AI-Enabled Software as a Medical Device (SaMD) - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)

The aI-Enabled software as a medical device market size is expected to grow from USD 9.25 billion in 2025 to USD 11.33 billion in 2026 and is forecast to reach USD 31.18 billion by 2031 at 22.45% CAGR over 2026-2031. This report is Segmented by Software Type (Diagnostic, Therapeutic, Monitoring, CDS, Workflow), Clinical Specialty (Radiology, Cardiology, Neurology, Pand More), End User (Hospitals, Ambulatory Care, Diagnostic Labs, Home Healthcare, Specialty Clinics), Deployment (Cloud, On-Premises, Edge-Enabled/Hybrid), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are in Value (USD).

Global AI-Enabled Software As A Medical Device (SaMD) Market Trends and Insights

Rising FDA and Global Regulatory Clarity for AI-Enabled SaMD

Regulatory clarity has long shaped commercialization in the AI-enabled software as a medical device (SaMD) market, and the 2025 to 2026 period marked a clear improvement. The FDA’s January 2025 draft guidance clarified submission expectations for locked and continuously learning algorithms across all three major marketing pathways. The February 2026 Quality Management System Regulation update aligned FDA requirements more closely with ISO 13485:2016, while the FDA’s PCCP framework, finalized in December 2024, enabled pre-authorized future algorithm changes. In Europe, MDCG 2025-6 clarified how AI Act obligations interact with MDR and IVDR quality systems, helping companies prepare unified compliance files.

Hospital Demand for Diagnostic Workflow Automation

Hospital demand remained a major driver for the AI-enabled software as a medical device (SaMD) market, as providers faced rising imaging and diagnostic workloads without proportional growth in specialist staffing. Workforce shortages were especially relevant in radiology and other data-heavy specialties where case volumes increased faster than expert capacity. Aidoc’s deployment across nearly 2,000 hospitals and its USD 150 million Series E financing in April 2026 showed stronger hospital interest in broad diagnostic augmentation platforms rather than isolated single-condition tools. This demand also supported AI integration into imaging systems and workflow infrastructure.

Clinical Validation Burden Across Diverse Populations

Clinical validation across diverse populations remains a key constraint in the AI-enabled software as a medical device (SaMD) market, as regulators and providers place greater emphasis on subgroup performance and data provenance. The FDA’s January 2025 draft guidance made it clear that future submissions would face closer scrutiny on demographic coverage and algorithm behavior across subpopulations. This increases the burden on developers, as studies must demonstrate reliable performance across patient groups that differ by age, ethnicity, disease burden, and equipment setting. For multi-indication products, this can extend evidence-building timelines by 12 to 18 months and increase the capital required before broad commercialization. Qure.ai’s wide deployment footprint demonstrates the value of a strong validation strategy, while highlighting the difficulty smaller vendors face in replicating this model at scale.

Other drivers and restraints analyzed in the detailed report include:

• Expansion of Evidence-Generating Real-World Data and Registry Programs
• Higher Reimbursement Interest for AI-Assisted Triage and Diagnosis
• Cybersecurity, Data Integrity, and Model Drift Risks

Segment Analysis

Diagnostic SaMD held 38.55% of the AI-enabled software as a medical device (SaMD) market share in 2025, supported by strong adoption in radiology, cardiology, and ophthalmology. Image-rich workflows, defined reference standards, high digital volumes, and clearer approval pathways helped the segment commercialize earlier than many treatment-focused workflows. Therapeutic SaMD was the fastest-growing software type, with this portion of the AI-enabled software as a medical device (SaMD) market size projected to expand at a 25.93% CAGR through 2031.

Digital therapeutics, adaptive neuromodulation, and treatment planning tools drove growth by influencing billable care pathways beyond diagnostic interpretation. Monitoring SaMD also gained scale as providers combined wearable inputs, longitudinal data, and EHR-linked risk models to identify patients earlier and manage them over time. The AI-enabled software as a medical device (SaMD) market shifted from software that mainly read or flagged cases toward solutions that supported treatment and follow-up decisions.

Radiology and imaging commanded 42.22% of revenue in 2025, maintaining the largest specialty position in the AI-enabled software as a medical device (SaMD) market. The specialty benefited from high procedure volumes, established digital infrastructure, and a deep installed base of AI-enabled tools. Large imaging vendors strengthened this position by embedding software into device portfolios rather than offering AI only as a separate add-on.

GE HealthCare’s March 2026 FDA clearance for Photonova Spectra and Philips’ March 2026 FDA clearance for Verida Spectral CT showed how imaging refresh cycles became distribution channels for AI-enabled clinical workflows. Pathology was the fastest-growing specialty, with this segment of the AI-enabled software as a medical device (SaMD) market size projected to rise at a 24.67% CAGR through 2031. Wider whole-slide imaging use, stronger foundation models, and oncology workflows combining image, molecular, and clinical signals supported this momentum.

Complete Report Scope:

• By Software Type
  • Diagnostic SaMD
  • Therapeutic SaMD
  • Monitoring SaMD
  • Clinical Decision Support SaMD
  • Workflow and Administrative SaMD
• By Clinical Specialty
  • Radiology and Imaging
  • Cardiology
  • Neurology
  • Pathology
  • Ophthalmology
  • Oncology
  • Others
• By End User
  • Hospitals
  • Ambulatory Care Centers
  • Diagnostic Laboratories
  • Home Healthcare Settings
  • Specialty Clinics
• By Deployment Mode
  • Cloud-Based
  • On-Premises
  • Edge-Enabled and Hybrid
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 41.56% of the AI-enabled software as a medical device (SaMD) market share in 2025, making it the most advanced commercial region. Strong hospital digitization, an active regulatory pathway, and a more accessible payment system for AI-enabled products supported its leadership. The RAPID Coverage Pathway, announced by CMS and the FDA in April 2026, improved commercialization conditions by narrowing the gap between authorization and Medicare national coverage for eligible Breakthrough Device products.

Europe is the second-largest regional bloc in the AI-enabled software as a medical device (SaMD) market. Its growth trajectory is being shaped by the interaction between the MDR, IVDR, and the AI Act, rather than by a single approval system. MDCG 2025-6 clarified how AI Act obligations mapped onto existing device quality processes, helping manufacturers create unified documentation packages and reduce duplicate compliance work. The May 2026 Digital Omnibus political agreement also gave manufacturers more preparation time for AI-embedded medical device obligations without changing the broader regulatory direction. Germany, the United Kingdom, and France remain the leading markets, while Italy, Spain, and other European countries are expanding as digitization programs and digital health funding increase the hospital base capable of deploying AI software.

Asia-Pacific is the fastest-growing regional segment in the AI-enabled software as a medical device (SaMD) market, with a projected CAGR of 25.56% through 2031. Diagnostic workforce shortages, expanding imaging infrastructure, and large, varied patient datasets are driving growth by supporting deployment and model development. India stood out as Qure.ai deployed across hundreds of public-sector sites, analyzed more than 39 million patient scans, and received a Gates Foundation grant in January 2026 to build AI-powered point-of-care ultrasound for low-resource environments. Japan’s 2026 Class II SaMD certification for Impakt Health’s remote monitoring platform showed broader regulatory acceptance.

List of Companies Covered in this Report:

• Abbott Laboratories
• Aidoc Medical Ltd.
• AliveCor
• Boston Scientific
• Butterfly Network, Inc.
• Caption Health, Inc.
• Captis AI, Inc.
• Clinical Body Area Network, Inc.
• GE HealthCare Technologies Inc.
• HeartFlow, Inc.
• Intuitive Surgical, Inc.
• iRhythm Technologies
• Koninklijke Philips
• Medtronic
• Nanox Imaging
• Paige.AI, Inc.
• Qure.ai Technologies Private Limited
• Siemens Healthineers
• Tempus AI, Inc.
• Viz.ai, Inc.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support