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Software as a Medical Device Market Set for Rapid Growth Through 2034 as AI Innovation, Digital Health Adoption, and Regulatory Advances Reshape the Competitive Landscape

globenewswire.com
GEHC GE HealthCare Technologies Inc. is mentioned as a leading company in the SaMD market, which is projected for rapid growth. The article does not provide specific sentiment or performance data for GEHC itself, but its inclusion as a key player in a growing market suggests potential. PHG Koninklijke Philips N.V. is identified as a leading company in the rapidly growing SaMD market. The article focuses on market trends and growth drivers like AI and digital health, without providing specific sentiment or performance indicators for Philips. AI Aidoc is mentioned as a developer of clinical artificial intelligence tools for SaMD. The article highlights the growth of AI in healthcare and the overall SaMD market, but does not provide specific sentiment or financial details for Aidoc.

Software as a Medical Device Market Set for Rapid Growth Through 2034 as AI Innovation, Digital Health Adoption, and Regulatory Advances Reshape the Competitive Landscape Dublin, Sept. 17, 2026 (GLOBE NEWSWIRE) -- "Software as a Medical Device (SaMD) - Market Insights, Competitive Landscape, and Market Forecast - 2034" has been added to ResearchAndMarkets.com's offering.

Software as a Medical Device (SaMD) Market to Reach USD 8.90 Billion by 2034

The global software as a medical device (SaMD) market was valued at USD 2.10 billion in 2025 and is projected to reach USD 8.90 billion by 2034, expanding at a compound annual growth rate of 17.4% from 2026 to 2034. Market growth is being supported by the integration of artificial intelligence and machine learning into clinical software, rising adoption of digital therapeutics, expansion of remote care, and maturing regulatory pathways for software and adaptive algorithms.

SaMD solutions are increasingly used across diagnostic imaging, clinical decision support, disease monitoring, treatment planning, and software-based therapies. Prominent products and platforms include LumineticsCore for diabetic retinopathy detection, clinical artificial intelligence tools from Viz.ai and Aidoc, and digital therapeutic solutions developed by companies such as WellDoc. Regulatory oversight is shaped by the International Medical Device Regulators Forum framework, the U.S. Food and Drug Administration, the European Union Medical Device Regulation, and aligned national requirements.

Software as a Medical Device Market Highlights

Key Software as a Medical Device Market Growth Drivers

Artificial intelligence and machine learning are transforming medical software by enabling the analysis of medical images, physiological signals, genetic information, and electronic health records. These capabilities support disease detection, clinical triage, diagnostic accuracy, workflow prioritization, and evidence-based decision-making. The growing number of FDA-authorized artificial intelligence-enabled medical devices, particularly in radiology and cardiology, demonstrates the increasing clinical and commercial adoption of these technologies.

Digital therapeutics are also extending the role of SaMD from diagnosis and monitoring into treatment. Software-based interventions are being developed for chronic, behavioral, and neurological conditions, including diabetes and substance use disorders. Demand is supported by the scalability of digital treatment, expanding clinical evidence, and the ability to improve access for underserved patient populations.

Additional growth factors include the expansion of telehealth, connected care, cloud computing, and remote patient monitoring. Rising chronic disease prevalence is increasing demand for scalable diagnostic, monitoring, and treatment solutions. Regulatory initiatives, including predetermined change control plans for artificial intelligence-enabled software, are also creating clearer pathways for product updates and algorithm development.

Market Segment Analysis

Diagnostic and screening software dominated the SaMD market in 2025, supported by the maturity of diagnostic artificial intelligence and the high volume of authorized imaging and data-analysis applications. These solutions are widely used in radiology, cardiology, ophthalmology, pathology, and other specialties to detect, characterize, and prioritize clinical findings.

Radiology and medical imaging represented the largest application segment. SaMD platforms analyze computed tomography, magnetic resonance imaging, and other imaging modalities to identify conditions such as stroke, fractures, and nodules. The volume of medical imaging procedures, demand for faster triage, and established clinical use of imaging artificial intelligence are expected to maintain the segment's leadership.

Cloud-based solutions accounted for the largest deployment share, reflecting demand for scalable access, centralized updates, data integration, and efficient implementation across healthcare networks. Hospitals and clinics remained the principal end users due to their adoption of diagnostic, decision-support, imaging, and patient-monitoring platforms.

Regional Market Outlook

North America held 45% of the global software as a medical device market in 2025. Regional leadership is supported by an advanced regulatory environment, substantial healthcare technology investment, strong clinical software adoption, and a high concentration of medical technology, artificial intelligence, and digital health companies. The United States remains the largest national market, benefiting from FDA pathways for SaMD and artificial intelligence-enabled devices.

Asia-Pacific is forecast to register the fastest growth through 2034. China, Japan, India, and South Korea are expanding healthcare infrastructure, digital health investment, and clinical artificial intelligence adoption. Population scale, rising chronic disease prevalence, and increasing access to connected healthcare platforms are expected to generate significant long-term opportunities.

Europe remains an important market, supported by adoption across Germany, the United Kingdom, France, Italy, and Spain. Development is influenced by the European Union Medical Device Regulation and emerging artificial intelligence requirements. Latin America, the Middle East, and Africa represent developing opportunities as digital infrastructure and cloud-delivered clinical software become more widely available.

Competitive Landscape

The global SaMD market is fragmented, with competition among medical technology companies, imaging specialists, clinical artificial intelligence developers, digital therapeutics providers, and health technology platforms. Competitive differentiation depends on clinical performance, regulatory authorization, workflow integration, cybersecurity, reimbursement, product breadth, and the ability to demonstrate measurable healthcare value.

Leading software as a medical device companies include:

Strategic activity includes partnerships with healthcare systems, integration with electronic health records and imaging platforms, acquisitions of artificial intelligence developers, and investment in digital therapeutics. In June 2023, Huma Therapeutics received FDA Class II clearance for a disease-agnostic SaMD platform, supporting the configuration of regulated software across multiple conditions. The FDA's 2021 artificial intelligence and machine learning SaMD action plan also helped advance tailored oversight for algorithm-based medical software.

Market Challenges

Growth may be moderated by complex regulatory submissions, costly clinical validation, inconsistent reimbursement, cybersecurity obligations, data privacy requirements, and integration challenges. Developers must also address algorithmic bias, performance across diverse populations, lifecycle management, and liability for software-supported clinical decisions. Adoption can be slowed by clinician acceptance, interoperability limitations, and the need to demonstrate clear clinical and economic benefits.

Software as a Medical Device Market Segmentation

Market Outlook

The software as a medical device market is positioned for sustained expansion as healthcare providers adopt artificial intelligence-enabled diagnostics, digital therapeutics, remote monitoring, and cloud-based clinical platforms. Companies that combine regulatory readiness, robust clinical evidence, seamless workflow integration, and scalable deployment are expected to capture emerging opportunities through 2034.

Key Topics Covered:

1. Introduction

1.1. Scope of the Report

1.2. Market Segmentation

1.3. Market Overview at a Glance

2. Executive Summary of Software as a Medical Device (SaMD) Market

2.1. Key Highlights and Market Snapshot

3. Key Factors Impacting the Software as a Medical Device (SaMD) Market

3.1. Market Drivers

3.1.1. Integration of Artificial Intelligence and Machine Learning into Clinical Software

3.1.2. Growth of Digital Therapeutics and Software-Based Treatment

3.1.3. Maturation of Regulatory Pathways for Software and Adaptive Algorithms

3.1.4. Diagnostic Support, Connected Care, and Scalable Software

3.2. Market Restraints

3.2.1. Regulatory Complexity and Adaptive Algorithm Challenges

3.2.2. Reimbursement and Clinical Validation Constraints

3.2.3. Clinical Adoption, Integration, and Liability

3.3. Market Opportunities

3.3.1. Artificial Intelligence, Digital Therapeutics, and Adaptive Software

3.3.2. Emerging Markets and Connected Care

4. Impact Analysis: AI, Geopolitical, Trade, and Economic Developments

5. Regulatory Analysis

5.1. The United States

5.2. Europe

5.3. Japan

5.4. China

6. Porter's Five Forces Analysis

6.1. Bargaining Power of Suppliers

6.2. Bargaining Power of Consumers

6.3. Threat of New Entrants

6.4. Threat of Substitutes

6.5. Competitive Rivalry

7. Software as a Medical Device (SaMD) Market Assessment

7.1. By Type

7.1.1. Diagnostic and Screening Software

7.1.2. Clinical Decision Support Software

7.1.3. Digital Therapeutics

7.1.4. Monitoring and Treatment Planning Software

7.2. By Application

7.2.1. Radiology and Medical Imaging

7.2.2. Cardiology

7.2.3. Neurology

7.2.4. Ophthalmology

7.2.5. Others

7.3. By Deployment

7.3.1. Cloud-Based

7.3.2. On-Premise and Embedded

7.4. By End-User

7.4.1. Hospitals and Clinics

7.4.2. Patients and Consumers

7.4.3. Diagnostic and Imaging Centers

7.4.4. Others

7.5. By Geography

7.5.1. North America

7.5.1.1. United States Software as a Medical Device Market Size in USD million (2023-2034)

7.5.1.2. Canada Software as a Medical Device Market Size in USD million (2023-2034)

7.5.1.3. Mexico Software as a Medical Device Market Size in USD million (2023-2034)

7.5.2. Europe

7.5.2.1. Germany Software as a Medical Device Market Size in USD million (2023-2034)

7.5.2.2. United Kingdom Software as a Medical Device Market Size in USD million (2023-2034)

7.5.2.3. France Software as a Medical Device Market Size in USD million (2023-2034)

7.5.2.4. Italy Software as a Medical Device Market Size in USD million (2023-2034)

7.5.2.5. Spain Software as a Medical Device Market Size in USD million (2023-2034)

7.5.2.6. Rest of Europe Software as a Medical Device Market Size in USD million (2023-2034)

7.5.3. Asia-Pacific

7.5.3.1. China Software as a Medical Device Market Size in USD million (2023-2034)

7.5.3.2. Japan Software as a Medical Device Market Size in USD million (2023-2034)

7.5.3.3. India Software as a Medical Device Market Size in USD million (2023-2034)

7.5.3.4. Australia Software as a Medical Device Market Size in USD million (2023-2034)

7.5.3.5. South Korea Software as a Medical Device Market Size in USD million (2023-2034)

7.5.3.6. Rest of Asia-Pacific Software as a Medical Device Market Size in USD million (2023-2034)

7.5.4. Rest of the World

7.5.4.1. Middle East Software as a Medical Device Market Size in USD million (2023-2034)

7.5.4.2. Africa Software as a Medical Device Market Size in USD million (2023-2034)

7.5.4.3. South America Software as a Medical Device Market Size in USD million (2023-2034)

8. Software as a Medical Device (SaMD) Market Competitive Landscape

8.1. Competitive Analysis

8.2. Company Share Analysis (Premium Offering)

9. Software as a Medical Device (SaMD) Market Startup Funding and Investment Trends

10. Company and Product Profiles

10.1. Koninklijke Philips N.V.

10.1.1. Company Overview

10.1.2. Company Snapshot

10.1.3. Financial Overview

10.1.4. Product Portfolio

10.1.5. Strategic Initiatives / Entropy

10.2. Siemens Healthineers AG

10.2.1. Company Overview

10.2.2. Company Snapshot

10.2.3. Financial Overview

10.2.4. Product Portfolio

10.2.5. Strategic Initiatives / Entropy

10.3. GE HealthCare Technologies Inc.

10.3.1. Company Overview

10.3.2. Company Snapshot

10.3.3. Financial Overview

10.3.4. Product Portfolio

10.3.5. Strategic Initiatives / Entropy

10.4. Medtronic plc

10.4.1. Company Overview

10.4.2. Company Snapshot

10.4.3. Financial Overview

10.4.4. Product Portfolio

10.4.5. Strategic Initiatives / Entropy

10.5. Aidoc Medical Ltd.

10.5.1. Company Overview

10.5.2. Company Snapshot

10.5.3. Financial Overview

10.5.4. Product Portfolio

10.5.5. Strategic Initiatives / Entropy

10.6. Viz.ai, Inc.

10.6.1. Company Overview

10.6.2. Company Snapshot

10.6.3. Financial Overview

10.6.4. Product Portfolio

10.6.5. Strategic Initiatives / Entropy

10.7. Digital Diagnostics Inc.

10.7.1. Company Overview

10.7.2. Company Snapshot

10.7.3. Financial Overview

10.7.4. Product Portfolio

10.7.5. Strategic Initiatives / Entropy

10.8. HeartFlow, Inc.

10.8.1. Company Overview

10.8.2. Company Snapshot

10.8.3. Financial Overview

10.8.4. Product Portfolio

10.8.5. Strategic Initiatives / Entropy

10.9. Cognoa, Inc.

10.9.1. Company Overview

10.9.2. Company Snapshot

10.9.3. Financial Overview

10.9.4. Product Portfolio

10.9.5. Strategic Initiatives / Entropy

10.10. Huma Therapeutics Limited

10.10.1. Company Overview

10.10.2. Company Snapshot

10.10.3. Financial Overview

10.10.4. Product Portfolio

10.10.5. Strategic Initiatives / Entropy

For illustrative purposes, only the top 10 companies are listed in the Table of Contents. The report may include analysis and references to additional companies where relevant to the market assessment.

11. KOL Views

12. Project Approach

13. About the Publisher

14. Disclaimer and Contact Us

List of Tables

Table 1: Global Software as a Medical Device Market Size in USD million (2023-2034)

Table 2: Global Software as a Medical Device Market Size by Type in USD million (2023-2034)

Table 3: Global Software as a Medical Device Market Size by Application in USD million (2023-2034)

Table 4: Global Software as a Medical Device Market Size by Deployment in USD million (2023-2034)

Table 5: Global Software as a Medical Device Market Size by End-User in USD million (2023-2034)

Table 6: Software as a Medical Device Market Size in North America in USD million (2023-2034)

Table 7: Software as a Medical Device Market Size in the United States in USD million (2023-2034)

Table 8: Software as a Medical Device Market Size in Canada in USD million (2023-2034)

Table 9: Software as a Medical Device Market Size in Mexico in USD million (2023-2034)

Table 10: Software as a Medical Device Market Size in Europe in USD million (2023-2034)

Table 11: Software as a Medical Device Market Size in Germany in USD million (2023-2034)

Table 12: Software as a Medical Device Market Size in the United Kingdom in USD million (2023-2034)

Table 13: Software as a Medical Device Market Size in France in USD million (2023-2034)

Table 14: Software as a Medical Device Market Size in Italy in USD million (2023-2034)

Table 15: Software as a Medical Device Market Size in Spain in USD million (2023-2034)

Table 16: Software as a Medical Device Market Size in the Rest of Europe in USD million (2023-2034)

Table 17: Software as a Medical Device Market Size in Asia-Pacific in USD million (2023-2034)

Table 18: Software as a Medical Device Market Size in China in USD million (2023-2034)

Table 19: Software as a Medical Device Market Size in Japan in USD million (2023-2034)

Table 20: Software as a Medical Device Market Size in India in USD million (2023-2034)

Table 21: Software as a Medical Device Market Size in Australia in USD million (2023-2034)

Table 22: Software as a Medical Device Market Size in South Korea in USD million (2023-2034)

Table 23: Software as a Medical Device Market Size in the Rest of Asia-Pacific in USD million (2023-2034)

Table 24: Software as a Medical Device Market Size in the Rest of the World in USD million (2023-2034)

Table 25: Software as a Medical Device Market Size in the Middle East in USD million (2023-2034)

Table 26: Software as a Medical Device Market Size in Africa in USD million (2023-2034)

Table 27: Software as a Medical Device Market Size in South America in USD million (2023-2034)

Table 28: Software as a Medical Device Market Competitive Landscape

Table 29: Software as a Medical Device Market Startup Funding and Investment Trends

List of Figures

Figure 1: Software as a Medical Device Market Drivers

Figure 2: Software as a Medical Device Market Restraints

Figure 3: Software as a Medical Device Market Opportunities

Figure 4: Impact Analysis: AI, Geopolitical, Trade, and Economic Developments

Figure 5: Regulatory Analysis of the Software as a Medical Device Market (the United States)

Figure 6: Regulatory Analysis of the Software as a Medical Device Market (Europe)

Figure 7: Regulatory Analysis of the Software as a Medical Device Market (Japan)

Figure 8: Regulatory Analysis of the Software as a Medical Device Market (China)

Figure 9: Porter's Five Forces Analysis of the Software as a Medical Device Market

Figure 10: Competitive Analysis of the Software as a Medical Device Market

Figure 11: Global Software as a Medical Device Market Size in USD million (2023-2034)

Figure 12: Global Software as a Medical Device Market Size by Type in USD million (2023-2034)

Figure 13: Global Software as a Medical Device Market Size by Application in USD million (2023-2034)

Figure 14: Global Software as a Medical Device Market Size by Deployment in USD million (2023-2034)

Figure 15: Global Software as a Medical Device Market Size by End-User in USD million (2023-2034)

Figure 16: Software as a Medical Device Market Size in North America in USD million (2023-2034)

Figure 17: Software as a Medical Device Market Size in the United States in USD million (2023-2034)

Figure 18: Software as a Medical Device Market Size in Canada in USD million (2023-2034)

Figure 19: Software as a Medical Device Market Size in Mexico in USD million (2023-2034)

Figure 20: Software as a Medical Device Market Size in Europe in USD million (2023-2034)

Figure 21: Software as a Medical Device Market Size in Germany in USD million (2023-2034)

Figure 22: Software as a Medical Device Market Size in the United Kingdom in USD million (2023-2034)

Figure 23: Software as a Medical Device Market Size in France in USD million (2023-2034)

Figure 24: Software as a Medical Device Market Size in Italy in USD million (2023-2034)

Figure 25: Software as a Medical Device Market Size in Spain in USD million (2023-2034)

Figure 26: Software as a Medical Device Market Size in the Rest of Europe in USD million (2023-2034)

Figure 27: Software as a Medical Device Market Size in Asia-Pacific in USD million (2023-2034)

Figure 28: Software as a Medical Device Market Size in China in USD million (2023-2034)

Figure 29: Software as a Medical Device Market Size in Japan in USD million (2023-2034)

Figure 30: Software as a Medical Device Market Size in India in USD million (2023-2034)

Figure 31: Software as a Medical Device Market Size in Australia in USD million (2023-2034)

Figure 32: Software as a Medical Device Market Size in South Korea in USD million (2023-2034)

Figure 33: Software as a Medical Device Market Size in the Rest of Asia-Pacific in USD million (2023-2034)

Figure 34: Software as a Medical Device Market Size in the Rest of the World in USD million (2023-2034)

Figure 35: Software as a Medical Device Market Size in the Middle East in USD million (2023-2034)

Figure 36: Software as a Medical Device Market Size in Africa in USD million (2023-2034)

Figure 37: Software as a Medical Device Market Size in South America in USD million (2023-2034)

A selection of companies mentioned in this report includes, but is not limited to:

For more information about this report visit https://www.researchandmarkets.com/r/ig2ysm

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