Software as a Medical Device (SaMD) Market Size, Share and Trend Analysis, By Type (Standalone Software, Mobile Apps, Web-based Platforms and Wearables), By Deployment (Cloud-based, On-Premise, Hybrid), By Technology, By Application, By End-Use and By Region, Forecast 2025-2032

Software as a Medical Device (SaMD) Market Overview and Key Insights:

The global Software as a Medical Device (SaMD) market size reached USD 2,048.8 Million in 2024 and is expected to register a revenue CAGR of 17.2 % during the forecast period. Rising prevalence of chronic diseases is a major factor driving the market revenue growth. Software as a Medical Device (SaMD) provides real-time health insights of chronic diseases treatments which allows healthcare professionals and patients to take informed decisions.

SaMD enables seamless data integration and remote monitoring of chronic diseases management, such as continuous glucose monitoring (CGM) and cardiovascular health monitoring. According to the World Health Organization (WHO), diabetes affects over 800 million adults worldwide, while cardiovascular disease (CVD) remains the leading cause of mortality, claiming an estimated 17.9 million lives annually.

Market Drivers:

Rapid deployment of software as a medical device (SaMD) in point-of-care (PoC) diagnosis further contributed in market revenue expansion. Hospitals, clinics and healthcare professionals are deploying SaMD to access and analyze patient’s medical history and recent lab results efficiently. Point-of-care (PoC) solutions such as electronic health records (EHRs) are digital toolkit for delivering critical information of patients.

The internet connectivity has significantly propelled the expansion of connected point-of-care (PoC), particularly for in-vitro diagnostics (IVD) tests. According to the International Telecommunication Union (ITU), 67% of the global population, equivalent to 5.4 billion people, is now online. This is a 4.7% increase since 2022, which is significant when compared to the 3.5% increase recorded between 2021 and 2022.

Earlier In-vitro diagnostics (IVD) tests were performed exclusively at laboratories which are now increasingly being performed at the point-of-care (PoC), at home, or via over-the-counter devices. Also, the usage of cloud-based platforms allows this data to be collected, analyzed, and shared in real-time with healthcare providers and patients.

Market Opportunity:

Advancements in 5G, along with the growing demand for artificial intelligence (AI) and machine learning (ML) driven diagnostic solutions, are expected to drive the revenue growth of the Software as a Medical Device (SaMD) market. According to the GSM Association, global 5G connections are expected to surpass 2 billion by 2025. The 5G network enables the full potential of the Internet of Medical Things (IoMT), which helps in facilitating real-time patient data exchange. Moreover, 5G is crucial for bandwidth-intensive medical applications, such as Cardiac Implantable Electronic Devices (CIED).

Federal agencies such as the United States Food and Drug Administration (FDA), European Medical Association (EMA) have established clear frameworks for AI and ML integration across healthcare platforms, which are expected to propel growth over the projected period. For instance, the U.S. FDA has established the AI/ML SaMD Action Plan and the European Union (EU) has established the AI Act. These developments are accelerating continuous innovations in generative AI in drug discovery, personalized healthcare, predictive analytics, and early disease detection.

Recent Trends:

Digital Therapeutics (DTx) is emerging as a key industry trend in Software as a Medical Device (SaMD) Market. Digital Therapeutics (DTx) is highly useful in the treatment of evidence-based health problems such as chronic diseases and mental health disorders. According to the World Health Organization (WHO), depression and anxiety cost the world economy USD 1 trillion each year. Poor mental health can result in lower performance, absences from work, and higher staff turnover, as a result, the importance of Digital Therapeutics (DTx) is rising exponentially across various sectors.

FDA Approvals:

In 2024, the U.S. FDA granted marketing clearance to several key players in the Software as a Medical Device (SaMD) market, which contributed to market revenue expansion in 2024. For instance, in January 2024, Nanowear Inc. received FDA 510(k) clearance for its innovative AI-driven Software-as-a-Medical Device (SaMD). In addition, In June 2024, AgileMD, Inc. received marketing clearance from the U.S. FDA for its machine learning (ML) powered software as a medical device (SaMD).

Restraints & Challenges:

Deployment of software as a medical device (SaMD) requires clearance such as 510(k), IEC 62304, ISO 13485, ISO 14971 by the regulatory authorities such as the U.S. Food and Drug Administration (FDA), International Medical Device Regulators Forum (IMDRF) and the European Medicines Agency (EMA). Delays in the approval from regulators can delay product deployment, which may limit the revenue growth of market.

Concerns regarding data security are also expected to hinder market revenue growth. Deployment of software relies heavily on vast amounts of data to generate results of diagnosis. Breach of individual and patients’ healthcare data may affect the reputation of companies. According to the FBI, the Internet Crime Complaint Centre (IC3) received 1,193 complaints from organizations within critical infrastructure sectors impacted by ransomware attacks.

Type Segment Insights and Analysis:

Based on the type, the Software as a Medical Device (SaMD) market is segmented into standalone software, mobile apps, web-based platforms, and wearables.

The mobile apps segment is expected to register the fastest revenue growth over the forecast period. Mobile applications are increasingly being used by individual users to track key metrics such as heart rate, blood pressure, glucose levels, and physical activity. According to research, in 2024, there were around 4.88 billion smartphone users globally, representing approximately 60.42% of the world’s population. This empowers individuals to take control of their health while enabling healthcare providers to monitor patients remotely.

Mobile applications are transforming healthcare delivery by providing individual patients with personalized support, real-time tracking, and therapeutic interventions through mobile devices. Additionally, FDA approval is expected to further accelerate the growth of the segment. For instance, On January 27^th, 2025, PanopticAI secured 510(k) clearance from the US Food and Drug Administration (FDA) for its contactless vital signs monitoring software.

Application Segment Insights and Analysis:

Based on the application, the Software as a Medical Device (SaMD) Market is segmented into diagnosis & screening, monitoring & disease management, therapeutic applications, remote patient monitoring (rpm) & telehealth, and others.

The diagnosis & screening segment contributed the largest revenue share in 2024. SaMD applications are designed for diagnosis and screening, without being part of a physical medical device. These software solutions help healthcare professionals make informed decisions by analyzing large volumes of data and advanced algorithms.

In addition, new approval of products in the diagnosis and screening segment significantly contributed to revenue growth in 2024. In October 2025, AccurKardia received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for Aortic Valve Stenosis (AVS) ECG-based AI screening software.

The diagnosis & screening segment will be further sub-segmented into the areas of radiology & imaging analysis, pathology & laboratory analysis, genetic testing & molecular diagnostics.

End-Use Segment Insights and Analysis:

Based on the end-use, the Software as a Medical Device (SaMD) Market is segmented into hospitals & clinics, diagnostic imaging centers, homecare settings, research institutions & universities, pharmaceutical & biotechnology companies, and individuals.

The hospitals & clinics segment contributed a significant revenue share in 2024. Hospitals and clinics highly rely on software as a medical device (SaMD) to continuously monitor and evaluate data of hospitalized patients. SaMD solutions are highly adopted in hospitals and clinics for performing critical tasks such as patient monitoring, diagnostic decision support, chronic disease management, and remote patient care. Furthermore, SaMD applications offer real-time access to patient data to facilitate quicker decision-making and better patient outcomes.

Geographical Outlook:

Software as a Medical Device (SaMD) Market is strategically segmented by geography to provide a comprehensive understanding of regional market dynamics. Discover demand analysis, emerging trends, and growth opportunities shaping market performance across different regions and countries.

North America Software as a Medical Device (SaMD) Market:

North America registered highest market share in the Software as a Medical Device (SaMD) Market. Rising incidence of chronic illnesses is driving market revenue growth in this region. Software as a Medical Device (SaMD) is highly adopted for treatment of chronic diseases by analyzing various data points collected from electronic health records (EHR).

According to research conducted by the Centres for condition Control and Prevention (CDC) of the United States Department of Health and Human Services, roughly 129 million Americans suffer from at least one severe chronic condition, such as heart disease, cancer, diabetes, obesity, or hypertension.

Incorporation of artificial (AI) and machine learning (ML) based software continues to contribute to market revenue growth in 2024. In December 2023, The United States Food and Drug Administration (FDA) cleared 700 AI healthcare algorithms, with over 76% focused on radiology.

Asia Pacific Software as a Medical Device (SaMD) Market:

Asia Pacific is expected to register fastest revenue growth by 2032. Rising adoption of Software as a Medical Device (SaMD) for treatment of cardiovascular diseases across countries in Asia Pacific contributed to revenue expansion in this region. A significant number of patients and healthcare providers are using wearable and heart monitoring device to monitor and access real-time data, this as a result are driving demand strategically. According to the World Health Organization (WHO), cardiovascular diseases cause 3.9 million deaths annually in the WHO South-East Asia Region.

Advancement in artificial intelligence (AI) and machine learning (ML) accelerated new innovations which are further contributing growth of the market. Competitors across this region are innovating AI-powered tool for monitor and diagnosis of diseases. On January 2025, South Korea based Monitor Corporation launched lung cancer diagnosis software in Japan through a partnership with Doctor-NET, a Japanese digital healthcare provider.

Also, the rapid deployment 5G network in this region is expected to propel revenue growth of cloud-based software as a medical device (SaMD) over the projected period. Healthcare providers this region are adopting cloud-based SaMD to access and analyze patient data seamlessly. The GSM Association projected by 2030, 5G will represent over 41% of mobile connections in the Asia-Pacific (APAC) region, a significant increase from 4% in 2022.

Europe Software as a Medical Device (SaMD) Market:

Europe contributed a substantial revenue share in 2024. Government support in AI innovation and research funding is a key factor fueling revenue growth in this region. In January 2024, The European Union (EU), commissioned AI innovation pregame GenAI4EU with an investment of USD 4.35 billion (EUR 4 billion) for the 2024-2027 period. The GenAI4EU focused on advancing novel use cases and emerging applications include healthcare, biotechnology, and virtual environments.

Moreover, the growing elderly population in Europe is expected to boost market revenue growth over the forecast period. According to the European Union (EU), the EU population was predicted to reach 448.8 million on January 1, 2023, with more than one-fifth (21.3%) of the population aged 65 and up. Chronic illnesses are more common among the elderly, and deployment of SaMD for the prediction and diagnosis of chronic diseases is growing substantially.

Competition Analysis:

The Software as a Medical Device (SaMD) market is characterized by a fragmented structure, with major players competing across various segments and regions. The list of major players included in the Software as a Medical Device (SaMD) market report are:

• Medtronic PLC
• GE HealthCare
• Samsung Medison Co., Ltd.
• Click Therapeutics, Inc.
• Median Technologies SA
• Capgemini SE
• Hyperfine, Inc.
• Medisafe
• BioT Healthcare Ltd.
• VUNO Inc
• Siemens AG
• Koninklijke Philips N.V.
• Monitor corporation
• WellSky Corporation
• PanopticAl Ltd.
• AccurKardia, Inc.
• Nanowear Inc.
• AgileMD, Inc.

Strategic Developments in Software as a Medical Device (SaMD) Market:

• On February 3^rd 2025, Median Technologies successfully completed the clinical validation of its eyonis lung cancer screening (LCS) diagnostic, achieving the primary endpoint in a second pivotal study. This accomplishment sets the stage for forthcoming regulatory clearance submissions in the United States and the European Union (EU).
• On October 25^th 2024, WellSky Corporation completed the acquisition of Bonafide. This acquisition enables WellSky to expand its presence in the DME/HME sector, offering an integrated software platform that supports providers in managing their operations in a compliant, efficient, and profitable manner.
• On 30^th October 2024, Click Therapeutics, Inc. launched a Software-Enhanced Drug Therapies product Click SE. This software will address the growing interest in the U.S. Food and Drug Administration (FDA) draft guidance on Prescription Drug-Use Related Software (PDURS).

Key Advantages for Stakeholders:

Navistrat Analytics’ industry report provides an in-depth quantitative analysis of various market segments, historical and current trends, market forecasts, and dynamics within the global market. The historical years covered in this report are 2022 to 2023, with 2024 serving as the base year for market size calculations. The forecast period extends from 2025 to 2032.

The report includes an executive summary and a comprehensive overview of market drivers, restraints, opportunities, and challenges (DROC), along with insights into regulatory standards. It features detailed analyses such as PORTER’s Five Forces, SWOT, and PESTLE, as well as assessments of technological trends and the competitive landscape.

PORTER’s Five Forces analysis helps stakeholders evaluate the impact of new entrants, competitive rivalry, supplier power, buyer power, and substitution threats, enabling them to assess the level of competition and the attractiveness of the global market. The competitive landscape provides stakeholders with a clear understanding of the current market positions of key players, offering valuable insights into their competitive environment.

Scope And Key Highlights of The Software as a Medical Device (SaMD) Market Report:

The Software as a Medical Device (SaMD) Market report offers a detailed analysis of market size, including historical revenue (in USD Million) data for 2022-2023 and revenue forecasts for 2025-2032 across the following segments:

• Type Outlook (Revenue, USD Million; 2022-2032)
  • Standalone Software
  • Mobile Apps
  • Web-based Platforms
  • Wearables

• Deployment Outlook (Revenue, USD Million; 2022-2032)
  • Cloud-based
  • On-Premise
  • Hybrid

• Technology Outlook (Revenue, USD Million; 2022-2032)
  • Artificial Intelligence & Machine Learning (AI/ML)
  • Internet of Medical Things (IoMT)
  • Big Data Analytics
  • Blockchain
  • Others

• Application Outlook (Revenue, USD Million; 2022-2032)
  • Diagnosis & Screening
    • Radiology & Imaging Analysis
    • Pathology & Laboratory Analysis
    • Genetic Testing & Molecular Diagnostics
  • Monitoring & Disease Management
    • Chronic Disease Monitoring
    • Neurological Disorders Monitoring
    • Respiratory Monitoring
  • Therapeutic Applications
    • Pain Management Software
    • Virtual Rehabilitation & Physical Therapy
  • Remote Patient Monitoring (RPM) & Telehealth
    • Wearable-connected Health Platforms
    • Telemedicine Software
    • Home-based Patient Monitoring
  • Others

• End-Use Outlook (Revenue, USD Million; 2022-2032)
  • Hospitals & Clinics
  • Diagnostic Imaging Centers
  • Homecare Settings
  • Research Institutions & Universities
  • Pharmaceutical & Biotechnology Companies
  • Individuals

• Regional Outlook (Revenue, USD Million; 2022-2032)
  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • U.K.
    • Italy
    • Spain
    • Benelux
    • Nordic Countries
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Oceania
    • ASEAN Countries
    • Rest of APAC
  • Latin America
    • Brazil
    • Rest of LATAM
  • Middle East & Africa
    • GCC Countries
    • South Africa
    • Israel
    • Turkey
    • Rest of MEA

Frequently Asked Questions (FAQ) About the Software as a Medical Device (SaMD) Market Report