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AI-Powered Medical Devices Market - Global Forecast 2025-2032

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    Report

  • 193 Pages
  • October 2025
  • Region: Global
  • 360iResearch™
  • ID: 6134054
UP TO OFF until Jan 01st 2026
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AI-powered medical devices are redefining the landscape of healthcare innovation, offering new ways for providers to diagnose, monitor, and treat patients more efficiently and intelligently. As artificial intelligence continues to advance, senior decision-makers in healthcare and medtech are increasingly looking to capitalize on cutting-edge technologies that are transforming both clinical and operational outcomes.

Market Snapshot: AI-Powered Medical Devices Market

The AI-powered medical devices market grew from USD 15.64 billion in 2024 to USD 18.36 billion in 2025. It is expected to continue growing at a CAGR of 18.26%, reaching USD 59.84 billion by 2032. This sustained expansion is driven by rapid technological integration, expanded adoption across clinical environments, and evolving reimbursement frameworks that support the implementation of intelligent healthcare solutions.

Scope & Segmentation of the AI-Powered Medical Devices Market

  • Product Categories: Diagnostic equipment, imaging systems, infusion devices, monitoring equipment, surgical robots.
  • Component Types: Hardware (processors, sensors, storage devices), services (consulting, maintenance, training), and software (application software, operating systems).
  • Deployment Modes: Cloud platforms (hybrid, public, private) and on-premise installations.
  • Technologies: Computer vision, deep learning, machine learning, natural language processing, robotics and automation.
  • Application Areas: Cardiology (ECG analysis, echocardiography, hemodynamic monitoring), neurology (EEG analysis, neuroimaging), oncology (cancer screening, tumor analysis), orthopedics, and radiology.
  • End Users: Ambulatory centers, diagnostic centers, home care, hospitals, research institutes.
  • Sales Channels: Direct sales and distributors.
  • Regions Covered: Americas (North America, Latin America), Europe, Middle East & Africa, Asia-Pacific.

Key Takeaways for Senior Decision-Makers

  • AI has become integral to all stages of the device lifecycle—from design and diagnostics to research and post-market surveillance—streamlining medical workflows and improving operational efficiency.
  • Technological advances such as deep learning, computer vision, and real-time predictive analytics are enabling smarter and more adaptive devices that tailor interventions for individualized patient care.
  • Integration of AI with robotic surgical systems and infusion pumps is elevating procedural precision and reducing complication rates, while connected monitoring equipment allows for continuous patient data collection and adaptive responses.
  • Modular system architectures and open interfaces support interoperability, speeding innovation cycles and simplifying integration with existing health data infrastructures.
  • Robust cybersecurity and compliance with evolving regulations are critical, underpinning trust among care providers and ensuring patient data safety as AI becomes more deeply embedded in clinical practice.
  • Strategic partnerships—particularly between medtech manufacturers and software providers—are driving rapid market entry and the successful scaling of AI-driven solutions.

Tariff Impact and Global Supply Chain Dynamics

New US tariff structures in 2025 have altered global supply chains for AI-enabled medical devices. Elevated import duties on components have prompted manufacturers to diversify sourcing, shift assembly to domestic or allied free trade zones, and prioritize the use of standardized subcomponents from local suppliers. This shift supports more agile R&D investment, encourages nearshoring practices, and accelerates regulatory approvals for domestically assembled products while maintaining safety and performance standards.

Methodology & Data Sources

This report is built on a mixed-methods research strategy, combining direct interviews with industry leaders and regulatory officials, in-depth analysis of academic literature and technical publications, and cross-validation with clinical and procurement records. Comprehensive segmentation and geographic analysis leverage both quantitative and qualitative stakeholder feedback, ensuring actionable market intelligence.

Why This Report Matters for Strategic Decision-Making

  • Empower executives with clear visibility into competitive positioning, new partnership opportunities, and regulatory developments in the AI-powered medical devices market.
  • Facilitate informed investment and vendor selection decisions by offering a robust segmentation framework and regional market analysis tailored to emerging trends and operational realities.

Conclusion

AI-powered medical devices are reshaping the healthcare value chain with smarter, more adaptive solutions. Forward-thinking leaders are leveraging these advances to optimize care pathways and sustain long-term innovation within a dynamic regulatory and technological environment.

Table of Contents

1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Adoption of explainable AI algorithms to improve clinician trust and compliance in diagnostics
5.2. Integration of federated learning frameworks to enable multi-center training on sensitive health data
5.3. Deployment of AI driven remote patient monitoring platforms for chronic disease management
5.4. Development of edge computing based AI medical devices for real time analysis in resource constrained settings
5.5. Regulatory pathways and FDA clearance trends for software as a medical device incorporating machine learning
5.6. Use of synthetic data augmentation and generative adversarial networks for robust medical imaging models
5.7. Convergence of multimodal foundation models with imaging, waveforms, and genomics inside regulated devices
5.8. Clinical-grade digital biomarkers from wearables and sensors progressing from wellness use to validated endpoints
5.9. Data partnerships and trusted research environments unlocking access to longitudinal multi-institution datasets without raw data exchange
5.10. Intraoperative AI guidance and video analytics elevating surgical robotics from assistance to supervised autonomy
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. AI-Powered Medical Devices Market, by Product
8.1. Diagnostic Equipment
8.1.1. Endoscopy Systems
8.1.2. Genetic Sequencing
8.1.3. Pathology Systems
8.2. Imaging Systems
8.2.1. CT Scanners
8.2.2. MRI Systems
8.2.3. Pet Scanners
8.2.4. Ultrasound Systems
8.2.5. X-Ray Systems
8.3. Infusion Devices
8.3.1. Insulin Pumps
8.3.2. PCA Pumps
8.3.3. Syringe Pumps
8.4. Monitoring Equipment
8.4.1. ECG Monitors
8.4.2. Fetal Monitors
8.4.3. Vital Signs Monitors
8.5. Surgical Robots
9. AI-Powered Medical Devices Market, by Component
9.1. Hardware
9.1.1. Processors
9.1.2. Sensors
9.1.3. Storage Devices
9.2. Services
9.2.1. Consulting
9.2.2. Maintenance
9.2.3. Training
9.3. Software
9.3.1. Application Software
9.3.2. Operating Systems
10. AI-Powered Medical Devices Market, by Deployment Mode
10.1. Cloud
10.1.1. Hybrid Cloud
10.1.2. Private Cloud
10.1.3. Public Cloud
10.2. On-Premise
11. AI-Powered Medical Devices Market, by Technology
11.1. Computer Vision
11.2. Deep Learning
11.3. Machine Learning
11.4. NLP
11.5. Robotics and Automation
12. AI-Powered Medical Devices Market, by Application
12.1. Cardiology
12.1.1. ECG Analysis
12.1.2. Echocardiography
12.1.3. Hemodynamic Monitoring
12.2. Neurology
12.2.1. EEG Analysis
12.2.2. Neuroimaging
12.3. Oncology
12.3.1. Cancer Screening
12.3.2. Tumor Analysis
12.4. Orthopedics
12.5. Radiology
13. AI-Powered Medical Devices Market, by End User
13.1. Ambulatory Centers
13.2. Diagnostic Centers
13.3. Home Care
13.4. Hospitals
13.5. Research Institutes
14. AI-Powered Medical Devices Market, by Sales Channel
14.1. Direct Sales
14.2. Distributors
15. AI-Powered Medical Devices Market, by Region
15.1. Americas
15.1.1. North America
15.1.2. Latin America
15.2. Europe, Middle East & Africa
15.2.1. Europe
15.2.2. Middle East
15.2.3. Africa
15.3. Asia-Pacific
16. AI-Powered Medical Devices Market, by Group
16.1. ASEAN
16.2. GCC
16.3. European Union
16.4. BRICS
16.5. G7
16.6. NATO
17. AI-Powered Medical Devices Market, by Country
17.1. United States
17.2. Canada
17.3. Mexico
17.4. Brazil
17.5. United Kingdom
17.6. Germany
17.7. France
17.8. Russia
17.9. Italy
17.10. Spain
17.11. China
17.12. India
17.13. Japan
17.14. Australia
17.15. South Korea
18. Competitive Landscape
18.1. Market Share Analysis, 2024
18.2. FPNV Positioning Matrix, 2024
18.3. Competitive Analysis
18.3.1. GE HealthCare Technologies, Inc.
18.3.2. Siemens Healthineers AG
18.3.3. Koninklijke Philips N.V.
18.3.4. Canon Medical Systems Corporation
18.3.5. Fujifilm Holdings Corporation
18.3.6. Samsung Electronics Co., Ltd.
18.3.7. Medtronic plc
18.3.8. Abbott Laboratories
18.3.9. Johnson & Johnson Service, Inc.
18.3.10. Zimmer Biomet Holdings, Inc
18.3.11. NVIDIA Corporation
18.3.12. Exo Imaging, Inc
18.3.13. Empatica Inc.
18.3.14. CLEW Medical Ltd.
18.3.15. Eko Health, Inc.
18.3.16. Medasense Biometrics Ltd.
18.3.17. Oncora Medical
18.3.18. Novo Nordisk A/S
18.3.19. aetherAI Co., Ltd.
18.3.20. Tandem Diabetes Care, Inc.
18.3.21. Becton, Dickinson and Company
18.3.22. Moon Surgical
18.3.23. Vicarious Surgical Inc.
18.3.24. Oracle Corporation
18.3.25. Clairity, Inc.

Companies Mentioned

The companies profiled in this AI-Powered Medical Devices market report include:
  • GE HealthCare Technologies, Inc.
  • Siemens Healthineers AG
  • Koninklijke Philips N.V.
  • Canon Medical Systems Corporation
  • Fujifilm Holdings Corporation
  • Samsung Electronics Co., Ltd.
  • Medtronic plc
  • Abbott Laboratories
  • Johnson & Johnson Service, Inc.
  • Zimmer Biomet Holdings, Inc
  • NVIDIA Corporation
  • Exo Imaging, Inc
  • Empatica Inc.
  • CLEW Medical Ltd.
  • Eko Health, Inc.
  • Medasense Biometrics Ltd.
  • Oncora Medical
  • Novo Nordisk A/S
  • aetherAI Co., Ltd.
  • Tandem Diabetes Care, Inc.
  • Becton, Dickinson and Company
  • Moon Surgical
  • Vicarious Surgical Inc.
  • Oracle Corporation
  • Clairity, Inc.

Table Information