Global Software as a Medical Device Market to Observe Stupendous Growth at a CAGR of ~17% by 2034 | DelveInsight

The software as a medical device market is experiencing strong growth, driven by the increasing adoption of digital healthcare solutions, AI, machine learning, cloud computing, and connected medical technologies. The growing use of software for disease diagnosis, clinical decision-making, patient monitoring, treatment planning, and remote care is expanding the application of SaMD across hospitals, clinics, diagnostic centers, and home healthcare settings. In addition, the rising prevalence of chronic diseases and the growing demand for personalized and data-driven healthcare are encouraging healthcare providers to adopt advanced software-based solutions.

New York, USA, Sept. 29, 2026 (GLOBE NEWSWIRE) -- Global Software as a Medical Device Market to Observe Stupendous Growth at a CAGR of ~17% by 2034 | DelveInsight

The software as a medical device market is experiencing strong growth, driven by the increasing adoption of digital healthcare solutions, AI, machine learning, cloud computing, and connected medical technologies. The growing use of software for disease diagnosis, clinical decision-making, patient monitoring, treatment planning, and remote care is expanding the application of SaMD across hospitals, clinics, diagnostic centers, and home healthcare settings. In addition, the rising prevalence of chronic diseases and the growing demand for personalized and data-driven healthcare are encouraging healthcare providers to adopt advanced software-based solutions.

DelveInsight’s Software as a Medical Device Market Insights report provides the current and forecast market analysis, individual leading software as a medical device companies’ market shares, challenges, software as a medical device market drivers, barriers, trends, and key Software as a Medical Device companies in the market.

Software as a Medical Device Market Summary

• 2025 Software as a Medical Device Market Size: USD 2.1 Billion
• 2034 Projected Software as a Medical Device Market Size: USD 8.9 Billion
• Software as a Medical Device Market Growth Rate (2026-2034): ~17% 
• Largest Software as a Medical Device Market: North America
• Largest Type Segment: Diagnostic and Screening Software Category
• Key Companies in the Software as a Medical Device Market: Koninklijke Philips N.V., Siemens Healthineers AG, GE HealthCare Technologies Inc., Medtronic plc, and Aidoc Medical Ltd., alongside Viz.ai, Inc., Digital Diagnostics Inc., HeartFlow, Inc., Cognoa, Inc., Huma Therapeutics Limited, and others

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Key Factors Contributing to the Rise in Growth of the Software as a Medical Device Market

• Growing Adoption of Artificial Intelligence in Healthcare: The increasing use of artificial intelligence and machine learning in clinical applications is accelerating the adoption of SaMD. AI-powered software supports medical imaging, diagnosis, clinical decision-making, patient monitoring, and risk prediction.
• Increasing Demand for Digital Healthcare Solutions: Healthcare providers are increasingly adopting digital tools to improve care delivery, streamline clinical workflows, and enhance patient outcomes. The growing integration of digital health technologies into healthcare systems is supporting demand for SaMD solutions.
• Rising Prevalence of Chronic Diseases: The growing burden of chronic conditions, including cardiovascular diseases, diabetes, cancer, and neurological disorders, is increasing the need for continuous monitoring and efficient disease management. SaMD enables remote monitoring, clinical decision support, and personalized care.
• Expansion of Remote Patient Monitoring and Telehealth: The increasing adoption of telehealth and remote patient monitoring is creating demand for software capable of collecting, analyzing, and transmitting patient health information. SaMD solutions facilitate virtual consultations, remote diagnostics, and continuous patient monitoring.
• Advancements in Medical Imaging and Diagnostic Software: Technological advances in imaging analytics, computer-aided diagnosis, and automated image interpretation are expanding the use of SaMD in radiology, cardiology, pathology, and other diagnostic specialties. These solutions can improve workflow efficiency and support clinical interpretation.
• Favorable Regulatory Developments: Regulatory agencies are establishing clearer frameworks and pathways for digital health, AI-enabled medical software, and SaMD. Greater regulatory clarity is encouraging healthcare technology companies to develop and commercialize software-based medical solutions.
• Increasing Healthcare Expenditure and Digital Infrastructure Investment: Growing investments in healthcare IT infrastructure, cloud computing, connected medical devices, and digital transformation are providing the foundation for wider SaMD adoption. Hospitals and healthcare organizations are increasingly upgrading their technology infrastructure to support software-driven care.
• Growing Adoption of Cloud-Based Healthcare Solutions: The transition toward cloud-based platforms enables healthcare providers to deploy, update, and scale medical software more efficiently. Cloud infrastructure also supports secure data storage, interoperability, analytics, and integration across healthcare systems.
• Increasing Demand for Personalized and Precision Medicine: The growing focus on personalized healthcare is increasing the need for software capable of analyzing large volumes of clinical, genomic, and patient-generated data. SaMD can support treatment selection, disease risk assessment, and individualized clinical decision-making.
• Integration with Connected and Wearable Medical Technologies: The proliferation of wearable devices, connected sensors, and Internet of Medical Things technologies is generating large volumes of real-time health data. SaMD enables the analysis and interpretation of this information for monitoring, diagnosis, and disease management.

Get a sneak peek at the software as a medical device market dynamics @ Software as a Medical Device Costs

Regional Software as a Medical Device Market Insights

North America

• North America held the largest share of the global software as a medical device market in 2025, accounting for 45% of the total market. 
• The region’s leading position is supported by its well-established regulatory environment for software and artificial intelligence, strong concentration of clinical artificial intelligence and digital health companies, widespread adoption of clinical software, and substantial research and investment activity. 
• The United States represents the largest national market within the region, driven by the Food and Drug Administration’s regulatory framework and established pathways for software and artificial intelligence-enabled medical devices, the authorization of a growing number of artificial intelligence-enabled devices, the presence of major clinical artificial intelligence, medical imaging, and digital therapeutics companies, and high adoption of clinical software.
• The Food and Drug Administration has established dedicated policies, regulatory pathways, and guidance for software as a medical device, including the predetermined change control plan framework for artificial intelligence-enabled software. 
• In addition, the region’s advanced healthcare and technology infrastructure facilitates the development, commercialization, and adoption of software-based medical technologies. 
• Many leading companies in clinical artificial intelligence, medical imaging, and digital therapeutics are headquartered in or have significant operations across North America, contributing to the region’s advanced use of diagnostic, triage, and clinical decision-support software. 
• The combination of regulatory maturity, strong industry presence, high software adoption, and substantial investment activity reinforces North America’s market leadership. These factors are expected to support the region’s position as the largest regional market throughout the forecast period.

Europe

• Europe accounted for a significant share of the global software as a medical device market in 2025, supported by its established healthcare systems, mature regulatory environment, strong digital health ecosystem, and increasing adoption of software-based medical technologies.
• The region’s market is driven by the growing integration of artificial intelligence, digital health, clinical decision-support systems, medical imaging software, and other software-enabled technologies across healthcare settings.
• Germany, the United Kingdom, France, Italy, and Spain represent the major national markets within the region, supported by increasing healthcare digitization, government initiatives promoting digital health, investments in artificial intelligence and healthcare technology, and rising adoption of clinical software.
• The European Union has established regulatory frameworks for software-based medical technologies through the Medical Device Regulation, which provides requirements for the safety, performance, classification, and clinical evaluation of software used for medical purposes. In addition, initiatives supporting artificial intelligence, digital health, interoperability, and healthcare data infrastructure are contributing to the development and adoption of software as a medical device.
• The region’s well-developed healthcare infrastructure and strong emphasis on digital transformation facilitate the development, validation, commercialization, and adoption of software-based medical technologies.
• Europe also has a strong presence of medical technology, healthcare software, medical imaging, diagnostics, and digital health companies, supporting the development and deployment of AI-enabled diagnostic, monitoring, clinical decision-support, and therapeutic software solutions.
• In addition, increasing healthcare expenditure, the growing burden of chronic diseases, an aging population, and the need to improve healthcare efficiency are creating greater demand for digital and software-based healthcare solutions.
• The combination of regulatory maturity, advanced healthcare infrastructure, increasing digitalization, technological innovation, and growing adoption of clinical software is expected to support continued expansion of the European software as a medical device market throughout the forecast period.

Asia-Pacific

• Asia-Pacific is expected to record the fastest compound annual growth rate through 2034. 
• The region’s rapid market expansion is supported by its large and growing population, continued development of healthcare and digital infrastructure, increasing investment in artificial intelligence and digital health, and rising adoption of clinical software. 
• China, Japan, India, and South Korea represent the major national markets, driven by increasing healthcare spending, improvements in digital infrastructure, expansion of AI and digital health ecosystems, the growing prevalence of chronic diseases, and greater use of diagnostic and clinical software. 
• These developments are contributing to increased demand for software as a medical device (SaMD) across the region. As healthcare systems become more digitally enabled and AI, digital health solutions, and clinical software continue to advance, the region is expanding adoption from a growing base. 
• In addition, its large population and rapidly developing digital health ecosystem provide significant long-term opportunities for market growth. 
• The combination of population scale, infrastructure development, technological advancement, and increasing software adoption is expected to sustain Asia-Pacific’s position as the fastest-growing regional market and attract continued investment and commercial activity from leading global and regional companies.

To know more about why North America is leading market growth in the software as a medical device market, get a snapshot of the SaMD Development Firms AI Diagnostics

Recent Developmental Activities in the Software as a Medical Device Market

• In September 2026, the U.S. FDA updated its information on Artificial Intelligence-Enabled Medical Devices, highlighting the growing number of AI-enabled products that have undergone applicable premarket review.
• In June 2026, the FDA issued classifications involving radiological machine-learning quantitative imaging software with a predetermined change control plan, providing a regulatory pathway for certain software that can undergo specified future modifications without requiring a completely new submission for every change.
• In May 2026, FDA records show additional AI-enabled products receiving authorization in May 2026, including ZEUS Platform, MammoSightAI, ArteraAI Breast, and Lumify Diagnostic Ultrasound System, further expanding the range of AI-supported clinical software entering the U.S. medical-device market.

What is Software as a Medical Device?

Software as a Medical Device (SaMD) refers to software intended to perform one or more medical functions without being part of a physical medical device. Unlike software that primarily controls or operates medical hardware, SaMD can independently support the diagnosis, monitoring, prediction, prevention, or treatment of diseases and medical conditions. Examples include software that analyzes medical images to detect abnormalities, applications that interpret physiological data to identify health risks, and clinical decision-support tools that assist healthcare professionals in making diagnostic or treatment decisions. SaMD is increasingly being integrated with artificial intelligence, machine learning, cloud computing, and digital health platforms, enabling more personalized, data-driven, and accessible healthcare. Depending on its intended use and associated risks, SaMD may be subject to regulatory requirements related to clinical evidence, software validation, cybersecurity, quality management, and post-market surveillance.

Software as a Medical Device Market Report Metrics	Details
Coverage	Global
Study Period	2023–2034
Software as a Medical Device Market CAGR	~17%
Software as a Medical Device Market Size by 2034	USD 8.9 Billion
Key Software as a Medical Device Companies	Koninklijke Philips N.V., Siemens Healthineers AG, GE HealthCare Technologies Inc., Medtronic plc, and Aidoc Medical Ltd., alongside Viz.ai, Inc., Digital Diagnostics Inc., HeartFlow, Inc., Cognoa, Inc., Huma Therapeutics Limited, and others

Software as a Medical Device Market Assessment

• Software as a Medical Device Market Segmentation
  • Software as a Medical Device Market Segmentation By Biomarker Type: Diagnostic and Screening Software, Clinical Decision Support Software, Digital Therapeutics, and Monitoring and Treatment Planning Software
  • Software as a Medical Device Market Segmentation By Application: Radiology and Medical Imaging, Cardiology, Neurology, Ophthalmology, and Others
  • Software as a Medical Device Market Segmentation By Deployment: Cloud-based and On-Premise and Embedded
  • Software as a Medical Device Market Segmentation By End Users: Hospitals, Patients and Consumers, Diagnostic and Imaging Centers, and Others
  • Software as a Medical Device Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World
• Porter’s Five Forces Analysis, Product Profiles, Case Studies, KOL’s Views, Analyst’s View

Which MedTech key players in the software as a medical device market are set to emerge as the trendsetter explore @ Software as a Medical Device Market Analysis

Table of Contents 

1	Software as a Medical Device Market Report Introduction
2	Software as a Medical Device Market Executive Summary
3	Software as a Medical Device Market Key Factors Analysis
4	Impact Analysis
5	Regulatory Analysis
6	Software as a Medical Device Market Porter’s Five Forces Analysis
7	Software as a Medical Device Market Assessment
8	Competitive Landscape
9	Startup Funding & Investment Trends
10	Software as a Medical Device Market Company and Product Profiles
11	KOL Views
12	Project Approach
13	About DelveInsight
14	Disclaimer & Contact Us

Interested in knowing the SaMD market share by 2034? Click to get a snapshot of the Top Software as a Medical Device Companies

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