PUBLISHER: The Business Research Company | PRODUCT CODE: 1970133
PUBLISHER: The Business Research Company | PRODUCT CODE: 1970133
An AI/ML medical device, short for artificial intelligence or machine learning medical device, refers to a medical device that integrates artificial intelligence and machine learning technologies for the analysis of medical data, prediction generation, assistance in diagnoses, or aiding healthcare professionals in decision-making processes. The medical device sector has witnessed various advantageous applications of artificial intelligence and machine learning, including data management, facilitation of remote surgical procedures, diagnostic and operational support, and contributions to clinical trials.
The primary components encompassed in AI/ML medical devices are hardware systems and software-as-a-medical device. Hardware constitutes the tangible elements of a system or the mechanisms used for storing and executing the written instructions embedded in the application's software. These devices find application across different clinical domains such as radiology, cardiology, hematology, among others, catering to diverse end-users, including hospitals and healthcare providers, patients, pharmaceutical and biotechnology companies, healthcare payers, and more.
Tariffs have moderately affected the AI or machine learning medical device market by increasing costs of imported sensors, imaging components, and advanced processing units. Diagnostic imaging and robotic-assisted devices are most impacted, particularly in asia-pacific manufacturing hubs. Higher device costs can limit adoption in cost-sensitive healthcare systems. However, tariffs are encouraging localized manufacturing and software-centric innovation. This shift is supporting supply chain resilience and long-term market sustainability.
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 artificial intelligence or machine learning (ai/ml) medical device market statistics, including artificial intelligence or machine learning (ai/ml) medical device industry global market size, regional shares, competitors with a artificial intelligence or machine learning (ai/ml) medical device market share, detailed artificial intelligence or machine learning (ai/ml) medical device 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. This artificial intelligence or machine learning (ai/ml) medical device market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The artificial intelligence or machine learning (ai/ml) medical device market size has grown exponentially in recent years. It will grow from $8.11 billion in 2025 to $10.24 billion in 2026 at a compound annual growth rate (CAGR) of 26.2%. The growth in the historic period can be attributed to growth of medical imaging adoption, shortage of healthcare professionals, increase in chronic disease prevalence, digitalization of healthcare data, advancements in medical device technology.
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.
Growing investments in healthcare AI are anticipated to drive the expansion of the artificial intelligence and machine learning medical device market in the coming years. Healthcare AI refers to the use of artificial intelligence technologies within the healthcare sector to enhance diagnosis, treatment, service delivery, and overall patient care. Increased funding in healthcare AI is largely fueled by the ability of AI and ML to transform healthcare operations, improve clinical outcomes, and boost efficiency. For example, in March 2023, data from the Department of Health and Social Care, a UK-based government body, indicated that more than 300,000 patients benefited from $147.2 million (£123 million) invested across 86 AI technologies through three funding rounds. In addition, Mendelian, a UK-based digital health startup, received $1.7 million (£1.4 million) to support the development of an AI system aimed at identifying patients with undiagnosed rare conditions. Furthermore, Medtronic, a US-based medical device manufacturer, was granted $3.18 million (£2.5 million) to advance the development of its AI-powered medical device, GI Genius. As a result, rising investments in healthcare AI continue to accelerate the growth of the artificial intelligence and machine learning medical device market.
Leading companies operating in the artificial intelligence and machine learning medical device market are concentrating on the development of advanced technologies such as AI-driven performance insights to improve surgical accuracy, streamline clinical workflows, and enhance patient outcomes through data-supported decision-making. AI-driven Performance Insights refers to an advanced analytical system that utilizes artificial intelligence algorithms to evaluate surgical videos and produce practical insights aimed at improving surgical efficiency, performance, and training. For instance, in April 2024, Medtronic plc, an Ireland-based medical device company, introduced 14 new AI-driven Performance Insights algorithms along with Touch Surgery Live Stream technology to support laparoscopic and robotic-assisted surgeries. These innovations enable AI-powered post-operative analysis with in-depth evaluation of surgical techniques and provide real-time remote viewing to strengthen surgical education and collaboration, establishing a new standard in AI-enabled surgical performance.
In April 2024, GE HealthCare, a US-based medical technology and digital solutions provider, acquired MIM Software for an undisclosed sum. With this acquisition, GE HealthCare seeks to enhance its AI-driven imaging and workflow solutions across oncology, urology, neurology, and cardiology by incorporating MIM Software's advanced image analysis and multi-modality processing technologies. MIM Software is a US-based medical imaging software company that develops artificial intelligence and machine learning-enabled solutions for image analysis, processing, and treatment planning.
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.
North America was the largest region in the artificial intelligence machine learning (AI/ML) medical device market in 2025. The regions covered in the artificial intelligence or machine learning (ai/ml) medical device market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
The countries covered in the artificial intelligence or machine learning (ai/ml) medical device market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain
The artificial intelligence or machine learning (AI/ML) medical device market consists of revenues earned by entities by providing treatment planning and personalization, 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 diagnostics 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.
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.
Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market Global Report 2026 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses artificial intelligence or machine learning (ai/ml) medical device market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for artificial intelligence or machine learning (ai/ml) medical device ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The artificial intelligence or machine learning (ai/ml) medical device market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
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