Software as a Medical Device

Global Software as a Medical Device Market to Reach US$53.7 Million by 2030

The global market for Software as a Medical Device estimated at US$22.2 Million in the year 2024, is expected to reach US$53.7 Million by 2030, growing at a CAGR of 15.9% over the analysis period 2024-2030. Cloud, one of the segments analyzed in the report, is expected to record a 14.1% CAGR and reach US$32.0 Million by the end of the analysis period. Growth in the On-Premise segment is estimated at 18.8% CAGR over the analysis period.

The U.S. Market is Estimated at US$6.0 Million While China is Forecast to Grow at 20.7% CAGR

The Software as a Medical Device market in the U.S. is estimated at US$6.0 Million in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$11.6 Million by the year 2030 trailing a CAGR of 20.7% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 11.9% and 14.1% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 12.6% CAGR.

Global Software as a Medical Device Market – Key Trends & Drivers Summarized

Can Code Alone Cure? Why Software as a Medical Device Is Rewriting Healthcare Norms

Software as a Medical Device (SaMD) is revolutionizing healthcare by allowing software programs—independent of any hardware—to perform functions such as diagnosis, treatment recommendation, or disease monitoring. Unlike traditional software embedded within devices, SaMD operates autonomously on mobile devices, cloud platforms, or desktop applications, enabling remote patient management and data-driven clinical decision-making. From detecting cardiac arrhythmias via smartphone ECG algorithms to optimizing insulin dosing through predictive diabetes software, SaMD is transforming how healthcare is delivered, particularly in chronic disease management, mental health, radiology, and digital therapeutics.

What makes SaMD particularly disruptive is its ability to deliver clinical functionality at scale without the need for physical manufacturing. This agility allows rapid updates, iterative improvements, and real-time data analysis—all essential in managing complex conditions like oncology, neurology, and rare diseases. Additionally, the COVID-19 pandemic accelerated the validation of SaMD tools for remote diagnostics and digital triage, paving the way for regulatory agencies like the FDA and EMA to establish fast-track pathways for their approval. The demand for personalized, non-invasive, and continuous monitoring solutions has never been higher, positioning SaMD as a linchpin in the evolving continuum of care.

Why Are Stakeholders from Pharma to Payers Rallying Behind SaMD?

The convergence of cloud computing, artificial intelligence, and mobile technologies has created a fertile environment for SaMD deployment across both clinical and consumer settings. Pharmaceutical companies are increasingly integrating SaMD into their drug development and post-marketing surveillance strategies, using digital biomarkers and real-world data to enhance therapeutic efficacy and monitor patient adherence. These software solutions are also being bundled with companion diagnostics, connected drug delivery devices, and wearable sensors to form comprehensive digital health ecosystems. For payers and providers, SaMD offers tools for early detection, risk stratification, and intervention that can reduce hospitalization rates and improve cost efficiency.

Regulatory bodies have responded by establishing frameworks that ensure patient safety without stifling innovation. The FDA’s Digital Health Software Precertification Program, the EU Medical Device Regulation (MDR), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) have introduced streamlined pathways tailored for SaMD. These frameworks emphasize post-market surveillance, user-centric design, and real-world performance validation. SaMD’s ability to operate independently of hardware allows it to scale rapidly across geographies, making it especially effective in resource-constrained healthcare settings. As value-based care models expand globally, SaMD is poised to become a core enabler of proactive, personalized healthcare.

How Are AI, Machine Learning, and Real-World Data Powering SaMD Evolution?

Artificial intelligence and machine learning are at the heart of SaMD innovation. These technologies allow software to analyze vast datasets, identify patterns, and make predictive assessments with high precision. In radiology, AI-powered SaMD can detect abnormalities such as tumors or fractures from imaging scans with accuracy comparable to or exceeding human specialists. In cardiology, ML algorithms assess ECG signals for arrhythmias or heart failure indicators. In behavioral health, SaMD solutions are being trained to detect early signs of anxiety or depression through speech patterns, facial expressions, and digital interaction data. These capabilities are not just enhancing diagnostic accuracy but enabling earlier and more personalized interventions.

Real-world data (RWD) and real-world evidence (RWE) are further propelling the value proposition of SaMD. As software platforms integrate data from wearables, electronic health records, and patient-reported outcomes, they become powerful tools for continuous learning and real-time risk assessment. Developers are leveraging cloud infrastructure and federated learning models to ensure data privacy while improving algorithmic performance across diverse populations. This feedback loop is enabling regulatory agencies to approve adaptive algorithms—SaMD products that evolve post-approval based on new evidence. The integration of cybersecurity, HIPAA compliance, and user authentication systems ensures that these solutions remain secure and trustworthy.

What’s Fueling the Exponential Rise of Software as a Medical Device?

The growth in the software as a medical device market is driven by several synergistic forces across the digital health landscape. Chief among them is the escalating demand for remote care and self-management tools, especially in chronic and lifestyle-driven diseases. With patients increasingly relying on mobile apps and connected platforms to monitor their health, SaMD is bridging the gap between clinical settings and home-based care. Moreover, the proliferation of smartphones and cloud infrastructure in emerging markets is democratizing access to SaMD, allowing underserved populations to benefit from AI-driven healthcare solutions.

Pharmaceutical and medtech companies are rapidly incorporating SaMD into their go-to-market strategies, viewing it as a means to extend the therapeutic impact of their products and gather post-market insights. Meanwhile, hospitals and payers are leveraging SaMD for triage automation, patient engagement, and early detection to reduce the burden on emergency departments and improve care coordination. Finally, venture capital and private equity investment in SaMD startups is at an all-time high, signaling strong market confidence. As healthcare systems evolve toward personalized, data-centric, and preventive care models, SaMD is positioned to serve as both a clinical tool and a strategic differentiator in global healthcare delivery.

SCOPE OF STUDY:

The report analyzes the Software as a Medical Device market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Deployment (Cloud, On-Premise); Application (Screening & Diagnosis, Monitoring & Alerting, Chronic Disease Management, Digital Therapeutics, Other Applications); End-Use (Hospitals & Clinics, Home Care Settings, Other End-Uses)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Select Competitors (Total 43 Featured) -

• AliveCor
• Apple Inc.
• Arterys Inc.
• Biofourmis
• Brainlab
• Cerner Corporation
• Digital Diagnostics Inc.
• GE Healthcare
• Google Health
• Health Catalyst
• IBM Watson Health
• iSchemaView Inc.
• Medtronic plc
• MindMaze
• Microsoft Health
• Philips Healthcare
• Qlarity Imaging LLC
• Samsung Health
• Siemens Healthineers
• Viz.ai

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