Software as a Medical Device (SaMD) Market Size to Reach USD 7,125.7 Million in 2032

17 April 2025 – Rapid implementation of software as a medical device (SaMD) in point-of-care (PoC) diagnostics contributed to market revenue growth. Hospitals, clinics, and healthcare professionals use SaMD to seamlessly access and evaluate patients' medical histories and current test findings. Electronic health records (EHRs) and other point-of-care (PoC) systems serve as a digital toolset for delivering essential patient information.

SaMD allows seamless data integration and remote monitoring for chronic illness management, including continuous glucose monitoring (CGM) and cardiovascular health monitoring. Diabetes affects nearly 800 million individuals globally, According to the World Health Organization (WHO), cardiovascular disease (CVD) continues to be the leading cause of death, accounting for an estimated 17.9 million deaths each year.

Federal organizations such as the United States Food and Drug Administration (FDA) and the European Medical Association (EMA) have set defined guidelines for AI and machine learning integration across healthcare platforms, which are predicted to drive growth over the projected timeframe. For example, the US FDA has produced the AI/ML SaMD Action Plan, while the European Union (EU) has established the AI Act.

In 2024, the US FDA gave marketing authorization to several major players in the Software as a Medical Device (SaMD) market, contributing to market revenue growth in 2024. For example, Nanowear Inc. gained FDA 510(k) approval in January 2024 for its breakthrough AI-driven Software-as-a-Medical Device (SaMD).

Concerns over data security are also predicted to hinder market revenue growth. Software deployment is largely reliant on large volumes of data to produce diagnostic results. The breach of individual and patient healthcare data may have an impact on a company's reputation which can adversely impact to the market revenue growth,

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Segments market overview and growth Insights:

The mobile apps segment is expected to register the fastest revenue growth over the forecast period. Individual users are increasingly using mobile applications to measure daily health activity including heart rate, blood pressure, glucose levels, and physical activity. According to estimates, there will be over 4.88 billion smartphone users worldwide in 2024, accounting for around 60.42% of the global population.

The hospitals & clinics segment contributed a significant revenue share in 2024. Hospitals and clinics rely extensively on software as a medical device (SaMD) to constantly monitor and assess data from hospitalized patients. SaMD systems are widely used in hospitals and clinics to provide key functions such as patient monitoring, diagnostic decision support, chronic illness management, and remote patient care.

Regional market overview and growth insights:

North America registered the highest market share in the Software as a Medical Device (SaMD) Market. Rising prevalence of chronic diseases is fueling market revenue growth in this region. Software as a Medical Device (SaMD) is widely used to treat chronic illnesses by evaluating numerous data points obtained from electronic health records.

Advancements in artificial intelligence (AI) and machine learning (ML) accelerating market's growth in Asia Pacific. Competitors in this region are developing AI-powered tools for monitoring and diagnosing ailments. Monitor Corporation, located in South Korea, debuted lung cancer diagnostic software in Japan in January 2025 as part of a relationship with Doctor-NET, a Japanese digital healthcare service.

Competitive Landscape and Key Competitors:

The Software as a Medical Device (SaMD) Market is characterized by a fragmented structure, with many competitors holding a significant share of the market. 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.

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Major strategic developments by leading competitors

Click Therapeutics, Inc. : On 30^th October 2024, Click Therapeutics, Inc. has introduced a Software-Enhanced Drug Therapies solution called Click SE. This program will respond to the increased interest in the US Food and Drug Administration's (FDA) proposed advice on Prescription Drug-Use Related program.

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Navistrat Analytics has segmented Software as a Medical Device (SaMD) Market on the basis of type, deployment, technology, application, end-use and region:

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

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

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

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

• Regional Outlook (Revenue, USD Billion; 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
    • Taiwan
    • Oceania
    • ASEAN Countries
    • Rest of APAC
  • Latin America
    • Brazil
    • Rest of LATAM
  • Middle East & Africa
    • GCC Countries
    • South Africa
    • Israel
    • Turkey
    • Rest of MEA

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