Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market Report 2026

Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market Overview

• Artificial Intelligence Or Machine Learning (AI/ML) Medical Device market size has reached to $8.11 billion in 2025 • Expected to grow to $26.46 billion in 2030 at a compound annual growth rate (CAGR) of 26.8% • Growth Driver: Strategic Investments Driving Growth In The Future Of Artificial Intelligence Or Machine Learning Medical Devices • Market Trend: Navigating The Future Of Ai/Ml Medical Devices Through Tech Breakthroughs • North America was the largest region in 2025.

What Is Covered Under Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market?

An artificial intelligence or machine learning (AI/ML) medical device is a medical device that incorporates artificial intelligence and machine learning technologies to analyse medical data, make predictions, support diagnoses, or assist healthcare professionals in decision-making. Artificial intelligence, or machine learning, has several beneficial applications in the medical device sector, including handling data, remote surgical procedures, diagnostic and operational assistance, and clinical trials. The main products included in artificial intelligence machine learning medical devices are systems or hardware and software-as-a medical device. Hardware represents the actual components of a system or the ways it can store and execute the written instructions included in the application's software. The various clinical areas include radiology, cardiology, haematology, and others, which are used by several end-users such as hospitals and healthcare providers, patients, pharmaceutical and biotechnology companies, healthcare payers, and others.

What Is The Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market Growth Forecast?

The artificial intelligence or machine learning (ai/ml) medical device market size is expected to see exponential growth in the next few years. It will grow to $26.46 billion in 2030 at a compound annual growth rate (CAGR) of 26.8%. The growth in the forecast period can be attributed to rising adoption of precision medicine, expansion of telehealth services, regulatory approvals for AI medical devices, demand for early disease detection, growth of value-based healthcare models. Major trends in the forecast period include ai-powered diagnostic imaging, clinical decision support systems, remote patient monitoring devices, predictive healthcare analytics, robotic-assisted medical procedures.

Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market Segmentation

1) By Product: System Or Hardware, Software-As-A Medical Devices 2) By Clinical Area: Radiology, Cardiology, Hematology, Other Clinical Areas 3) By End-User: Hospitals And Healthcare Providers, Patients, Pharmaceuticals And Biotechnology Companies, Healthcare payers, Other End-Users Subsegments: 1) By System Or Hardware: Diagnostic Imaging Systems, Surgical Robots, Monitoring Devices 2) By Software-As-A-Medical Device: AI Diagnostic Software, Clinical Decision Support Systems, Predictive Analytics Platforms

What Is The Driver Of The Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market?

Investments in healthcare AI are expected to propel the growth of the artificial intelligence or machine learning medical device market going forward. Healthcare AI (Artificial Intelligence) refers to applying AI technologies in the healthcare industry to improve healthcare delivery, diagnosis, treatment, and overall patient care. Investments in AI healthcare are driven by the potential for AI and ML technologies to revolutionise healthcare delivery, improve patient outcomes, and enhance operational efficiency. For instance, in March 2023, according to the Department of Health and Social Care, a UK-based government department, over 300,000 patients benefited from $147.2 million (£123 million) invested in 86 AI technologies over three rounds of awards. Additionally, Mendelian, a UK-based digital health startup, has been awarded $1.7 million (£1.4 million) to support an AI system that identifies patients with undiagnosed rare diseases. Further, Medtronic, a US-based medical device company, was awarded $3.18 million (£2.5 million) to further develop an AI-based medical device called GI Genius. Therefore, investments in healthcare AI drive the growth of the artificial intelligence and machine learning medical device market.

Key Players In The Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market

Major companies operating in the artificial intelligence or machine learning (ai/ml) medical device market are General Electric; Medtronic PLC; Canon Inc.; Nvidia Corporation; Siemens Healthineers AG; Koninklijke Philips N.V.; Stryker Corporation; RadNet Inc.; ShanghAI United Imaging Healthcare Co. Ltd.; Tempus; DataRobot Inc.; DeepMind Technologies Limited; Paige AI Inc.; Aidoc Medical Ltd.; Butterfly Network Inc.; Aidoc Medical; CellaVision AB; Clarius Mobile Health Corp.; Subtle Medical Inc.; Owkin Inc.; Cleerly Inc.; Behold.ai; Viz.AI Inc.; Arterys Inc.; Caption Health; Enlitic Inc.; Hyperfine Inc.; Nanox AI Ltd.

Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market Trends and Insights

Major companies operating in the artificial intelligence (AI) and machine learning (ML) medical device market are focusing on developing advanced technologies such as artificial intelligence (AI)-driven performance insights to enhance surgical precision, optimise clinical workflows, and improve patient outcomes through data-driven decision support. Artificial intelligence (AI)-driven Performance Insights is an advanced analytics system that uses artificial intelligence algorithms to analyse surgical videos and generate actionable insights to improve surgical performance, efficiency, and training. For instance, in April 2024, Medtronic plc, an Ireland-based medical devices company, launched 14 new AI-driven Performance Insights algorithms and Touch Surgery Live Stream technology, designed to enhance laparoscopic and robotic-assisted surgical procedures. These solutions enable AI-based post-operative analysis, delivering detailed insights into surgical techniques, and offer real-time, remote observation for improved surgical education and connectivity, thereby setting a new benchmark in AI-powered surgical performance.

What Are Latest Mergers And Acquisitions In The Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market?

In April 2024, GE HealthCare, a US-based medical technology and digital solutions company, acquired MIM Software for an undisclosed amount. Through this acquisition, GE HealthCare aims to strengthen its AI-powered imaging and workflow capabilities in oncology, urology, neurology, and cardiology by integrating MIM Software’s advanced image-analysis and multi-modality processing technologies. MIM Software is a US-based medical imaging software provider that develops AI and machine learning (ML)-enabled solutions for image analysis, processing, and treatment planning

Regional Insights

North America was the largest region in the artificial intelligence machine learning (AI/ML) medical device market in 2025. The regions covered in this market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in this market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain

What Defines the Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market?

The artificial intelligence or machine learning (AI/ML) medical device market consists of revenues earned by entities by providing treatment planning and personalisation, predictive analytics, monitoring, and alert systems. The market value includes the value of related goods sold by the service provider or included within the service offering. The artificial intelligence or machine learning (AI/ML) medical device market also includes sales of smart wearable health monitors, medical imaging devices, and diagnostic devices. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

How is Market Value Defined and Measured?

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified). The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

What Key Data and Analysis Are Included in the Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market Report 2026?

The artificial intelligence or machine learning (ai/ml) medical device market research report is one of a series of new reports from The Business Research Company that provides market statistics, including industry global market size, regional shares, competitors with the market share, detailed market segments, market trends and opportunities, and any further data you may need to thrive in the artificial intelligence or machine learning (ai/ml) medical device industry. The market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future state of the industry.