl. China) Software as a Medical Device (SaMD) Market Size by Type
- 9.4 APAC (excl. China) Software as a Medical Device (SaMD) Market Size by Application
- 9.5 APAC (excl. China) Software as a Medical Device (SaMD) Market Size by Country
- 9.5.1 Japan
- 9.5.2 South Korea
- 9.5.3 India
- 9.5.4 Australia
- 9.5.5 Southeast Asia
- 10 Latin America
- 10.1 Latin America Software as a Medical Device (SaMD) Market Size and Growth Rate Analysis (2021-2033)
- 10.2 Latin America Key Suppliers Analysis
- 10.3 Latin America Software as a Medical Device (SaMD) Market Size by Type
- 10.4 Latin America Software as a Medical Device (SaMD) Market Size by Application
- 10.5 Latin America Software as a Medical Device (SaMD) Market Size by Country
- 10.5.1 Mexico
- 10.5.2 Brazil
- 11 Middle East & Africa
- 11.1 Middle East & Africa Software as a Medical Device (SaMD) Market Size and Growth Rate Analysis (2021-2033)
- 11.2 Middle East & Africa Key Suppliers Analysis
- 11.3 Middle East & Africa Software as a Medical Device (SaMD) Market Size by Type
- 11.4 Middle East & Africa Software as a Medical Device (SaMD) Market Size by Application
- 11.5 Middle East & Africa Software as a Medical Device (SaMD) Market Size by Country
- 11.5.1 Saudi Arabia
- 11.5.2 South Africa
- 12 Competition by Suppliers
- 12.1 Global Software as a Medical Device (SaMD) Market Revenue by Key Suppliers (2021-2033)
- 12.2 Software as a Medical Device (SaMD) Competitive Landscape Analysis and Market Dynamic
- 12.2.1 Software as a Medical Device (SaMD) Competitive Landscape Analysis
- 12.2.2 Global Key Suppliers Headquarter Location and Key Area Sales
- 12.2.3 Market Dynamic
- 13 Key Companies Analysis
- 13.1 MindMaze
- 13.1.1 MindMaze Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
- 13.1.2 MindMaze Software as a Medical Device (SaMD) Product Portfolio
- 13.1.3 MindMaze Software as a Medical Device (SaMD) Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2026)
- 13.2 Medtronic
- 13.2.1 Medtronic Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
- 13.2.2 Medtronic Software as a Medical Device (SaMD) Product Portfolio
- 13.2.3 Medtronic Software as a Medical Device (SaMD) Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2026)
- 13.3 Viz.AI.
- 13.3.1 Viz.AI. Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
- 13.3.2 Viz.AI. Software as a Medical Device (SaMD) Product Portfolio
- 13.3.3 Viz.AI. Software as a Medical Device (SaMD) Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2026)
- 13.4 Siemens Healthcare
- 13.4.1 Siemens Healthcare Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
- 13.4.2 Siemens Healthcare Software as a Medical Device (SaMD) Product Portfolio
- 13.4.3 Siemens Healthcare Software as a Medical Device (SaMD) Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2026)
- 13.5 iSchemaView
- 13.5.1 iSchemaView Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
- 13.5.2 iSchemaView Software as a Medical Device (SaMD) Product Portfolio
- 13.5.3 iSchemaView Software as a Medical Device (SaMD) Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2026)
- 13.6 Adherium
- 13.6.1 Adherium Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
- 13.6.2 Adherium Software as a Medical Device (SaMD) Product Portfolio
- 13.6.3 Adherium Software as a Medical Device (SaMD) Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2026)
- 13.7 Arterys
- 13.7.1 Arterys Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
- 13.7.2 Arterys Software as a Medical Device (SaMD) Product Portfolio
- 13.7.3 Arterys Software as a Medical Device (SaMD) Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2026)
- 13.8 Digital Diagnostics
- 13.8.1 Digital Diagnostics Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
- 13.8.2 Digital Diagnostics Software as a Medical Device (SaMD) Product Portfolio
- 13.8.3 Digital Diagnostics Software as a Medical Device (SaMD) Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2026)
- 13.9 Allscripts
- 13.9.1 Allscripts Basic Company Profile (Employees, Areas Service, Competitors and Contact Information)
- 13.9.2 Allscripts Software as a Medical Device (SaMD) Product Portfolio
- 13.9.3 Allscripts Software as a Medical Device (SaMD) Market Data Analysis (Revenue, Gross Margin and Market Share) (2021-2026)
- 14 Industry Chain Analysis
- 14.1 Software as a Medical Device (SaMD) Industry Chain Analysis
- 14.2 Software as a Medical Device (SaMD) Typical Downstream Customers
- 14.3 Software as a Medical Device (SaMD) Sales Channel Analysis
- 15 Research Findings and Conclusion
- 16 Methodology and Data Source
- 16.1 Methodology/Research Approach
- 16.2 Research Scope
- 16.3 Benchmarks and Assumptions
- 16.4 Date Source
- 16.4.1 Primary Sources
- 16.4.2 Secondary Sources
- 16.5 Data Cross Validation
- 16.6 Disclaimer
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