Software as a Medical Device (SaMD) Market Forecast Shows Robust Expansion at 13.6% CAGR Through 2033

Overview

New York, NY – Feb 03, 2026 –  The Global Software as a Medical Device (SaMD) Market size is expected to be worth around USD 5.0 Billion by 2033 from USD 1.4 Billion in 2023, growing at a CAGR of 13.6% during the forecast period from 2024 to 2033.

Software as a Medical Device (SaMD) refers to software intended to be used for one or more medical purposes without being part of a physical medical device. SaMD solutions are increasingly being adopted across healthcare systems to support diagnosis, disease monitoring, treatment planning, and clinical decision-making. The growing use of digital health technologies has positioned SaMD as a critical component of modern healthcare delivery.

SaMD products operate independently on general-purpose computing platforms such as smartphones, tablets, or cloud-based systems. These solutions are designed to analyze medical data, generate clinical insights, and improve healthcare efficiency while maintaining patient safety and data integrity. Typical applications include diagnostic imaging software, clinical decision support tools, digital therapeutics, and remote patient monitoring systems.

The development and commercialization of SaMD are governed by well-defined regulatory frameworks established by global health authorities. Regulatory bodies emphasize a risk-based approach, focusing on intended use, clinical impact, and patient safety. Key requirements generally include software lifecycle management, clinical evaluation, cybersecurity controls, and post-market performance monitoring.

The increasing demand for personalized medicine, remote healthcare delivery, and data-driven clinical insights is expected to support steady growth of the SaMD segment. Continuous advancements in artificial intelligence, machine learning, and cloud computing are further strengthening innovation in this space.

Overall, Software as a Medical Device represents a transformative shift in healthcare, enabling scalable, efficient, and patient-centric medical solutions while adhering to rigorous regulatory and quality standards.

Key Takeaways

• Market Size: The Software as a Medical Device (SaMD) market is projected to reach approximately USD 5.0 billion by 2033, increasing from an estimated USD 1.4 billion in 2023.
• Market Growth: Market expansion is expected to occur at a compound annual growth rate (CAGR) of 13.6% during the forecast period from 2024 to 2033.
• Device Type Analysis: In 2023, laptops and desktops represented the leading device category in the SaMD market, accounting for nearly 52% of the total market share.
• Application Analysis: Screening and diagnostic applications emerged as the largest application segment in 2023, contributing around 38% of the overall SaMD market share.
• Regional Analysis: North America maintained its dominant position in 2023, capturing approximately 36% of the global Software as a Medical Device market.
• Growth Opportunities: Increasing adoption of SaMD solutions for chronic disease management and telemedicine is creating significant growth opportunities by enabling scalable and cost-efficient healthcare delivery models.
• Regulatory Environment: Emphasis on regulatory compliance and quality standards remains critical, as regulatory authorities continue to evolve frameworks to address the specific requirements of digital health technologies.

Regional Analysis

In 2023, North America held a leading position in the Software as a Medical Device (SaMD) market, accounting for approximately 36% of global revenue. This leadership is primarily supported by the region’s well-established healthcare infrastructure and early adoption of digital health solutions.

Supportive regulatory frameworks, along with strong public and private investment in healthcare innovation, have further reinforced market expansion across the region. Europe represents the second-largest market, benefiting from ongoing healthcare system modernization and regulatory initiatives that encourage the integration of digital health technologies.

The Asia-Pacific region is witnessing accelerated market growth, driven by rising healthcare needs, expanding patient populations, and continuous technological advancements. Countries within the region are increasingly adopting SaMD solutions to enhance healthcare accessibility and efficiency. Meanwhile, emerging markets in Latin America and Africa are demonstrating growing potential, supported by improving digital infrastructure and increasing awareness of digital health solutions.

Emerging trends in Software as a Medical Device (SaMD)

Fast growth of AI-based SaMD (especially imaging and decision support)

• The number of AI/ML-enabled medical devices being cleared/approved has become very large; one peer-reviewed analysis reported 1,016 AI/ML devices cleared/approved by the U.S. Food and Drug Administration as of December 2024, with 572 cleared/approved since 2021.
• This growth is being reinforced by the FDA’s maintained AI-enabled medical device list that is updated over time and provides downloadable device records.

More reliance on “real-world” performance data, not only premarket trials

• A new FDA pilot (TEMPO) is being used to test a more flexible, risk-based approach where real-world data collection is expected while devices are used under defined conditions.
• Participation is planned to be limited to up to ~10 manufacturers in each of 4 clinical use areas (so ~40 manufacturers at maximum, if fully filled).

Cybersecurity is becoming a “must-have” requirement for SaMD and connected software

• FDA final guidance (June 2025) has been positioned to strengthen cybersecurity expectations in premarket submissions and aligns to statutory requirements for “cyber devices.”
• In practical terms, cybersecurity evidence is increasingly treated like safety evidence, and software documentation is being demanded earlier and in more detail for internet-connectable products.

Higher evidence expectations (clinical + economic), pushed by health systems

• The National Institute for Health and Care Excellence evidence standards framework describes 21 standards arranged in 5 groups for digital health technologies used in care pathways, which is shaping how SaMD developers plan validation and outcomes evidence.
• This is leading to more SaMD programs being designed to show measurable outcomes and value for money, not only usability or engagement.

More SaMD being treated like “therapy,” not only like “tools”

• Prescription digital therapeutics (a SaMD subset) are being identified and tracked in peer-reviewed healthcare literature; one 2025 review identified 13 prescription digital therapeutics, with 61.5% cleared via 510(k) and 38.5% via De Novo pathways.
• Clinical validation activity is also expanding: a 2024 analysis identified 449 digital therapeutics clinical trials on ClinicalTrials.gov (2010–2030 window) using structured search terms.

Use Cases

Radiology and imaging triage

• This is one of the most common real-world uses of AI-based SaMD, supported by the large scale of FDA-cleared/approved AI/ML devices (1,016 as of Dec 2024).
• Value is typically delivered by prioritizing urgent findings and standardizing measurements to reduce reporting variation.

Chronic disease management software used alongside outpatient care

• FDA’s TEMPO pilot is targeted toward technology-enabled chronic care and is structured around 4 clinical use areas (as listed in the Federal Register notice and FDA communications), with participation limited to ~10 manufacturers per area.
• This signals strong demand for SaMD that can show measurable changes in outcomes for long-duration conditions (for example, cardio-metabolic and behavioral health pathways).

Prescription digital therapeutics for mental health, neurology, and cardiometabolic conditions

• Prescription digital therapeutics have been documented in the medical literature as FDA-cleared/authorized products (example count: 13 identified in one review).
• Deployment is usually as “adjunct therapy” (used with standard care), where adherence and symptom tracking are part of the therapeutic effect measurement.

Remote monitoring + algorithmic alerts for earlier clinical action

• SaMD is widely used to turn continuous or frequent measurements into alerts and risk scores, which supports earlier intervention and reduced delays. This use case is closely linked to the FDA’s focus on real-world performance measurement in modern digital programs.
• The scale of the clinical research ecosystem also supports this direction: ClinicalTrials.gov lists 568,949 studies overall (all therapeutic areas), showing the large infrastructure available to test software-supported monitoring approaches.

Digitized health system workflows (patient follow-up, adherence support, and guideline-driven care)

• The World Health Organization guideline on digital interventions (2019) reflects how software tools are being positioned to strengthen health systems, including patient communications and service delivery support.
• This direction is reinforced by WHO’s broader global strategy work on digital health, which frames digital tools as system enablers rather than optional add-ons.

Conclusion

Software as a Medical Device (SaMD) is becoming a foundational element of modern healthcare delivery, driven by the need for scalable, data-driven, and patient-centric solutions. Market growth is being supported by expanding use cases across diagnostics, chronic disease management, digital therapeutics, and remote monitoring.

Regulatory frameworks are evolving toward risk-based oversight with stronger emphasis on real-world evidence, cybersecurity, and measurable clinical and economic outcomes. Advances in artificial intelligence and cloud technologies are further accelerating innovation. Overall, SaMD is positioned to deliver sustained value by improving clinical efficiency, supporting personalized care, and strengthening health system performance globally.