Global Software as a Medical Device (SaMD) Market by Size, by Type, by Application, by Region, History and Forecast 2020-2031

Summary

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 is projected to grow from US$ million in 2025 to US$ million by 2031, at a Compound Annual Growth Rate (CAGR) of % during the forecast period.

The US & Canada market for Software as a Medical Device (SaMD) is estimated to increase from $ million in 2025 to reach $ million by 2031, at a CAGR of % during the forecast period of 2025 through 2031.

Asia-Pacific market for Software as a Medical Device (SaMD) is estimated to increase from $ million in 2025 to reach $ million by 2031, at a CAGR of % during the forecast period of 2025 through 2031.

The China market for Software as a Medical Device (SaMD) is estimated to increase from $ million in 2025 to reach $ million by 2031, at a CAGR of % during the forecast period of 2025 through 2031.

Europe market for Software as a Medical Device (SaMD) is estimated to increase from $ million in 2025 to reach $ million by 2031, at a CAGR of % during the forecast period of 2025 through 2031.

The major global companies of Software as a Medical Device (SaMD) include MindMaze, Medtronic, Viz.AI., Siemens Healthcare, iSchemaView, Arterys, Adherium, Digital Diagnostics and Allscripts, etc. In 2024, the world's top three vendors accounted for approximately % of the revenue.

Report Includes


This report presents an overview of global market for Software as a Medical Device (SaMD), market size. Analyses of the global market trends, with historic market revenue data for 2020 - 2024, estimates for 2025, and projections of CAGR through 2031.

This report researches the key producers of Software as a Medical Device (SaMD), also provides the revenue of main regions and countries. Of the upcoming market potential for Software as a Medical Device (SaMD), and key regions or countries of focus to forecast this market into various segments and sub-segments. Country specific data and market value analysis for the U.S., Canada, Mexico, Brazil, China, Japan, South Korea, Southeast Asia, India, Germany, the U.K., Italy, Middle East, Africa, and Other Countries.

This report focuses on the Software as a Medical Device (SaMD) revenue, market share and industry ranking of main manufacturers, data from 2020 to 2025. Identification of the major stakeholders in the global Software as a Medical Device (SaMD) market, and analysis of their competitive landscape and market positioning based on recent developments and segmental revenues. This report will help stakeholders to understand the competitive landscape and gain more insights and position their businesses and market strategies in a better way.

This report analyzes the segments data by Type and by Application, revenue, and growth rate, from 2020 to 2031. Evaluation and forecast the market size for Software as a Medical Device (SaMD) revenue, projected growth trends, production technology, application and end-user industry.


Software as a Medical Device (SaMD) Segment 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

Study Objectives

1. To analyze and research the global status and future forecast, involving, production, value, consumption, growth rate (CAGR), market share, historical and forecast.
2. To present the key manufacturers, capacity, production, revenue, market share, and Recent Developments.
3. To split the breakdown data by regions, type, manufacturers, and Application.
4. To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints, and risks.
5. To identify significant trends, drivers, influence factors in global and regions.
6. To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market.

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: 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. Revenue of Software as a Medical Device (SaMD) in global and regional level. 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. 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: Analysis key trends, drivers, challenges, and opportunities within the global Software as a Medical Device (SaMD) industry.
Chapter 3: Detailed analysis of Software as a Medical Device (SaMD) companies' competitive landscape, revenue, market share and industry ranking, latest development plan, merger, and acquisition information, etc.
Chapter 4: Provides the analysis of various market segments by type, covering the revenue, and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter 5: Provides the analysis of various market segments by application, covering the revenue, and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter 6: Provides profiles of key companies, introducing the basic situation of the main companies in the market in detail, including product descriptions and specifications, Software as a Medical Device (SaMD)revenue, gross margin, and recent development, etc.
Chapter 7: North America (US & Canada) by type, by application and by country, revenue for each segment.
Chapter 8: Europe by type, by application and by country, revenue for each segment.
Chapter 9: China by type, and by application, revenue for each segment.
Chapter 10: Asia (excluding China) by type, by application and by region, revenue for each segment.
Chapter 11: South America, Middle East & Africa by type, by application and by country, revenue for each segment.
Chapter 12: Concluding Insights of the report.

Please Note: Single-User license will be delivered via PDF from the publisher without the rights to print or to edit.


1 Market Overview
1.1 Product Definition
1.2 Market Analysis by Type
1.2.1 Global Software as a Medical Device (SaMD) Market Size Growth Rate by Type: 2020 VS 2024 VS 2031
1.2.2 Cloud-based
1.2.3 On Premise
1.3 Market Analysis by Application
1.3.1 Global Software as a Medical Device (SaMD) Market Size Growth Rate by Application: 2020 VS 2024 VS 2031
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 Market Growth Prospects
1.5 Global Software as a Medical Device (SaMD) Growth Trends by Region
1.5.1 Global Software as a Medical Device (SaMD) Market Size by Region: 2020 VS 2024 VS 2031
1.5.2 Software as a Medical Device (SaMD) Market Size by Region (2020-2025)
1.5.3 Software as a Medical Device (SaMD) Market Size by Region (2026-2031)
1.6 Assumptions and Limitations
1.7 Study Goals and Objectives
1.8 Years Considered
2 Global Software as a Medical Device (SaMD) Market Dynamics
2.1 Software as a Medical Device (SaMD) Industry Trends
2.2 Software as a Medical Device (SaMD) Industry Drivers
2.3 Software as a Medical Device (SaMD) Industry Opportunities and Challenges
2.4 Software as a Medical Device (SaMD) Industry Restraints
3 Competitive Landscape by Company
3.1 Global Software as a Medical Device (SaMD) Revenue by Company (2020-2025)
3.2 Global Software as a Medical Device (SaMD) Players Revenue Ranking, 2023 VS 2024 VS 2025
3.3 Global Software as a Medical Device (SaMD) Key Company Head office and Area Served
3.4 Global Software as a Medical Device (SaMD) Company, Product Type & Application
3.5 Global Software as a Medical Device (SaMD) Company Establishment Date
3.6 Market Competitive Analysis
3.6.1 Global Software as a Medical Device (SaMD) Market CR5 and HHI
3.6.2 Global Top 5 and 10 Software as a Medical Device (SaMD) Players Market Share by Revenue in 2024
3.6.3 2024 Software as a Medical Device (SaMD) Tier 1, Tier 2, and Tier 3
4 Software as a Medical Device (SaMD) Market by Type
4.1 Global Software as a Medical Device (SaMD) Market Size by Type (2020 VS 2024 VS 2031)
4.2 Global Software as a Medical Device (SaMD) Market Size by Type (2020-2031)
4.3 Global Software as a Medical Device (SaMD) Market Size Share by Type (2020-2031)
5 Software as a Medical Device (SaMD) Market by Application
5.1 Global Software as a Medical Device (SaMD) Market Size by Application (2020 VS 2024 VS 2031)
5.2 Global Software as a Medical Device (SaMD) Market Size by Application (2020-2031)
5.3 Global Software as a Medical Device (SaMD) Market Size Share by Application (2020-2031)
6 Company Profiles
6.1 MindMaze
6.1.1 MindMaze Comapny Information
6.1.2 MindMaze Business Overview
6.1.3 MindMaze Software as a Medical Device (SaMD) Revenue and Gross Margin (US$ Million) & (2020-2025)
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 Comapny Information
6.2.2 Medtronic Business Overview
6.2.3 Medtronic Software as a Medical Device (SaMD) Revenue and Gross Margin (US$ Million) & (2020-2025)
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. Comapny Information
6.3.2 Viz.AI. Business Overview
6.3.3 Viz.AI. Software as a Medical Device (SaMD) Revenue and Gross Margin (US$ Million) & (2020-2025)
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 Comapny Information
6.4.2 Siemens Healthcare Business Overview
6.4.3 Siemens Healthcare Software as a Medical Device (SaMD) Revenue and Gross Margin (US$ Million) & (2020-2025)
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 Comapny Information
6.5.2 iSchemaView Business Overview
6.5.3 iSchemaView Software as a Medical Device (SaMD) Revenue and Gross Margin (US$ Million) & (2020-2025)
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 Comapny Information
6.6.2 Arterys Business Overview
6.6.3 Arterys Software as a Medical Device (SaMD) Revenue and Gross Margin (US$ Million) & (2020-2025)
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 Comapny Information
6.7.2 Adherium Business Overview
6.7.3 Adherium Software as a Medical Device (SaMD) Revenue and Gross Margin (US$ Million) & (2020-2025)
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 Comapny Information
6.8.2 Digital Diagnostics Business Overview
6.8.3 Digital Diagnostics Software as a Medical Device (SaMD) Revenue and Gross Margin (US$ Million) & (2020-2025)
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 Comapny Information
6.9.2 Allscripts Business Overview
6.9.3 Allscripts Software as a Medical Device (SaMD) Revenue and Gross Margin (US$ Million) & (2020-2025)
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 (2020-2031)
7.2 North America Software as a Medical Device (SaMD) Market Size by Type
7.2.1 North America Software as a Medical Device (SaMD) Market Size by Type (2020-2025)
7.2.2 North America Software as a Medical Device (SaMD) Market Size by Type (2026-2031)
7.2.3 North America Software as a Medical Device (SaMD) Market Share by Type (2020-2031)
7.3 North America Software as a Medical Device (SaMD) Market Size by Application
7.3.1 North America Software as a Medical Device (SaMD) Market Size by Application (2020-2025)
7.3.2 North America Software as a Medical Device (SaMD) Market Size by Application (2026-2031)
7.3.3 North America Software as a Medical Device (SaMD) Market Share by Application (2020-2031)
7.4 North America Software as a Medical Device (SaMD) Market Size by Country
7.4.1 North America Software as a Medical Device (SaMD) Market Size by Country (2020 VS 2024 VS 2031)
7.4.2 North America Software as a Medical Device (SaMD) Market Size by Country (2020-2025)
7.4.3 North America Software as a Medical Device (SaMD) Market Size by Country (2026-2031)
7.4.4 North America Software as a Medical Device (SaMD) Market Share by Country (2020-2031)
7.4.5 United States
7.4.6 Canada
7.4.7 Mexico
8 Europe
8.1 Europe Software as a Medical Device (SaMD) Market Size (2020-2031)
8.2 Europe Software as a Medical Device (SaMD) Market Size by Type
8.2.1 Europe Software as a Medical Device (SaMD) Market Size by Type (2020-2025)
8.2.2 Europe Software as a Medical Device (SaMD) Market Size by Type (2026-2031)
8.2.3 Europe Software as a Medical Device (SaMD) Market Share by Type (2020-2031)
8.3 Europe Software as a Medical Device (SaMD) Market Size by Application
8.3.1 Europe Software as a Medical Device (SaMD) Market Size by Application (2020-2025)
8.3.2 Europe Software as a Medical Device (SaMD) Market Size by Application (2026-2031)
8.3.3 Europe Software as a Medical Device (SaMD) Market Share by Application (2020-2031)
8.4 Europe Software as a Medical Device (SaMD) Market Size by Country
8.4.1 Europe Software as a Medical Device (SaMD) Market Size by Country (2020 VS 2024 VS 2031)
8.4.2 Europe Software as a Medical Device (SaMD) Market Size by Country (2020-2025)
8.4.3 Europe Software as a Medical Device (SaMD) Market Size by Country (2026-2031)
8.4.4 Europe Software as a Medical Device (SaMD) Market Share by Country (2020-2031)
8.4.5 Germany
8.4.6 France
8.4.7 U.K.
8.4.8 Italy
8.4.9 Russia
8.4.10 Nordic Countries
9 China
9.1 China Software as a Medical Device (SaMD) Market Size (2020-2031)
9.2 China Software as a Medical Device (SaMD) Market Size by Type
9.2.1 China Software as a Medical Device (SaMD) Market Size by Type (2020-2025)
9.2.2 China Software as a Medical Device (SaMD) Market Size by Type (2026-2031)
9.2.3 China Software as a Medical Device (SaMD) Market Share by Type (2020-2031)
9.3 China Software as a Medical Device (SaMD) Market Size by Application
9.3.1 China Software as a Medical Device (SaMD) Market Size by Application (2020-2025)
9.3.2 China Software as a Medical Device (SaMD) Market Size by Application (2026-2031)
9.3.3 China Software as a Medical Device (SaMD) Market Share by Application (2020-2031)
10 Asia (Excluding China)
10.1 Asia Software as a Medical Device (SaMD) Market Size (2020-2031)
10.2 Asia Software as a Medical Device (SaMD) Market Size by Type
10.2.1 Asia Software as a Medical Device (SaMD) Market Size by Type (2020-2025)
10.2.2 Asia Software as a Medical Device (SaMD) Market Size by Type (2026-2031)
10.2.3 Asia Software as a Medical Device (SaMD) Market Share by Type (2020-2031)
10.3 Asia Software as a Medical Device (SaMD) Market Size by Application
10.3.1 Asia Software as a Medical Device (SaMD) Market Size by Application (2020-2025)
10.3.2 Asia Software as a Medical Device (SaMD) Market Size by Application (2026-2031)
10.3.3 Asia Software as a Medical Device (SaMD) Market Share by Application (2020-2031)
10.4 Asia Software as a Medical Device (SaMD) Market Size by Country
10.4.1 Asia Software as a Medical Device (SaMD) Market Size by Country (2020 VS 2024 VS 2031)
10.4.2 Asia Software as a Medical Device (SaMD) Market Size by Country (2020-2025)
10.4.3 Asia Software as a Medical Device (SaMD) Market Size by Country (2026-2031)
10.4.4 Asia Software as a Medical Device (SaMD) Market Share by Country (2020-2031)
10.4.5 Japan
10.4.6 South Korea
10.4.7 Taiwan
10.4.8 Southeast Asia
10.4.9 India
10.4.10 Australia
11 South America, Middle East & Africa
11.1 South America, Middle East & Africa Software as a Medical Device (SaMD) Market Size (2020-2031)
11.2 South America, Middle East & Africa Software as a Medical Device (SaMD) Market Size by Type
11.2.1 South America, Middle East & Africa Software as a Medical Device (SaMD) Market Size by Type (2020-2025)
11.2.2 South America, Middle East & Africa Software as a Medical Device (SaMD) Market Size by Type (2026-2031)
11.2.3 South America, Middle East & Africa Software as a Medical Device (SaMD) Market Share by Type (2020-2031)
11.3 South America, Middle East & Africa Software as a Medical Device (SaMD) Market Size by Application
11.3.1 South America, Middle East & Africa Software as a Medical Device (SaMD) Market Size by Application (2020-2025)
11.3.2 South America, Middle East & Africa Software as a Medical Device (SaMD) Market Size by Application (2026-2031)
11.3.3 South America, Middle East & Africa Software as a Medical Device (SaMD) Market Share by Application (2020-2031)
11.4 South America, Middle East & Africa Software as a Medical Device (SaMD) Market Size by Country
11.4.1 South America, Middle East & Africa Software as a Medical Device (SaMD) Market Size by Country (2020 VS 2024 VS 2031)
11.4.2 South America, Middle East & Africa Software as a Medical Device (SaMD) Market Size by Country (2020-2025)
11.4.3 South America, Middle East & Africa Software as a Medical Device (SaMD) Market Size by Country (2026-2031)
11.4.4 South America, Middle East & Africa Software as a Medical Device (SaMD) Market Share by Country (2020-2031)
11.4.5 Brazil
11.4.6 South Africa
11.4.7 Saudi Arabia
11.4.8 Turkey
11.4.9 Argentina
11.4.9 UAE
11.4.9 Egypt
11.4.9 Chile
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
13.6 Disclaimer

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