The software as a medical device (samd) market size has grown exponentially in recent years. It will grow from $38.02 billion in 2025 to $47.26 billion in 2026 at a compound annual growth rate (CAGR) of 24.3%. The growth in the historic period can be attributed to telemedicine adoption, smartphone penetration, digital health funding, regulatory clarity, demand for remote care.
The software as a medical device (samd) market size is expected to see exponential growth in the next few years. It will grow to $120.54 billion in 2030 at a compound annual growth rate (CAGR) of 26.4%. The growth in the forecast period can be attributed to virtual care expansion, software driven diagnostics, cloud healthcare platforms, outcome based reimbursement, hospital software modernization. Major trends in the forecast period include expansion of clinical decision support software, growth of remote diagnostic applications, increased regulatory validation of medical software, subscription based samd business models, integration with electronic health records.
The increasing prevalence of chronic diseases is increasingly supporting the expansion of the software as a medical device market going forward. Chronic diseases are long-term health conditions such as diabetes, heart disease, and arthritis that progress gradually and require ongoing management. The rise in chronic diseases is largely associated with unhealthy lifestyles, including poor dietary habits, physical inactivity, and smoking. Software as a medical device supports chronic disease management by enabling continuous health monitoring, early complication detection, and personalized treatment insights. It also facilitates remote care and reduces the need for frequent hospital visits. For example, in June 2024, according to the National Health Service, 3,615,330 individuals in the UK were diagnosed with non-diabetic hyperglycemia in 2023, reflecting an 18% increase compared to 2022. As a result, the growing burden of chronic diseases is reinforcing demand for software as a medical device solutions.
Leading companies operating in the software as a medical device (SaMD) market are increasing their focus on introducing advanced software solutions, such as SOMNUM, to strengthen their competitive position. SOMNUM is a sleep disease analysis software that combines recent AI research trends with diagnostic algorithms based on multi-channel sleep biosignal data rather than video imaging. For example, in September 2023, HoneyNaps Co. Ltd., a South Korea-based software company, received approval from the United States Food and Drug Administration for SOMNUM software. The platform uses deep learning-based AI to perform real-time analysis of sleep biosignals, including electroencephalograms, electrooculograms, electromyograms, electrocardiograms, respiratory airflow and effort, and oxygen saturation. The software delivers more accurate and advanced readings than conventional approaches and reduces sleep data analysis time to under five minutes.
In October 2024, GE HealthCare Technologies Inc., a US-based medical technology company, acquired the clinical AI business of Intelligent Ultrasound Group plc for $53 million. Through this acquisition, GE HealthCare expanded its AI-powered imaging portfolio, strengthening real-time ultrasound analysis capabilities and supporting advanced clinical decision-making to improve patient outcomes. Intelligent Ultrasound Group plc is a UK-based medical technology company specializing in AI-powered ultrasound software.
Major companies operating in the software as a medical device (samd) market are Apple Inc., Abbott Laboratories, Siemens Healthcare GmbH, GE HealthCare Technologies Inc., Roche Diagnostics, Cerner Corporation, Philips Medical Systems Ltd., Dexcom Inc., Carl Zeiss Meditec AG, Nihon Kohden Corporation, Viz.ai Inc., S3 Connected Health, Arterys Inc., BrightInsight Inc., Agfa HealthCare Corp., iSchemaView Inc., VitalConnect Inc., Volpara Health Technologies, Greenfinch Technology Ltd., MaxQ AI Ltd., IDx Technologies Inc.
North America was the largest region in the software as a medical device (SaMD) market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the software as a medical device (samd) market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the software as a medical device (samd) market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
Tariffs moderately impact the SaMD market through increased costs for imported IT hardware, servers, and deployment infrastructure, particularly in North America and Asia-Pacific regions. Cloud-based and mobile segments are less affected, while on-premise deployments face higher setup costs. Positive effects include accelerated cloud migration and increased domestic software development investments.
The software as a medical device (samd) market research report is one of a series of new reports that provides software as a medical device (samd) market statistics, including software as a medical device (samd) industry global market size, regional shares, competitors with a software as a medical device (samd) market share, detailed software as a medical device (samd) market segments, market trends and opportunities, and any further data you may need to thrive in the software as a medical device (samd) industry. This software as a medical device (samd) market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
Software as a medical device (SaMD) refers to software specifically intended to perform medical functions without being part of a physical medical device. It includes applications developed for diagnosis, treatment, or monitoring of medical conditions and is recognized as a distinct category within medical device regulation.
The primary device categories in software as a medical device (SaMD) include wearable devices, personal computers and laptops, and smartphones and tablets. Wearable devices are electronic products designed to be worn on or within the body and communicate with other systems to collect or transmit health-related data. These solutions support both cloud-based and on-premise deployment models and are used across applications such as diagnostics and clinical management.
The software as a medical device (SaMD) market consists of revenues earned by entities by providing diagnostic assistance, treatment planning and guidance, monitoring and remote patient management services. The market value includes the value of related goods sold by the service provider or included within the service offering. The SaMD (software as a medical device) market also includes sales of clinical decision support systems, digital diagnostics and screening tools, personal health and wellness apps, radiology imaging software, and diabetic management apps, which are used in providing SaMD (software as a medical device) services. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
This product will be delivered within 1-3 business days.
The software as a medical device (samd) market size is expected to see exponential growth in the next few years. It will grow to $120.54 billion in 2030 at a compound annual growth rate (CAGR) of 26.4%. The growth in the forecast period can be attributed to virtual care expansion, software driven diagnostics, cloud healthcare platforms, outcome based reimbursement, hospital software modernization. Major trends in the forecast period include expansion of clinical decision support software, growth of remote diagnostic applications, increased regulatory validation of medical software, subscription based samd business models, integration with electronic health records.
The increasing prevalence of chronic diseases is increasingly supporting the expansion of the software as a medical device market going forward. Chronic diseases are long-term health conditions such as diabetes, heart disease, and arthritis that progress gradually and require ongoing management. The rise in chronic diseases is largely associated with unhealthy lifestyles, including poor dietary habits, physical inactivity, and smoking. Software as a medical device supports chronic disease management by enabling continuous health monitoring, early complication detection, and personalized treatment insights. It also facilitates remote care and reduces the need for frequent hospital visits. For example, in June 2024, according to the National Health Service, 3,615,330 individuals in the UK were diagnosed with non-diabetic hyperglycemia in 2023, reflecting an 18% increase compared to 2022. As a result, the growing burden of chronic diseases is reinforcing demand for software as a medical device solutions.
Leading companies operating in the software as a medical device (SaMD) market are increasing their focus on introducing advanced software solutions, such as SOMNUM, to strengthen their competitive position. SOMNUM is a sleep disease analysis software that combines recent AI research trends with diagnostic algorithms based on multi-channel sleep biosignal data rather than video imaging. For example, in September 2023, HoneyNaps Co. Ltd., a South Korea-based software company, received approval from the United States Food and Drug Administration for SOMNUM software. The platform uses deep learning-based AI to perform real-time analysis of sleep biosignals, including electroencephalograms, electrooculograms, electromyograms, electrocardiograms, respiratory airflow and effort, and oxygen saturation. The software delivers more accurate and advanced readings than conventional approaches and reduces sleep data analysis time to under five minutes.
In October 2024, GE HealthCare Technologies Inc., a US-based medical technology company, acquired the clinical AI business of Intelligent Ultrasound Group plc for $53 million. Through this acquisition, GE HealthCare expanded its AI-powered imaging portfolio, strengthening real-time ultrasound analysis capabilities and supporting advanced clinical decision-making to improve patient outcomes. Intelligent Ultrasound Group plc is a UK-based medical technology company specializing in AI-powered ultrasound software.
Major companies operating in the software as a medical device (samd) market are Apple Inc., Abbott Laboratories, Siemens Healthcare GmbH, GE HealthCare Technologies Inc., Roche Diagnostics, Cerner Corporation, Philips Medical Systems Ltd., Dexcom Inc., Carl Zeiss Meditec AG, Nihon Kohden Corporation, Viz.ai Inc., S3 Connected Health, Arterys Inc., BrightInsight Inc., Agfa HealthCare Corp., iSchemaView Inc., VitalConnect Inc., Volpara Health Technologies, Greenfinch Technology Ltd., MaxQ AI Ltd., IDx Technologies Inc.
North America was the largest region in the software as a medical device (SaMD) market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the software as a medical device (samd) market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the software as a medical device (samd) market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
Tariffs moderately impact the SaMD market through increased costs for imported IT hardware, servers, and deployment infrastructure, particularly in North America and Asia-Pacific regions. Cloud-based and mobile segments are less affected, while on-premise deployments face higher setup costs. Positive effects include accelerated cloud migration and increased domestic software development investments.
The software as a medical device (samd) market research report is one of a series of new reports that provides software as a medical device (samd) market statistics, including software as a medical device (samd) industry global market size, regional shares, competitors with a software as a medical device (samd) market share, detailed software as a medical device (samd) market segments, market trends and opportunities, and any further data you may need to thrive in the software as a medical device (samd) industry. This software as a medical device (samd) market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
Software as a medical device (SaMD) refers to software specifically intended to perform medical functions without being part of a physical medical device. It includes applications developed for diagnosis, treatment, or monitoring of medical conditions and is recognized as a distinct category within medical device regulation.
The primary device categories in software as a medical device (SaMD) include wearable devices, personal computers and laptops, and smartphones and tablets. Wearable devices are electronic products designed to be worn on or within the body and communicate with other systems to collect or transmit health-related data. These solutions support both cloud-based and on-premise deployment models and are used across applications such as diagnostics and clinical management.
The software as a medical device (SaMD) market consists of revenues earned by entities by providing diagnostic assistance, treatment planning and guidance, monitoring and remote patient management services. The market value includes the value of related goods sold by the service provider or included within the service offering. The SaMD (software as a medical device) market also includes sales of clinical decision support systems, digital diagnostics and screening tools, personal health and wellness apps, radiology imaging software, and diabetic management apps, which are used in providing SaMD (software as a medical device) services. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
This product will be delivered within 1-3 business days.
Table of Contents
1. Executive Summary
2. Software as a Medical Device (SaMD) Market Characteristics
3. Software as a Medical Device (SaMD) Market Supply Chain Analysis
4. Global Software as a Medical Device (SaMD) Market Trends and Strategies
5. Software as a Medical Device (SaMD) Market Analysis of End Use Industries
7. Global Software as a Medical Device (SaMD) Strategic Analysis Framework, Current Market Size, Market Comparisons and Growth Rate Analysis
8. Global Software as a Medical Device (SaMD) Total Addressable Market (TAM) Analysis for the Market
9. Software as a Medical Device (SaMD) Market Segmentation
10. Software as a Medical Device (SaMD) Market Regional and Country Analysis
11. Asia-Pacific Software as a Medical Device (SaMD) Market
12. China Software as a Medical Device (SaMD) Market
13. India Software as a Medical Device (SaMD) Market
14. Japan Software as a Medical Device (SaMD) Market
15. Australia Software as a Medical Device (SaMD) Market
16. Indonesia Software as a Medical Device (SaMD) Market
17. South Korea Software as a Medical Device (SaMD) Market
18. Taiwan Software as a Medical Device (SaMD) Market
19. South East Asia Software as a Medical Device (SaMD) Market
20. Western Europe Software as a Medical Device (SaMD) Market
21. UK Software as a Medical Device (SaMD) Market
22. Germany Software as a Medical Device (SaMD) Market
23. France Software as a Medical Device (SaMD) Market
24. Italy Software as a Medical Device (SaMD) Market
25. Spain Software as a Medical Device (SaMD) Market
26. Eastern Europe Software as a Medical Device (SaMD) Market
27. Russia Software as a Medical Device (SaMD) Market
28. North America Software as a Medical Device (SaMD) Market
29. USA Software as a Medical Device (SaMD) Market
30. Canada Software as a Medical Device (SaMD) Market
31. South America Software as a Medical Device (SaMD) Market
32. Brazil Software as a Medical Device (SaMD) Market
33. Middle East Software as a Medical Device (SaMD) Market
34. Africa Software as a Medical Device (SaMD) Market
36. Software as a Medical Device (SaMD) Market Competitive Landscape and Company Profiles
37. Software as a Medical Device (SaMD) Market Other Major and Innovative Companies
40. Software as a Medical Device (SaMD) Market High Potential Countries, Segments and Strategies
41. Appendix
List of Tables
Executive Summary
Software As A Medical Device (SaMD) Market Global Report 2026 provides strategists, marketers and senior management with the critical information they need to assess the market.This report focuses software as a medical device (samd) market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
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Description
Where is the largest and fastest growing market for software as a medical device (samd)? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The software as a medical device (samd) market global report answers all these questions and many more.The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.
- The market characteristics section of the report defines and explains the market. This section also examines key products and services offered in the market, evaluates brand-level differentiation, compares product features, and highlights major innovation and product development trends.
- The supply chain analysis section provides an overview of the entire value chain, including key raw materials, resources, and supplier analysis. It also provides a list competitor at each level of the supply chain.
- The updated trends and strategies section analyses the shape of the market as it evolves and highlights emerging technology trends such as digital transformation, automation, sustainability initiatives, and AI-driven innovation. It suggests how companies can leverage these advancements to strengthen their market position and achieve competitive differentiation.
- The regulatory and investment landscape section provides an overview of the key regulatory frameworks, regularity bodies, associations, and government policies influencing the market. It also examines major investment flows, incentives, and funding trends shaping industry growth and innovation.
- The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
- The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.
- The total addressable market (TAM) analysis section defines and estimates the market potential compares it with the current market size, and provides strategic insights and growth opportunities based on this evaluation.
- The market attractiveness scoring section evaluates the market based on a quantitative scoring framework that considers growth potential, competitive dynamics, strategic fit, and risk profile. It also provides interpretive insights and strategic implications for decision-makers.
- Market segmentations break down the market into sub markets.
- The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth.
- Expanded geographical coverage includes Taiwan and Southeast Asia, reflecting recent supply chain realignments and manufacturing shifts in the region. This section analyzes how these markets are becoming increasingly important hubs in the global value chain.
- The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
- The company scoring matrix section evaluates and ranks leading companies based on a multi-parameter framework that includes market share or revenues, product innovation, and brand recognition.
Report Scope
Markets Covered:
1) By Device Type: Wearable Device; PCs And Laptop; Smartphone And Tablets2) By Deployment Method: Cloud-Based; On-Premise
3) By Application: Diagnostic; Clinical Management
Subsegments:
1) By Wearable Devices: Smartwatches With Health Monitoring Functions; Fitness Trackers; Wearable ECG And Blood Pressure Monitors2) By PCs And Laptops: Medical Diagnostic Software; Clinical Decision Support Software; Telemedicine Platforms
3) By Smartphone And Tablets: Mobile Health (mHealth) Apps; Remote Patient Monitoring Software; Diagnostic Imaging Apps
Companies Mentioned: Apple Inc.; Abbott Laboratories; Siemens Healthcare GmbH; GE HealthCare Technologies Inc.; Roche Diagnostics; Cerner Corporation; Philips Medical Systems Ltd.; Dexcom Inc.; Carl Zeiss Meditec AG; Nihon Kohden Corporation; Viz.ai Inc.; S3 Connected Health; Arterys Inc.; BrightInsight Inc.; Agfa HealthCare Corp.; iSchemaView Inc.; VitalConnect Inc.; Volpara Health Technologies; Greenfinch Technology Ltd.; MaxQ AI Ltd.; IDx Technologies Inc.
Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Taiwan; Russia; South Korea; UK; USA; Canada; Italy; Spain
Regions: Asia-Pacific; South East Asia; Western Europe; Eastern Europe; North America; South America; Middle East; Africa
Time Series: Five years historic and ten years forecast.
Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita.
Data Segmentation: Country and regional historic and forecast data, market share of competitors, market segments.
Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.
Delivery Format: Word, PDF or Interactive Report + Excel Dashboard
Added Benefits:
- Bi-Annual Data Update
- Customisation
- Expert Consultant Support
Companies Mentioned
The companies featured in this Software as a Medical Device (SaMD) market report include:- Apple Inc.
- Abbott Laboratories
- Siemens Healthcare GmbH
- GE HealthCare Technologies Inc.
- Roche Diagnostics
- Cerner Corporation
- Philips Medical Systems Ltd.
- Dexcom Inc.
- Carl Zeiss Meditec AG
- Nihon Kohden Corporation
- Viz.ai Inc.
- S3 Connected Health
- Arterys Inc.
- BrightInsight Inc.
- Agfa HealthCare Corp.
- iSchemaView Inc.
- VitalConnect Inc.
- Volpara Health Technologies
- Greenfinch Technology Ltd.
- MaxQ AI Ltd.
- IDx Technologies Inc.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 250 |
| Published | February 2026 |
| Forecast Period | 2026 - 2030 |
| Estimated Market Value ( USD | $ 47.26 Billion |
| Forecasted Market Value ( USD | $ 120.54 Billion |
| Compound Annual Growth Rate | 26.4% |
| Regions Covered | Global |
| No. of Companies Mentioned | 22 |
