APO RESEARCH · REPORT
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 Growth & Trends
Global Software as a Medical Device (SaMD) Industry Growth and Trends Forecast to 2032
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 APO Research, the global Software as a Medical Device (SaMD) market was valued at US$ million in 2026 and is projected to reach US$ million by 2032, implying a CAGR of xx% over 2026-2032.
Report Scope
Read the full market overview
This report provides a structured, data-driven view of the global Software as a Medical Device (SaMD) market, combining harmonized quantitative metrics with targeted qualitative insight to support business and growth strategy, market positioning, and capital allocation.
The Software as a Medical Device (SaMD) market size, estimates, and forecasts are presented in terms of revenue (US$ million), with 2025 as the base year and historical and forecast data for 2021-2032. The report segments the global Software as a Medical Device (SaMD) market by Type, Application, region/country, and company, provides regional market sizes at the segment level, profiles the competitive landscape and key players and their market ranks, and reviews technology trends and new product developments relevant to Software as a Medical Device (SaMD).
Key Companies & Market Share Insights
This section analyzes the strategies and performance of leading companies in the global Software as a Medical Device (SaMD) market, including portfolio focus, innovation and product development, mergers and acquisitions, collaborations, and geographic expansion used to sustain or enhance competitive positions. It also summarizes recent corporate developments and key financial indicators and provides global revenue and gross margin data by manufacturer for 2021-2026, enabling benchmarking of scale, profitability, and market share and supporting assessment of market concentration through indicators such as CR5 and CR10.
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
Russia
Spain
Netherlands
Switzerland
Sweden
Poland
Asia-Pacific
China
Japan
South Korea
India
Australia
Taiwan
Southeast Asia
South America
Brazil
Argentina
Chile
Middle East & Africa
Egypt
South Africa
Israel
Türkiye
GCC Countries
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 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: Introduces the report scope of the report, executive summary of global and regional market size and CAGR for the history and forecast period (2021-2025, 2026-2031). 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 2: Provides the analysis of various market segments by type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter 3: Provides the analysis of various market segments by 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 4: Introduces the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by manufacturers in the industry, and the analysis of relevant policies in the industry.
Chapter 5: Detailed analysis of Software as a Medical Device (SaMD) companies' competitive landscape, revenue, market share and ranking, latest development plan, merger, and acquisition information, etc.
Chapter 6: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product introduction, revenue, recent development, etc.
Chapter 7, 8, 9, 10 and 11: North America, Europe, Asia Pacific, South America, Middle East & Africa, revenue by country.
Chapter 12: Concluding Insights 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 Market Overview
- 1.1 Product Definition
- 1.2 Global Market Growth Prospects
- 1.3 Global Software as a Medical Device (SaMD) Market Size Overview by Region 2021 VS 2025 VS 2032
- 1.4 Global Software as a Medical Device (SaMD) Market Size by Region (2021-2032)
- 1.4.1 Global Software as a Medical Device (SaMD) Market Size by Region (2021-2026)
- 1.4.2 Global Software as a Medical Device (SaMD) Market Size by Region (2027-2032)
- 1.5 Key Regions Software as a Medical Device (SaMD) Market Size (2021-2032)
- 1.5.1 North America Software as a Medical Device (SaMD) Market Size Growth Rate (2021-2032)
- 1.5.2 Europe Software as a Medical Device (SaMD) Market Size Growth Rate (2021-2032)
- 1.5.3 Asia-Pacific Software as a Medical Device (SaMD) Market Size Growth Rate (2021-2032)
- 1.5.4 South America Software as a Medical Device (SaMD) Market Size Growth Rate (2021-2032)
- 1.5.5 Middle East & Africa Software as a Medical Device (SaMD) Market Size Growth Rate (2021-2032)
2 Software as a Medical Device (SaMD) Market by Type
- 2.1 Type Introduction
- 2.1.1 Cloud-based
- 2.1.2 On Premise
- 2.2 Global Software as a Medical Device (SaMD) Market Size by Type
- 2.2.1 Global Software as a Medical Device (SaMD) Market Size Overview by Type (2021-2032)
- 2.2.2 Global Software as a Medical Device (SaMD) Historic Market Size Review by Type (2021-2026)
- 2.2.3 Global Software as a Medical Device (SaMD) Market Size Forecasted by Type (2027-2032)
- 2.3 Global Software as a Medical Device (SaMD) Market Size by Regions
- 2.3.1 North America Software as a Medical Device (SaMD) Market Size Breakdown by Type (2021-2026)
- 2.3.2 Europe Software as a Medical Device (SaMD) Market Size Breakdown by Type (2021-2026)
- 2.3.3 Asia-Pacific Software as a Medical Device (SaMD) Market Size Breakdown by Type (2021-2026)
- 2.3.4 South America Software as a Medical Device (SaMD) Market Size Breakdown by Type (2021-2026)
- 2.3.5 Middle East and Africa Software as a Medical Device (SaMD) Market Size Breakdown by Type (2021-2026)
3 Software as a Medical Device (SaMD) Market by Application
- 3.1 Type Introduction
- 3.1.1 Screening and Diagnosis
- 3.1.2 Monitoring and Alerting
- 3.1.3 Chronic Disease Management
- 3.1.4 Other
- 3.2 Global Software as a Medical Device (SaMD) Market Size by Application
- 3.2.1 Global Software as a Medical Device (SaMD) Market Size Overview by Application (2021-2032)
- 3.2.2 Global Software as a Medical Device (SaMD) Historic Market Size Review by Application (2021-2026)
- 3.2.3 Global Software as a Medical Device (SaMD) Market Size Forecasted by Application (2027-2032)
- 3.3 Global Software as a Medical Device (SaMD) Market Size by Regions
- 3.3.1 North America Software as a Medical Device (SaMD) Market Size Breakdown by Application (2021-2026)
- 3.3.2 Europe Software as a Medical Device (SaMD) Market Size Breakdown by Application (2021-2026)
- 3.3.3 Asia-Pacific Software as a Medical Device (SaMD) Market Size Breakdown by Application (2021-2026)
- 3.3.4 South America Software as a Medical Device (SaMD) Market Size Breakdown by Application (2021-2026)
- 3.3.5 Middle East and Africa Software as a Medical Device (SaMD) Market Size Breakdown by Application (2021-2026)
4 Global Market Dynamics
- 4.1 Software as a Medical Device (SaMD) Industry Trends
- 4.2 Software as a Medical Device (SaMD) Industry Drivers
- 4.3 Software as a Medical Device (SaMD) Industry Opportunities and Challenges
- 4.4 Software as a Medical Device (SaMD) Industry Restraints
5 Competitive Insights by Company
- 5.1 Global Top Players by Software as a Medical Device (SaMD) Revenue (2021-2026)
- 5.2 Global Software as a Medical Device (SaMD) Industry Company Ranking, 2024 VS 2025 VS 2026
- 5.3 Global Software as a Medical Device (SaMD) Key Company Headquarters & Area Served
- 5.4 Global Software as a Medical Device (SaMD) Company, Product Type & Application
- 5.5 Global Software as a Medical Device (SaMD) Company Commercialization Time
- 5.6 Market Competitive Analysis
- 5.6.1 Global Software as a Medical Device (SaMD) Market CR5 and HHI
- 5.6.2 Global Top 5 and 10 Software as a Medical Device (SaMD) Players Market Share by Revenue in 2025
- 5.6.3 2025 Software as a Medical Device (SaMD) Tier 1, Tier 2, and Tier 3
6 Company Profiles
- 6.1 MindMaze
- 6.1.1 MindMaze Company Information
- 6.1.2 MindMaze Business Overview
- 6.1.3 MindMaze Software as a Medical Device (SaMD) Revenue, Global Share and Gross Margin (2021-2026)
- 6.1.4 MindMaze Software as a Medical Device (SaMD) Product Portfolio
- 6.1.5 MindMaze Recent Developments
- 6.2 Medtronic
- 6.2.1 Medtronic Company Information
- 6.2.2 Medtronic Business Overview
- 6.2.3 Medtronic Software as a Medical Device (SaMD) Revenue, Global Share and Gross Margin (2021-2026)
- 6.2.4 Medtronic Software as a Medical Device (SaMD) Product Portfolio
- 6.2.5 Medtronic Recent Developments
- 6.3 Viz.AI.
- 6.3.1 Viz.AI. Company Information
- 6.3.2 Viz.AI. Business Overview
- 6.3.3 Viz.AI. Software as a Medical Device (SaMD) Revenue, Global Share and Gross Margin (2021-2026)
- 6.3.4 Viz.AI. Software as a Medical Device (SaMD) Product Portfolio
- 6.3.5 Viz.AI. Recent Developments
- 6.4 Siemens Healthcare
- 6.4.1 Siemens Healthcare Company Information
- 6.4.2 Siemens Healthcare Business Overview
- 6.4.3 Siemens Healthcare Software as a Medical Device (SaMD) Revenue, Global Share and Gross Margin (2021-2026)
- 6.4.4 Siemens Healthcare Software as a Medical Device (SaMD) Product Portfolio
- 6.4.5 Siemens Healthcare Recent Developments
- 6.5 iSchemaView
- 6.5.1 iSchemaView Company Information
- 6.5.2 iSchemaView Business Overview
- 6.5.3 iSchemaView Software as a Medical Device (SaMD) Revenue, Global Share and Gross Margin (2021-2026)
- 6.5.4 iSchemaView Software as a Medical Device (SaMD) Product Portfolio
- 6.5.5 iSchemaView Recent Developments
- 6.6 Arterys
- 6.6.1 Arterys Company Information
- 6.6.2 Arterys Business Overview
- 6.6.3 Arterys Software as a Medical Device (SaMD) Revenue, Global Share and Gross Margin (2021-2026)
- 6.6.4 Arterys Software as a Medical Device (SaMD) Product Portfolio
- 6.6.5 Arterys Recent Developments
- 6.7 Adherium
- 6.7.1 Adherium Company Information
- 6.7.2 Adherium Business Overview
- 6.7.3 Adherium Software as a Medical Device (SaMD) Revenue, Global Share and Gross Margin (2021-2026)
- 6.7.4 Adherium Software as a Medical Device (SaMD) Product Portfolio
- 6.7.5 Adherium Recent Developments
- 6.8 Digital Diagnostics
- 6.8.1 Digital Diagnostics Company Information
- 6.8.2 Digital Diagnostics Business Overview
- 6.8.3 Digital Diagnostics Software as a Medical Device (SaMD) Revenue, Global Share and Gross Margin (2021-2026)
- 6.8.4 Digital Diagnostics Software as a Medical Device (SaMD) Product Portfolio
- 6.8.5 Digital Diagnostics Recent Developments
- 6.9 Allscripts
- 6.9.1 Allscripts Company Information
- 6.9.2 Allscripts Business Overview
- 6.9.3 Allscripts Software as a Medical Device (SaMD) Revenue, Global Share and Gross Margin (2021-2026)
- 6.9.4 Allscripts Software as a Medical Device (SaMD) Product Portfolio
- 6.9.5 Allscripts Recent Developments
7 North America
- 7.1 North America Software as a Medical Device (SaMD) Market Size Growth Rate (CAGR) by Country: 2021 VS 2025 VS 2032
- 7.2 North America Software as a Medical Device (SaMD) Market Size by Country (2021-2026)
- 7.3 North America Software as a Medical Device (SaMD) Market Size Forecast by Country (2027-2032)
8 Europe
- 8.1 Europe Software as a Medical Device (SaMD) Market Size Growth Rate (CAGR) by Country: 2021 VS 2025 VS 2032
- 8.2 Europe Software as a Medical Device (SaMD) Market Size by Country (2021-2026)
- 8.3 Europe Software as a Medical Device (SaMD) Market Size Forecast by Country (2027-2032)
9 Asia-Pacific
- 9.1 Asia-Pacific Software as a Medical Device (SaMD) Market Size Growth Rate (CAGR) by Country: 2021 VS 2025 VS 2032
- 9.2 Asia-Pacific Software as a Medical Device (SaMD) Market Size by Country (2021-2026)
- 9.3 Asia-Pacific Software as a Medical Device (SaMD) Market Size Forecast by Country (2027-2032)
10 South America
- 10.1 South America Software as a Medical Device (SaMD) Market Size Growth Rate (CAGR) by Country: 2021 VS 2025 VS 2032
- 10.2 South America Software as a Medical Device (SaMD) Market Size by Country (2021-2026)
- 10.3 South America Software as a Medical Device (SaMD) Market Size Forecast by Country (2027-2032)
11 Middle East & Africa
- 11.1 Middle East & Africa Software as a Medical Device (SaMD) Market Size Growth Rate (CAGR) by Country: 2021 VS 2025 VS 2032
- 11.2 Middle East & Africa Software as a Medical Device (SaMD) Market Size by Country (2021-2026)
- 11.3 Middle East & Africa Software as a Medical Device (SaMD) Market Size Forecast by Country (2027-2032)
12 Concluding Insights
13 Appendix
- 13.1 Reasons for Doing This Study
- 13.2 Research Methodology
- 13.3 Research Process
- 13.4 Authors List of This Report
- 13.5 Data Source
- 13.5.1 Secondary Sources
- 13.5.2 Primary Sources
GET THE RESEARCH
Choose your license.
Choose who needs access.
All options are for this report and research series.
PDF by email within 3–5 working days after payment confirmation.
Talk to an analyst