Global Software as a Medical Device (SaMD) Competitive Landscape Professional Research Report 2025

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 was valued at XX Million USD in 2024 and is projected to reach XX Million USD by 2032, with a CAGR of XX% (2025-2032). Notably, the China market has changed rapidly in the past few years. By 2024, China's market size is expected to be XX Million USD, representing approximately XX% of the global market share. By 2032, it is anticipated to grow further to XX Million USD, contributing XX% to the worldwide market share.

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 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, sales, 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 2020 to 2024, based year in 2025 and forecast data from 2026 to 2032.

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 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 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