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.
According to DIResearch's in-depth investigation and research, the global Software as a Medical Device (SaMD) market size will reach US$ Million in 2024, and is expected to reach US$ Million in 2030, with a CAGR of % (2025-2030). Among them, the China market has changed rapidly in the past few years. The market size in 2024 will be US$ Million, accounting for approximately % of the world. It is expected to reach US$ Million in 2030, and the global share will reach %.
The major global manufacturers 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 tiers is the global leading enterprise, which occupies a major market share, is in a leading position in the industry, has strong competitiveness and influence, and has a large revenue scale; the second tiers has a certain share and popularity in the market, actively follows the industry leaders in product, service or technological innovation, and has a medium revenue scale; the third tiers has a smaller share in the market, has a lower brand awareness, mainly focuses on the local market, and has a relatively small revenue scale.
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, revenue and gross profit margin of global major manufacturers, 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 2019 to 2023, base year in 2024 and forecast data from 2025 to 2030.
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 Manufacturers 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 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 Manufacturers (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 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 Global Software as a Medical Device (SaMD) Market Size by Type, 2023 VS 2024 VS 2030 1.2.2 Cloud-based 1.2.3 On Premise 1.3 Software as a Medical Device (SaMD) Product by Application 1.3.1 Global Software as a Medical Device (SaMD) Market Size by Application, 2023 VS 2024 VS 2030 1.3.2 Screening and Diagnosis 1.3.3 Monitoring and Alerting 1.3.4 Chronic Disease Management 1.3.5 Other 1.4 Global Software as a Medical Device (SaMD) Market Revenue Analysis (2019-2030) 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: 2023 VS 2024 VS 2030 4.2 Global Software as a Medical Device (SaMD) Revenue and Forecast Analysis (2019-2030) 4.2.1 Global Software as a Medical Device (SaMD) Revenue and Market Share by Region (2019-2024) 4.2.2 Global Software as a Medical Device (SaMD) Revenue Forecast by Region (2025-2030) 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 5.2 Global Software as a Medical Device (SaMD) Market Size by Application 6 North America 6.1 North America Software as a Medical Device (SaMD) Market Size and Growth Rate Analysis (2019-2030) 6.2 North America Key Manufacturers 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 (2019-2030) 7.2 Europe Key Manufacturers 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 (2019-2030) 8.2 China Key Manufacturers 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 (2019-2030) 9.2 APAC (excl. China) Key Manufacturers 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 Indonesia 9.5.6 Vietnam 9.5.7 Malaysia 9.5.8 Thailand 10 Latin America 10.1 Latin America Software as a Medical Device (SaMD) Market Size and Growth Rate Analysis (2019-2030) 10.2 Latin America Key Manufacturers 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 Mecixo 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 (2019-2030) 11.2 Middle East & Africa Key Manufacturers 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 Market Competition by Manufacturers 12.1 Global Software as a Medical Device (SaMD) Market Revenue by Key Manufacturers (2020-2024) 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 Manufacturers Headquarter 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) (2020-2024) 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) (2020-2024) 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) (2020-2024) 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) (2020-2024) 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) (2020-2024) 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) (2020-2024) 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) (2020-2024) 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) (2020-2024) 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) (2020-2024) 14 Industry Chain Analysis 14.1 Software as a Medical Device (SaMD) Industry Chain Analysis 14.2 Software as a Medical Device (SaMD) Industry Raw Material and Suppliers Analysis 14.2.1 Upstream Key Raw Material Supply Analysis 14.2.2 Raw Material Suppliers and Contact Information 14.3 Software as a Medical Device (SaMD) Typical Downstream Customers 14.4 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
Publisher: DIResearch
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