Software as a Medical Device (SaMD) Market Size & Share 2026-2035

Software as a Medical Device (SaMD) Market Size

The global software as a medical device (SaMD) market was valued at USD 5.8 billion in 2025 and is projected to grow from USD 6.5 billion in 2026 to USD 21.1 billion by 2035, expanding at a CAGR of 13.9%, according to the latest report published by Global Market Insights Inc. The steady growth of the market is driven by the expansion of remote patient monitoring reimbursement codes, regulatory support for digital therapeutics and software-based solutions, rising adoption of digital health technologies and AI-powered diagnostic SaMD demonstrating superior clinical sensitivity in comparison with traditional methods, among other factors.

Advancements in artificial intelligence and machine learning, penetration into emerging healthcare markets, and development of software for mental health management are among the key factors propelling the industry’s growth. The major players in the global market are GE HealthCare, Siemens Healthineers, Koninklijke Philips, iRhythm Technologies, and Tempus AI. These companies maintain their competitive position through consistent innovation, investment in R&D activities, global market presence, and collaboration with healthcare facilities, among others.

The market increased from USD 3.9 billion in 2022 to USD 5 billion in 2024, registering a historical growth rate of 12.3%. The increasing adoption of digital health technologies is a major driver for the software as a medical device market because healthcare providers are rapidly incorporating software-based solutions into diagnosis, treatment, monitoring, and patient engagement workflows. The widespread use of electronic health records, mobile health applications, connected medical devices, and cloud-based healthcare platforms has created a favorable environment for SaMD deployment. These solutions improve clinical efficiency, support data-driven decision-making, and enable real-time access to patient information.

Additionally, artificial intelligence-enabled diagnostic SaMD solutions are gaining traction because they can identify subtle patterns and abnormalities that may be difficult to detect through conventional diagnostic approaches. Enhanced clinical sensitivity can support earlier disease detection, faster diagnosis, and more consistent interpretation of medical data such as imaging, cardiac signals, and pathology results. Healthcare providers increasingly recognize the value of AI-assisted decision support tools in reducing diagnostic variability and improving workflow efficiency. As clinical evidence continues to validate the performance of these solutions across multiple therapeutic areas, healthcare organizations are adopting AI-powered SaMD to improve patient outcomes, creating substantial growth opportunities for the market.

Software as a Medical Device (SaMD) refers to software intended for medical purposes, such as diagnosis, monitoring, prevention, prediction, or treatment of diseases, that performs these functions independently of a dedicated hardware medical device while supporting clinical decision-making and patient care.

Software as a Medical Device (SaMD) Market Trends

Growth of digital therapeutics, shift toward personalized and predictive healthcare, greater integration with healthcare data ecosystems, and AI-enabled clinical decision support and diagnostics are among the key trends shaping the market growth in an upward trajectory.

• SaMD developers are increasingly focusing on interoperability and integration with electronic health records, connected devices, and hospital information systems. Seamless data exchange allows healthcare professionals to access comprehensive patient information through unified platforms, improving care coordination, clinical decision-making, and operational efficiency while supporting broader software adoption.
• Additionally, artificial intelligence is becoming a defining trend in the SaMD market as healthcare providers increasingly adopt software capable of analyzing medical images, physiological signals, and patient records. AI-powered solutions help improve diagnostic consistency, support earlier disease detection, and enhance clinical workflows, encouraging wider adoption of software-based medical tools across healthcare settings.
• Moreover, healthcare organizations are increasingly leveraging SaMD solutions to support personalized medicine and predictive care strategies. Advanced analytics and patient-specific insights enable tailored treatment recommendations and proactive disease management. This trend is strengthening demand for software platforms capable of transforming large volumes of health data into actionable clinical intelligence, thereby fueling market growth.

Software as a Medical Device (SaMD) Market Analysis

Based on software type, the market is segmented into diagnostic and imaging software, clinical decision support (CDS) software, remote patient monitoring (RPM) software, digital therapeutics (DTx), surgical planning and navigation software, and other software types. The clinical decision support (CDS) software segment held a leading software as a medical device market share and was valued at USD 2 billion in 2025.

• Clinical decision support software is gaining significant traction as healthcare organizations seek tools that enhance diagnostic accuracy and treatment planning. These solutions analyze patient information, clinical guidelines, laboratory results, and historical data to provide evidence-based recommendations to clinicians.
• CDS software helps reduce medical errors, improve workflow efficiency, and support standardized clinical practices.
• Additionally, growing healthcare data volumes and increasing emphasis on personalized medicine are driving demand for advanced decision-support capabilities.
• Further, the integration of artificial intelligence is further strengthening the value proposition of CDS platforms by enabling predictive analytics and real-time insights that support better patient outcomes.
• The diagnostic and imaging software segment accounted for USD 1.6 billion in 2025. Diagnostic and imaging software represents one of the largest segments of the SaMD market, supporting disease detection, image interpretation, and clinical assessments.
• These solutions analyze data from modalities such as MRI, CT, X-ray, ultrasound, and pathology systems to assist healthcare professionals in identifying abnormalities with greater speed and accuracy.
• In addition, increasing adoption of artificial intelligence and machine learning algorithms is further enhancing image analysis capabilities and reducing diagnostic variability.
• The remote patient monitoring (RPM) software segment accounted for USD 756.4 million in 2025 and is projected to grow at a robust CAGR over the forecast period. Remote patient monitoring software is experiencing strong growth due to increasing demand for continuous patient management outside traditional healthcare facilities.
• These platforms collect, analyze, and transmit health data from connected devices, wearables, and home-based monitoring systems.
• Furthermore, RPM software supports chronic disease management, post-discharge care, and preventive healthcare by enabling real-time monitoring and timely clinical intervention.
• Moreover, the growing shift toward home-based care, coupled with advancements in connected health technologies, continues to strengthen adoption of RPM software across diverse healthcare environments.

Based on deployment mode, the software as a medical device market is segmented into cloud-based and on-premise. The cloud-based segment is projected to expand at 14.3% CAGR to reach USD 14.1 billion by 2035.

• Cloud-based SaMD solutions are witnessing rapid adoption due to their scalability, flexibility, and ability to facilitate real-time data access. Healthcare providers increasingly prefer cloud deployment because it enables efficient data storage, remote accessibility, seamless software updates, and integration across multiple healthcare locations.
• Cloud platforms also support advanced analytics, artificial intelligence applications, and collaborative care models by allowing secure access to large healthcare datasets.
• Further, as healthcare organizations continue digital transformation initiatives, demand for cloud-based SaMD solutions is rising.
• Additionally, the deployment model is particularly attractive for healthcare systems seeking cost-effective and scalable software infrastructure without extensive hardware investments.
• The on-premise segment is projected to expand at a 13.1% CAGR to reach USD 7 billion by 2035. On-premise SaMD deployment remains important among organizations prioritizing direct control over data management and security infrastructure.
• Hospitals and healthcare institutions with strict compliance requirements often prefer on-premise installations to maintain oversight of sensitive patient information and internal IT environments.
• Additionally, these solutions can provide greater customization and integration with existing healthcare systems, making them suitable for complex clinical settings.
• Furthermore, demand remains supported by healthcare providers seeking enhanced system control and localized data storage capabilities.

Based on the IMDRF risk category, the SaMD market is segmented into category I, category II, category III, and category IV. The category II segment is projected to expand at a 13.7% CAGR to reach USD 9.4 billion by 2035.

• Category II SaMD solutions generally represent moderate-risk software applications where incorrect outputs may influence healthcare management but are unlikely to result in severe patient harm under normal circumstances. These software products are commonly used for monitoring, clinical assessments, and supporting treatment decisions.
• Regulatory requirements for category II products emphasize safety, performance, and clinical validation to ensure reliable operation.
• Additionally, growing adoption of digital health tools and disease management platforms is contributing to increased utilization of this category.
• The category III segment is projected to expand at a notable growth to reach USD 6.3 billion by 2035. Category III SaMD solutions are associated with higher clinical significance because they influence critical healthcare decisions that can directly impact patient diagnosis or treatment.
• Further, these products often involve advanced diagnostic algorithms, decision-support systems, and specialized disease management applications.
• In addition, due to their higher risk profile, category III solutions require extensive clinical validation, performance assessment, and regulatory scrutiny. Increasing reliance on artificial intelligence, precision medicine, and advanced analytics is driving demand for sophisticated software applications within this category.
• Furthermore, as healthcare providers seek more advanced diagnostic and therapeutic support capabilities, category III SaMD solutions continue to gain strategic importance.

Based on end use, the software as a medical device market is segmented into hospitals and clinics, diagnostic and radiology centers, home care settings, research and academic institutions, and other end users. The hospitals and clinics segment held a leading market share of 48.1% in 2025.

• Hospitals and clinics represent the largest end-use segment for SaMD solutions due to their extensive need for diagnostic, monitoring, and clinical decision-support applications.
• Healthcare providers utilize software-based tools to improve operational efficiency, support patient management, and enhance diagnostic accuracy.
• Additionally, rising patient volumes and increasing adoption of digital healthcare technologies are accelerating software integration into routine clinical workflows. In addition, hospitals implement AI-powered solutions, remote monitoring platforms, and analytics tools to optimize care delivery. Continued digital transformation initiatives and a growing focus on value-based healthcare are expected to sustain strong demand from this segment.
• The software as a medical device market from diagnostic and radiology centers segment is expected to show a robust growth rate of 14.4% through 2035. Diagnostic centers and radiology facilities are increasingly adopting SaMD solutions to improve imaging interpretation, workflow management, and diagnostic precision.
• Advanced software platforms help automate image analysis, streamline reporting processes, and support early disease detection. The growing volume of diagnostic imaging procedures is encouraging providers to implement AI-powered tools that enhance efficiency and reduce interpretation time.
• Further, these facilities also benefit from software solutions that facilitate image sharing, data management, and collaboration among healthcare professionals.
• The home care settings segment is projected to expand at a high growth rate to reach USD 3.3 billion by 2035. Home care settings are emerging as a significant end-use segment as healthcare systems increasingly shift toward patient-centered and remote care models.
• SaMD solutions used in home environments support continuous monitoring, chronic disease management, medication adherence, and virtual healthcare services.
• Additionally, integration with wearable devices and connected health technologies enables healthcare providers to track patient conditions in real time while reducing reliance on hospital visits.
• Furthermore, growing patient preference for convenient care, combined with advancements in remote monitoring capabilities, is driving adoption.

North America Software as a Medical Device (SaMD) Market

The North America region accounted for 40% of the market in 2025. The market is experiencing robust expansion, driven by the region’s advanced healthcare infrastructure, demand for personalized and data-driven treatment approaches, growing prevalence of chronic diseases, and integration with electronic health records (EHRs).

• The U.S. SaMD market was valued at USD 2.2 billion in 2025 from USD 1.9 billion in 2024.
• Healthcare providers across the U.S. and Canada are increasingly implementing AI-based diagnostic software, remote patient monitoring solutions, and digital therapeutics to improve care quality and operational efficiency.
• The region benefits from a well-established regulatory environment that supports innovation in software-based medical technologies.
• Additionally, growing demand for value-based healthcare, rising prevalence of chronic diseases, and increasing integration of connected medical devices are accelerating SaMD deployment.
• The continuous investments in artificial intelligence, cloud computing, and personalized healthcare solutions further strengthen regional market growth.

Europe Software as a Medical Device (SaMD) Market

Europe software as a medical device (SaMD) industry accounted for USD 1.6 billion in 2025 and is anticipated to show lucrative growth over the forecast period.

• The European SaMD market is growing steadily due to increasing digitalization of healthcare systems and expanding adoption of software-driven clinical decision support tools. Countries such as Germany, the UK, France, and the Nordic nations are actively promoting digital health initiatives to improve patient outcomes and healthcare efficiency.
• Growing use of AI-enabled diagnostics, remote monitoring platforms, and digital therapeutics is supporting market expansion across the region.
• Additionally, strong focus on interoperability, data-driven healthcare delivery, and cross-border digital health programs is encouraging broader adoption of SaMD solutions in both public and private healthcare settings.

Asia Pacific Software as a Medical Device (SaMD) Market

The Asia Pacific region is projected to show a lucrative growth of about 15.4% during the forecast period.

• Asia Pacific is emerging as the fastest-growing SaMD market, supported by rapid healthcare digitalization, expanding internet connectivity, and growing investments in healthcare technology. Countries such as China, Japan, South Korea, Australia, and India are increasingly adopting AI-powered diagnostic software, telehealth platforms, and remote patient monitoring solutions to address rising healthcare demands.
• Large patient populations and increasing prevalence of chronic diseases are creating significant opportunities for software-based healthcare innovations.
• In addition, governments across the region are also promoting digital health transformation through supportive policies and modernization initiatives.
• Furthermore, the growing presence of technology companies, increasing smartphone penetration, and expanding healthcare infrastructure are contributing to accelerated adoption of SaMD solutions.

Latin America Software as a Medical Device (SaMD) Market

Latin America is experiencing significant growth in the software as a medical device (SaMD) industry.

• The Latin American market is experiencing steady growth as healthcare systems increasingly adopt digital technologies to improve accessibility and efficiency.
• Countries including Brazil, Mexico, Argentina, and Chile are witnessing greater implementation of telemedicine, electronic health records, and software-based diagnostic solutions.
• Rising healthcare expenditure and increasing awareness of digital health benefits are encouraging healthcare providers to integrate SaMD into clinical workflows.
• Furthermore, the need to improve healthcare access in remote and underserved areas is further driving demand for remote monitoring and virtual care platforms.

Middle East and Africa Software as a Medical Device (SaMD) Market

• The Middle East & Africa SaMD industry is growing as governments and healthcare organizations accelerate digital transformation initiatives to strengthen healthcare delivery.
• Countries such as Saudi Arabia, the UAE, and South Africa are investing in advanced healthcare technologies, including AI-enabled diagnostics, telehealth platforms, and remote patient monitoring systems.
• Additionally, growing demand for efficient healthcare services, increasing chronic disease prevalence, and efforts to improve healthcare accessibility are supporting adoption of software-based medical solutions.

Software as a Medical Device (SaMD) Market Share

The software as a medical device industry is characterized by a highly competitive landscape comprising large medical technology companies, healthcare IT providers, specialized digital health firms, and emerging artificial intelligence innovators. Established players such as GE HealthCare, Siemens Healthineers, and Koninklijke Philips leverage their extensive healthcare infrastructure, imaging portfolios, and global customer networks to integrate advanced software solutions into clinical workflows. These companies focus on enhancing diagnostic accuracy, interoperability, and hospital operational efficiency through AI-enabled platforms and enterprise informatics solutions.

At the same time, specialized SaMD companies such as iRhythm have strengthened competition by developing disease-specific software platforms that address targeted clinical needs, particularly in areas such as cardiac monitoring and arrhythmia detection. Emerging technology-driven companies, including Tempus AI, are accelerating innovation through artificial intelligence, predictive analytics, and large-scale clinical data utilization to support precision medicine and personalized treatment decisions.

Additionally, competition in the market is increasingly centered on clinical validation, regulatory approvals, cybersecurity capabilities, and integration with electronic health records and connected medical devices. Strategic partnerships between software developers, healthcare providers, pharmaceutical companies, and device manufacturers have become a key differentiating factor.

Further, companies are investing heavily in cloud-based infrastructure, remote patient monitoring platforms, digital therapeutics, and AI-powered decision support tools. As healthcare systems continue to embrace digital transformation, innovation speed, real-world clinical evidence, and scalable software ecosystems remain critical factors influencing competitive positioning within the SaMD market.

Software as a Medical Device (SaMD) Market Companies

Few of the prominent players operating in the software as a medical device (SaMD) industry include:

• Aidoc Medical
• Brainlab AG
• Butterfly Network
• Canon Medical Systems
• Fujifilm Holdings
• GE HealthCare
• Huma Therapeutics
• iRhythm Technologies
• Koninklijke Philips
• Medtronic
• PathAI
• Qlarity Imaging
• Roche Diagnostics
• Siemens Healthineers
• Tempus AI
• Viz.ai

• GE HealthCare

GE HealthCare focuses on integrating AI-enabled software with its imaging and monitoring ecosystem, strengthening cloud-based healthcare platforms, expanding digital partnerships, and enhancing clinical decision support solutions to improve workflow efficiency and patient outcomes.

• iRhythm Technologies

iRhythm focuses on expanding adoption of its AI-based cardiac monitoring and arrhythmia detection solutions, generating robust clinical evidence, enhancing analytical capabilities, and increasing provider engagement to support broader utilization across cardiovascular care.

Software as a Medical Device (SaMD) Industry News

• In February 2026, Median Technologies announced a collaboration with Tempus AI to expand access to their eyonis LCS Software as a Medical Device in the U.S. Under the agreement, Tempus AI will distribute eyonis LCS to U.S. imaging providers through the Tempus Pixel platform and support implementation, customer onboarding, and workflow integration. This development may enable the company to expand its presence and boost its sales prospects in the country.
• In July 2025, iRhythm Technologies, Inc., a digital health company focused on creating trusted solutions that detect, predict, and prevent disease, announced a strategic partnership with Lucem Health, a key player in AI-driven early disease detection, to accelerate early identification of undiagnosed arrhythmias in patient populations with an elevated risk for arrhythmias. This strategic partnership, supported by iRhythm’s direct investment in Lucem Health, reflects a shared commitment to advancing predictive innovation for patients.

The software as a medical device market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million and from 2022 - 2035 for the following segments:

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Market, By Software Type

• Diagnostic and imaging software
• Clinical decision support (CDS) software
• Remote patient monitoring (RPM) software
• Digital therapeutics (DTx)
• Surgical planning and navigation software
• Other software types

Market, By Deployment Mode

• Cloud-based
• On-premise

Market, By IMDRF Risk Category

• Category I
• Category II
• Category III
• Category IV

Market, By End Use

• Hospitals and clinics
• Diagnostic centers and radiology
• Home care settings
• Research and academic institutions
• Other end users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Netherlands
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE