PUBLISHER: The Business Research Company | PRODUCT CODE: 1877498
PUBLISHER: The Business Research Company | PRODUCT CODE: 1877498
An artificial intelligence-driven medical device vigilance platform is a technology-based system that utilizes AI tools to monitor and assess the safety performance of medical devices. It employs machine learning and data analytics to process large volumes of information, identify potential safety issues, and detect early indicators of device-related risks.
The primary components of artificial intelligence-driven medical device vigilance platforms include software, hardware, and services. Software consists of programs and applications that enable computers and devices to execute specific functions. These platforms can be deployed on-premises or through cloud-based systems and are used for applications such as adverse event detection, regulatory compliance, risk management, data analytics, and others. They serve various end-users, including hospitals, medical device manufacturers, regulatory authorities, contract research organizations, and others.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.
The artificial intelligence (AI)-driven medical device vigilance platform market research report is one of a series of new reports from The Business Research Company that provides artificial intelligence (AI)-driven medical device vigilance platform market statistics, including artificial intelligence (AI)-driven medical device vigilance platform industry global market size, regional shares, competitors with a artificial intelligence (AI)-driven medical device vigilance platform market share, detailed artificial intelligence (AI)-driven medical device vigilance platform market segments, market trends and opportunities, and any further data you may need to thrive in the artificial intelligence (AI)-driven medical device vigilance platform industry. This artificial intelligence (AI)-driven medical device vigilance platform 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 (AI)-driven medical device vigilance platform market size has grown exponentially in recent years. It will grow from $1.64 billion in 2024 to $2.02 billion in 2025 at a compound annual growth rate (CAGR) of 23.1%. The growth during the historic period can be attributed to the increasing prevalence of complex medical devices requiring advanced vigilance, rising demand for faster regulatory reporting and compliance, expanding use of big data and real-world evidence in device monitoring, growing need for interoperable vigilance systems, and the increasing emphasis on patient-centric surveillance models.
The artificial intelligence (AI)-driven medical device vigilance platform market size is expected to see exponential growth in the next few years. It will grow to $4.58 billion in 2029 at a compound annual growth rate (CAGR) of 22.7%. The growth in the forecast period can be attributed to the rising number of partnerships aimed at developing interoperable vigilance platforms, increasing demand for faster and more accurate device performance evaluation, growing focus on minimizing manual errors in adverse event reporting, increasing need for cost-effective and scalable AI-driven vigilance systems, and greater emphasis on improving patient outcomes through AI-based insights. Major trends expected during the forecast period include advancements in real-time data analytics for device safety monitoring, enhanced integration of AI algorithms for predictive risk assessment, innovation in generative AI applications for adverse event detection, adoption of natural language processing for automated report analysis, and the advancement of cloud-based vigilance platforms for remote monitoring.
The rising healthcare expenditure is anticipated to drive the growth of the artificial intelligence-driven medical device vigilance platform market in the coming years. Healthcare expenditure represents the total spending by individuals, organizations, and governments on services and initiatives aimed at maintaining or improving health. This expenditure is increasing due to the growing prevalence of chronic diseases, which demand continuous care, long-term treatment, and advanced management resources. Rising healthcare spending supports AI-driven medical device vigilance platforms by providing hospitals and healthcare providers with the financial capacity to adopt comprehensive safety and monitoring systems, ensuring regulatory compliance and enhanced patient protection. For instance, in April 2025, according to the Office for National Statistics, a government agency based in the United Kingdom, government-funded healthcare accounted for the majority of healthcare expenditure, reaching $344 billion (£258 billion) in 2024, an increase of 2.5% in real terms compared to 2023. Therefore, the increase in healthcare expenditure is contributing to the growth of the artificial intelligence-driven medical device vigilance platform market.
The expansion of clinical research is also expected to support the growth of the artificial intelligence-driven medical device vigilance platform market during the forecast period. Clinical research expansion refers to the growing number of clinical trials, research facilities, and resources dedicated to advancing medical knowledge and improving patient outcomes. This growth is driven by increased public and private investments, which strengthen the ability to conduct more studies, streamline research processes, and expand access to innovative treatments. The expansion of clinical research supports AI-driven medical device vigilance platforms by providing healthcare organizations and research institutions with the infrastructure and funding needed to establish robust monitoring systems, ensure compliance with regulations, and enhance patient safety. For example, in December 2024, the United Kingdom government announced a $134 million (£100 million) investment to create 20 new commercial research delivery centers across England, Scotland, Wales, and Northern Ireland. This initiative aims to improve patient access to clinical trials and accelerate research approvals. Therefore, the expansion of clinical research is driving the growth of the artificial intelligence-driven medical device vigilance platform market.
Leading companies in the artificial intelligence-driven medical device vigilance platform market are focusing on developing advanced solutions such as post-market device surveillance platforms to provide actionable insights that improve patient safety and optimize device performance. Post-market device surveillance platforms are designed to monitor and evaluate the safety and performance of medical devices after they are deployed in healthcare environments. For example, in October 2025, Basil Systems, a US-based company specializing in AI-powered platforms, introduced the MedTech Safety Signaling platform. This platform utilizes artificial intelligence to detect potential safety risks early, shifting post-market surveillance toward a proactive safety management approach. It processes regulatory filings, inspection reports, and adverse event narratives using large language models trained on comprehensive industry datasets to uncover patterns that are difficult to identify manually. The system organizes and interprets this data by linking related events to their original sources with confidence levels, enabling manufacturers to identify safety trends, strengthen preventive measures, anticipate regulatory scrutiny, and guide product development decisions.
Major players in the artificial intelligence (AI)-driven medical device vigilance platform market are Amazon Web Services Inc., Johnson & Johnson Services Inc., International Business Machines Corporation, Oracle Corporation, Abbott Laboratories, Medtronic Plc, Siemens Healthineers AG, Stryker Corporation, Koninklijke Philips N.V., GE HealthCare Technologies Inc., Cognizant Technology Solutions Corporation, Boston Scientific Corporation, DXC TECHNOLOGY COMPANY, Baxter International Inc., Wipro Limited, Zimmer Biomet Holdings Inc., Veeva Systems Inc., Medidata Solutions Inc., Tata Consultancy Services Limited, and AssurX Inc.
North America was the largest region in the artificial intelligence (AI)-driven medical device vigilance platform market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in artificial intelligence (AI)-driven medical device vigilance platform report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the artificial intelligence (AI)-driven medical device vigilance platform market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The artificial intelligence (AI)-driven medical device vigilance platform market consists of revenues earned by entities by providing services such as post-market surveillance management, real-world data integration, data cleaning and normalization, safety signal prioritization, and compliance monitoring. The market value includes the value of related goods sold by the service provider or included within the service offering. The artificial intelligence (AI)-driven medical device vigilance platform market also includes sales of data storage appliances, secure enclosures, portable monitoring units, and redundant power systems. 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 (AI)-Driven Medical Device Vigilance Platform Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on artificial intelligence (ai)-driven medical device vigilance platform 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 (ai)-driven medical device vigilance platform ? 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 (ai)-driven medical device vigilance platform 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, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.