US AI-Enabled Medical Devices Market Size Likely to Grow at a CAGR of 15.8% By 2035

It is estimated that the market size of the US AI-enabled medical devices market will grow in the period between 2026 and 2035 to USD 4.82 billion in 2025, and the same will increase to USD 5.58 billion in 2026, and to approximately USD 18.94 billion in 2035, with an annual CAGR of 15.8% within the years 2026-2035.

US AI Enabled Medical Devices Market Revenue and Trends

The US artificial intelligence medical devices market is the market of FDA-cleared or authorised medical devices that use artificial intelligence and machine learning algorithms, including diagnostic imaging software (radiology AI to identify stroke, lung nodules, breast cancer, fractures), cardiology (ECG/AFib detection, echocardiography analysis), pathology and digital slide AI, clinical decision support system, predictive analytics platforms, surgical robotics with AI navigation, patient monitoring and early warning systems, and other new AI-controlled or semi-autonomous devices to enhance the accuracy of diagnostic outcomes, workflow The medical devices AI-enabled market in the US is experiencing a boom because of the increasing pace of FDA approvals (in particular, 510(k) and De Novo pathways), the expanding integration of AI into radiology, cardiology, and oncology workflow, the growing need to detect diseases earlier and minimize diagnostic errors, the momentum of reimbursement of AI as a medical device (SaMD), and ongoing funding of healthcare AI startups and large medtech incumbents.

What are the Factors That Have a Significant Contribution to the Growth of the US AI enabled medical devices market?

The radiology, cardiology, and pathology workload coupled with the chronic shortage of radiologists and pathologists, has led to an increase in the demand for AI-enabled systems that will triage cases, highlight abnormalities, quantify disease, and prioritize reporting. With hospitals and health systems undergoing pressure to increase turnaround time, decrease burnout, and achieve quality care metrics based on value, there has been an increase in the number of providers implementing FDA-cleared solutions of AI to support clinical decision-making and promote consistency in diagnostic results.

New technologies have brought novel products such as foundation models trained on large and multimodal medical datasets, privacy-preserving training through federated learning, edge-based real-time AI inference, explainable AI outputs with heatmaps and confidence scores, win-you-over PACS/RIS and EHR integration, and continual learning models that learn local institution data. Additional factors related to the development of AI in radiology comprise a solid CMS reimbursement of a variety of radiology AI CPT codes, augmenting apprehension regarding the influence of private payers, growing hospital capital budgets dedicated to AI software subscriptions, solid venture/corporate investment on medtech AI, the simplified pathways to SaMD review by the FDA; and the rising clinical evidence regarding enhanced sensitivity/specificity, shorter time-to-diagnosis, and enhanced patient outcomes.

Segment Insight

By Product Type

By products, AI-enabled radiology image software had as of 2025 by far the largest share of the US AI-enabled medical devices market, as the large volumes of procedures in the chest X-ray, mammography, chest/abdomen CT, brain MRI, and musculoskeletal imaging markets were driven by the continued innovation of multi-disease detection algorithms, triage and prioritization tools, quantitative imaging biomarkers, and integration into PACS workflows, which were cited by large numbers of radiologists and hospital executives as superior tools for accelerating interpretation, reducing missed findings, and improving report quality under increasing caseload pressure.

By Distribution Channel

There is the highest market share between direct sales and subscriptions to hospitals, imaging centers, and large radiology groups, which are the main sources of deployment of cloud-based or on-premise AI SaaS platforms, integration with the existing PACS/RIS systems, radiologist training, and continuous monitoring of model performance. Given that these channels offer professional resources to validate clinical workflow optimization, navigation of reimbursement, and constant updating of algorithms, they have been used as the choice of solutions in adopting AI-enabled medical imaging equipment.

Report Scope

List of the prominent players in the US AI-Enabled Medical Devices Market:

• Google Health

• Microsoft Healthcare

• IBM Watson Health

• GE Healthcare

• Siemens Healthineers

• Philips Healthcare

• Medtronic plc

• Viz.ai

• Tempus Labs

• Paige.AI

• iCAD Inc.

• Butterfly Network

• Others

The US AI-Enabled Medical Devices Market is segmented as follows:

By Product Type

• Radiology & Medical Imaging AI

  • CT/MRI Analysis

  • X-Ray Interpretation

  • Ultrasound Guidance

  • Mammography Screening

• Clinical Decision Support Systems

• Patient Monitoring Devices

• Surgical Robots & Navigation

• Wearable Diagnostic Devices

• Others

By Technology

• Machine Learning

• Deep Learning

  • Convolutional Neural Networks

  • Recurrent Neural Networks

  • Transformer Models

• Natural Language Processing

• Computer Vision

• Reinforcement Learning

• Others

By Application

• Oncology

• Cardiology

• Neurology

• Radiology

• Pathology

• Orthopedics

• Others

By End User

• Hospitals

• Diagnostic Centers

• Ambulatory Surgical Centers

• Research Institutes

• Home Healthcare

• Others