Software as a Medical Device (SaMD) Market to Reach US$ 28.5 Billion by 2031 at a CAGR of 69.31%; North America Leads with 44% Share - Key Players: Siemens Healthineers, Philips, Arterys

The global Software as a Medical Device (SaMD) market is experiencing rapid expansion and is estimated to grow at a CAGR of 69.31 percent during the forecast period 2024-2031. The market was valued at approximately US$ 1.02 billion in 2023 and is projected to reach around US$ 28.5 billion by 2031, driven by accelerating digital transformation in healthcare, increasing adoption of AI-driven clinical decision tools, and rising demand for remote monitoring and virtual care solutions.

Software as a Medical Device, as defined by the International Medical Device Regulators Forum (IMDRF), refers to software intended for one or more medical purposes that performs these functions independently of a physical medical device. SaMD solutions support various clinical applications, including diagnostics, disease management, imaging analysis, and therapeutic guidance. Their ability to deliver real-time insights, enhance clinical accuracy, and operate across connected ecosystems positions SaMD as a transformative force within modern healthcare. As regulatory frameworks evolve and digital health adoption intensifies, the SaMD market is expected to witness significant scaling across key regions worldwide.

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The Software as a Medical Device (SaMD) market refers to the industry focused on standalone software solutions that perform medical functions, such as diagnosis, monitoring, or treatment, without being part of a physical medical device.

Key Developments
✅ October 2025: Major U.S. digital health companies expanded AI-driven SaMD platforms for diagnostics and remote disease monitoring, receiving multiple FDA clearances for autonomous decision-support algorithms.

✅ September 2025: European regulatory bodies accelerated approvals under the MDR framework for cloud-based SaMD solutions in cardiology, neurology, and radiology, boosting digital therapeutic adoption.

✅ August 2025: Asia-Pacific healthcare providers integrated SaMD-based clinical decision tools into hospital IT systems to improve workflow efficiency, patient triage, and chronic disease management.

✅ July 2025: Global medical device manufacturers launched next-generation cybersecurity-enhanced SaMD solutions to meet updated safety and interoperability standards for connected health systems.

✅ May 2025: Digital therapeutics and AI-health startups introduced personalized SaMD platforms combining remote monitoring, predictive analytics, and patient engagement modules.

✅ March 2025: Middle Eastern hospitals expanded deployment of SaMD-assisted imaging and screening tools to improve early diagnosis for oncology, dermatology, and cardiovascular diseases.

Mergers & Acquisitions
✅ November 2025: A leading U.S. health-tech company acquired a regulatory-approved AI-diagnostics SaMD developer to strengthen its clinical decision-support offerings.

✅ August 2025: A European digital health software provider formed a strategic partnership with a global cloud infrastructure company to co-develop secure, scalable SaMD platforms.

✅ June 2025: An Asia-Pacific medtech firm acquired a machine learning-based SaMD analytics startup to expand its portfolio of AI-enabled monitoring and diagnostic applications.

Key Players
Arterys Inc. | Paragon Biosciences (Qlarity Imaging LLC) | Viz.ai, Inc. | VitalConnect | Apple Inc. | iSchemaView Inc. (RAPID) | IDx Technologies Inc. | MaxQ AI Ltd. | Greenfinch Technology | Siemens Healthineers AG | Koninklijke Philips N.V.

Key Highlights
Arterys Inc. - Holds a 9.8% share, driven by its cloud-native AI imaging platform, strong FDA-cleared solutions, and expanding adoption across radiology departments.

Paragon Biosciences (Qlarity Imaging LLC) - Holds a 7.1% share, supported by its AI-based breast cancer diagnostic tools, enhanced clinical decision support, and growing oncology footprint.

Viz.ai, Inc. - Holds a 12.4% share, fueled by its AI-powered stroke detection and care coordination platform widely deployed in hospitals worldwide.

VitalConnect - Holds a 5.6% share, driven by its AI-enabled wearable biosensors, remote patient monitoring solutions, and strong engagement in digital health.

Apple Inc. - Holds an 11.3% share, supported by its health-focused ecosystem, advanced biometric monitoring features, and strategic investments in medical-grade diagnostics.

iSchemaView Inc. (RAPID) - Holds a 10.2% share, recognized for its RAPID imaging platform for stroke triage, strong clinical validation, and global hospital partnerships.

IDx Technologies Inc. - Holds a 6.4% share, driven by its FDA-approved autonomous AI diagnostic systems and increasing demand in ophthalmology.

MaxQ AI Ltd. - Holds a 4.9% share, supported by its AI-driven acute care imaging solutions enhancing diagnostic accuracy for critical conditions.

Greenfinch Technology - Holds a 3.8% share, fueled by its AI-based healthcare software development capabilities and integration in clinical imaging workflows.

Siemens Healthineers AG - Holds a 15.7% share, driven by its extensive imaging portfolio, advanced AI platforms, and large global customer base.

Koninklijke Philips N.V. - Holds a 12.8% share, supported by its enterprise imaging solutions, AI-enabled diagnostics, and innovations in patient monitoring.

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Market Drivers

- Increasing adoption of digital health technologies and AI-driven clinical decision tools across healthcare systems.

- Rising demand for remote patient monitoring, chronic disease management, and virtual care solutions.

- Growing regulatory support from FDA, EMA, and other authorities enabling faster approvals for digital therapeutics and diagnostic software.

- Expansion of cloud computing, mobile health apps, and wearable technologies integrating SaMD functionalities.

- Increasing focus on personalized medicine and data-driven treatment pathways requiring advanced software tools.

- Rising healthcare costs driving adoption of scalable, software-based solutions to improve efficiency and outcomes.

- Growing prevalence of chronic diseases and aging populations increasing demand for continuous monitoring solutions.

Industry Developments

- Launch of AI- and machine learning-powered SaMD applications for diagnostics, imaging interpretation, and therapeutic interventions.

- Strategic collaborations between medtech companies, software developers, and healthcare providers to expand SaMD ecosystems.

- Development of cybersecurity-enhanced platforms to ensure safe data exchange and reduce compliance risks.

- Increasing investment in digital therapeutics (DTx) platforms receiving regulatory and reimbursement approvals worldwide.

- Expansion of SaaS-based SaMD models offering scalability, remote updates, and improved patient engagement.

- Rising integration of SaMD with wearables, smartphones, and IoT-enabled health devices for real-time insights.

Regional Insights

North America - 44% share: "Driven by strong regulatory frameworks, rapid digital health adoption, and significant investment in AI-based SaMD solutions."

Europe - 30% share: "Supported by stringent medical device regulations, rising digital therapeutics adoption, and expanding health IT infrastructure."

Asia Pacific - 20% share: "Fueled by growing digital health initiatives, rising smartphone penetration, and increasing investment in AI-driven healthcare tools."

Latin America - 4% share: "Boosted by expanding telehealth adoption and growing healthcare digitalization efforts."

Middle East & Africa - 2% share: "Driven by smart healthcare projects, improving IT infrastructure, and rising acceptance of remote monitoring tools."

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Key Segments

➥ By Device Type
Wearable Devices: Includes smartwatches, fitness trackers, biosensors, and health monitoring wearables that enable continuous tracking of vital parameters and remote patient monitoring.

PCs/Laptops: Used for data analysis, clinical documentation, teleconsultations, and integration with healthcare information systems for efficient medical workflows.

Smartphones/Tablets: Mobile-enabled platforms supporting telehealth, remote diagnostics, patient engagement apps, and real-time health data tracking.

➥ By Application
Diagnostic: Digital tools and connected devices used for early disease detection, real-time monitoring, and remote diagnostic evaluations.

Clinical Management: Solutions enabling treatment planning, medication management, patient monitoring, clinical decision support, and workflow optimization.

➥ By Deployment Method
Cloud-Based: Offers scalable storage, remote accessibility, seamless updates, and interoperability across multiple healthcare systems.

On-Premise: Locally hosted infrastructure ensuring strong control over data security, customization, and compliance for healthcare institutions.

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