Global Artificial Intelligence in Medical Devices Market - 2024-2031

Overview

The global artificial intelligence in medical devices market reached US$ 21.50 billion in 2023 and is expected to reach US$ 228.98 billion by 2031, growing at a CAGR of 34.7% during the forecast period 2024-2031.

Artificial intelligence in medical devices transforming the industry by fostering innovation and enhancing efficiency. Its applications range from data management and diagnostic support to improving patient experiences and ensuring regulatory compliance. AI is poised to be a key player in the future of healthcare. As the industry progresses, the transformative capabilities of AI will undoubtedly influence the development of the next generation of medical devices, making healthcare more efficient, accessible, and effective.

AI technologies, particularly machine learning algorithms, are increasingly being integrated into diagnostic tools to boost accuracy. For instance, AI can analyze medical images such as X-rays, MRIs, and CT scans more swiftly and accurately than traditional methods. This capability helps to lower the rates of misdiagnosis, which is a major concern in healthcare. These factors have driven the global artificial intelligence in medical devices market expansion.

Executive Summary

Market Dynamics: Drivers & Restraints

Integration of AI in Medical Devices

The integration of artificial intelligence in medical devices is significantly driving the growth of global artificial intelligence in the medical devices market and is expected to drive throughout the market forecast period.

Artificial intelligence (AI) is significantly transforming the medical devices industry by introducing innovative solutions and improving operational efficiency across various healthcare applications.

The integration of artificial intelligence (AI) in medical devices involves incorporating advanced technologies such as machine learning, deep learning, natural language processing, and computer vision into medical tools and equipment. This integration enables these devices to analyze complex medical data, assist healthcare professionals in making informed decisions, and automate various processes within clinical environments. All these factors drive global artificial intelligence in medical devices market.

Furthermore, key players in the industry strategies such as partnerships & collaborations, innovative launches, and product approvals would drive this global artificial intelligence in medical devices market. For instance, in March 2023, NVIDIA announced a collaboration with Medtronic, the world's largest healthcare technology provider, to accelerate the integration of artificial intelligence (AI) into the healthcare system and enhance patient care through new AI-based solutions. This partnership aims to incorporate NVIDIA's advanced healthcare and edge AI technologies into Medtronic's GI Genius intelligent endoscopy module, which is developed and manufactured by Cosmo Pharmaceuticals.

Similarly, in November 2024, GE HealthCare launched a new AI Innovation Lab aimed at accelerating the development of early-stage artificial intelligence (AI) solutions. This initiative is part of the company's broader strategy to integrate AI into medical devices, create applications that enhance decision-making throughout the healthcare journey, and leverage AI to improve outcomes and operational efficiencies across the healthcare system. All these factors demand global artificial intelligence in medical devices market.

Moreover, the rising adoption of telehealth services contributes to the global artificial intelligence in medical devices market expansion.

Stringent Regulatory Approvals

The stringent regulatory approvals will hinder the growth of global artificial intelligence in medical devices. The regulatory environment for medical devices that incorporate artificial intelligence (AI) presents considerable complexities that can hinder the timely introduction of new products to artificial intelligence in medical devices market.

The regulation of AI-enabled medical devices is intricate and varies significantly across different regions. For instance, regulatory bodies like the FDA in the United States and the MHRA in the UK have distinct frameworks governing the safety, efficacy, and compliance of these devices. This complexity can lead to delays in product development and artificial intelligence in medical devices market entry.

According to a ScienceDirect research publication in 2024, numerous generative and non-generative AI tools have been developed for various applications in healthcare, with many medical device manufacturers leveraging AI and machine learning (ML) to innovate their products. Regulating AI tools not only facilitates the safe and effective integration of these technologies into healthcare but also fosters public trust.

Regulators must possess a solid understanding of AI and the challenges associated with its development, deployment, and monitoring in healthcare. Thus, the above factors could be limiting the global artificial intelligence in medical devices market's potential growth.

Segment Analysis

The global artificial intelligence in medical devices market is segmented based on product type, technology, application, end-user, and region.

Product Type:

The software segment is expected to dominate the global artificial intelligence in medical devices market share

The software segment holds a major portion of the global artificial intelligence in medical devices market share and is expected to continue to hold a significant portion of the global artificial intelligence in medical devices market share during the forecast period.

The software segment is expected to capture the largest share of the AI in medical devices market, outpacing both hardware and services. This growth is fueled by a rising demand for advanced AI solutions that improve diagnostic accuracy and enhance operational efficiency. For instance, advancements in natural language processing (NLP) have resulted in the creation of software tools that convert physician notes into electronic health records (EHRs), thereby streamlining workflow efficiency.

Furthermore, key players in the industry product launches and approvals would drive this segment's growth in the global artificial intelligence in medical devices market. For instance, in July 2024, Hyperfine announced the clearance of its ninth generation of AI-powered software. This advanced software significantly reduces scan times across various MRI sequences without compromising image quality. The recent FDA clearance further establishes Hyperfine's leadership in AI-driven health technology.

Also, in May 2023, Formus Labs announced that it had received 510(k) clearance from the United States Food and Drug Administration (FDA) for its product, Formus Hip, which is recognized as the first "automated radiological image processing software" specifically designed for pre-operative planning in hip replacement surgeries. This clearance marks a significant milestone for the New Zealand-based company as it prepares to expand its presence in the U.S. market. These factors have solidified the segment's position in the global artificial intelligence in medical devices market.

Geographical Analysis

North America is expected to hold a significant position in the global artificial intelligence in medical devices market share

North America holds a substantial position in the global artificial intelligence in medical devices market and is expected to hold most of the market share.

The growing adoption of healthcare IT solutions is driving the expansion of AI in medical devices. Healthcare providers are increasingly utilizing AI technologies to boost operational efficiency, enhance patient outcomes, and streamline administrative tasks. The rapid increase in healthcare data generated from various sources such as electronic health records (EHRs), medical imaging, and wearable devices creates a need for advanced analytical tools.

AI can effectively process and analyze this vast amount of data, leading to improved diagnostics and personalized treatment plans. The increasing popularity of wearable health monitoring devices is driving demand for AI-enabled solutions that can analyze real-time data and provide actionable insights for both patients and healthcare providers.

Furthermore, in this region, a major number of key players' presence, well-advanced healthcare infrastructure, government initiatives & regulatory support, investments, and product launches & approvals would propel the artificial intelligence in medical devices market growth. For instance, in June 2022, Hyperfine, Inc. made a significant impact in the field of medical imaging with its Swoop system, which is recognized as the first FDA-cleared portable magnetic resonance imaging (MRI) device designed for point-of-care applications. The Swoop system is designed to be portable, allowing it to be brought directly to a patient's bedside.

Also, in March 2024, Clarius Mobile Health received Health Canada approval for its innovative Clarius Bladder AI, a non-invasive tool designed to automatically measure bladder volume in just seconds. This technology is now available in Canada alongside the Clarius PAL HD3, Clarius PA HD3, and Clarius C3 HD3 wireless handheld ultrasound scanners.

Thus, the above factors are consolidating the region's position as a dominant force in the global artificial intelligence in medical devices market.

Asia Pacific is growing at the fastest pace in the global artificial intelligence in medical devices market

Asia Pacific holds the fastest pace in the global artificial intelligence in medical devices market and is expected to hold most of the market share.

The rising rates of chronic illnesses such as diabetes, cardiovascular diseases, and respiratory disorders are driving the demand for advanced medical devices that utilize AI technologies for improved diagnosis and management.

The Asia-Pacific region is increasing the need for healthcare services and technologies that address age-related health issues, thereby boosting the market for artificial intelligence in medical devices investments in healthcare infrastructure across Asia-Pacific countries are facilitating the adoption of AI technologies. Enhanced infrastructure supports the integration of AI into medical devices, improving their functionality and effectiveness.

Furthermore, key players in the region's initiatives such as product launches would drive this artificial intelligence in medical devices market growth. For instance, in April 2024, Singapore's National University Hospital (NUH) launched an AI-driven digestive center that integrates three advanced artificial intelligence systems to enhance the early detection and diagnosis of stomach cancers. This initiative aims to improve clinical outcomes by leveraging AI technologies in the diagnostic process.

Also, in November 2023, Meihua International Medical Technologies Co. (MHUA) announced the launch of Speed Fox, an innovative artificial intelligence (AI)-powered warehouse management and medical device logistics platform. This initiative represents a significant advancement in the field of medical device logistics, aiming to streamline operations and enhance efficiency. Thus, the above factors are consolidating the region's position as the fastest-growing force in the global artificial intelligence in medical devices market.

Competitive Landscape

The major global players in the artificial intelligence in medical devices market include GE HealthCare., Medtronic, Siemens Healthineers AG, NVIDIA Corporation, Koninklijke Philips N.V., Canon Medical Systems, USA, Inc., Aidoc, IBM, Apple Inc., Google DeepMind, HYPERFINE, INC., and Clarius among others.

Emerging Players

The emerging players in the global artificial intelligence in medical devices market include Mediwhale Inc., xCures, Inc., and Formus Labs Ltd among others.

Key Developments

• In May 2024, The Medicines and Healthcare Products Regulatory Agency (MHRA) launched AI Airlock, a new regulatory sandbox designed to address the challenges associated with regulating medical devices that utilize artificial intelligence (AI). This initiative aims to facilitate the safe development and deployment of AI as a Medical Device (AIaMD). AI Airlock serves as a controlled environment where developers can test their AI medical devices under regulatory supervision.
• In March 2024, Clarius Mobile Health, received approval from Health Canada for its innovative Clarius PAL HD3 wireless handheld whole-body ultrasound scanner. This device is notable for its ability to provide high-definition imaging of both superficial and deep anatomical structures using a single dual-array scanner. The Clarius PAL HD3 operates seamlessly with an app on both iPhone and Android smart devices, making it highly accessible for healthcare professionals.

Why Purchase the Report?

• To visualize the global artificial intelligence in medical devices market segmentation based on product type, technology, application, end-user, and region and understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of the artificial intelligence in medical devices market with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping is available in excel consisting of key products of all the major players.

The global artificial intelligence in medical devices market report would provide approximately 76 tables, 70 figures, and 183 pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies