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市场调查报告书
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1747681

全球医疗设备人工智慧/机器学习市场

Artificial Intelligence / Machine Learning in Medical Devices
出版日期: | 出版商: Global Industry Analysts, Inc. | 英文 134 Pages | 商品交期: 最快1-2个工作天内

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简介目录

预计到 2030 年，全球医疗设备人工智慧/机器学习市场规模将达到 140 亿美元

全球人工智慧/机器学习医疗设备市场规模预计在2024年为47亿美元，预计到2030年将达到140亿美元，2024年至2030年的复合年增长率为19.8%。人工智慧/机器学习系统/硬体是本报告分析的细分市场之一，预计其复合年增长率为18.2%，到分析期结束时规模将达到88亿美元。软体即医疗设备细分市场在分析期间的复合年增长率预计为22.8%。

美国市场规模估计为 12 亿美元，中国市场预计复合年增长率为 18.8%

美国医疗设备领域的人工智慧/机器学习市场规模预计在2024年达到12亿美元。预计到2030年，作为世界第二大经济体的中国市场规模将达到22亿美元，在2024-2030年的分析期间内，复合年增长率为18.8%。其他值得关注的区域市场包括日本和加拿大，预计在分析期间内，这两个市场的复合年增长率分别为18.0%和17.3%。在欧洲，预计德国市场的复合年增长率约为14.7%。

全球医疗设备市场中的人工智慧/机器学习—主要趋势和驱动因素摘要

为什么人工智慧和机器学习将改变医疗设备的性能、实用性和设计？

人工智慧 (AI) 和机器学习 (ML) 正在重新定义医疗设备的功能，使其能够跨多个临床学科进行即时数据分析、预测性诊断和自适应治疗性介入。透过将智慧演算法嵌入硬体平台，医疗设备正从被动工具演变为主动决策支援和自动化系统。 AI/ML 整合如今已成为数位健康转型的核心，能够提高临床准确性、提升工作流程效率并提供个人化医疗服务。

机器学习驱动的诊断设备可以快速分析影像、波形和感测器数据，从而检测异常情况、优先处理危重病例并减少诊断的变异性。例如，在放射学领域，人工智慧驱动的影像处理系统可以检测早期肿瘤、对骨折进行分类并分割解剖结构，其精度堪比人类增强；而机器学习驱动的可穿戴设备和植入式设备则可以持续监测心电图、血糖浓度和血氧饱和度等生理参数，以预测病情恶化、标记异常值并实现预防性护理干预。

在治疗应用中，AI 演算法支援设备导航手术、剂量优化和封闭回路型刺激系统。机器人辅助手术平台利用机器学习 (ML) 来优化运动控制并即时绘製解剖细微差别。 AI 驱动的输液帮浦和神经调节设备可根据患者特定的回馈迴路动态调整治疗方法。随着监管机构批准越来越多核准AI/ML 的软体即医疗设备(SaMD) 解决方案，智慧型装置功能正成为临床的必要事项，而非竞争的噱头。

演算法检验、资料生态系统和边缘 AI 如何推动医疗设备中 AI/ML 的应用？

演算法检验和模型透明度是医疗保健领域人工智慧获得信任和采用的基础。开发者正在投资大型多中心训练资料集和真实世界证据 (RWE)，以确保演算法在不同患者属性和临床环境中的通用性。联邦学习和可解释人工智慧 (XAI) 等技术正日益普及，因为它们能够在不损害资料隐私或可解释性的情况下持续改进模型。包括 FDA 在内的监管机构正在建立自适应框架，以批准部署后可核准的机器学习演算法，从而支援更安全、生命週期可管理的创新。

数据整合正在进一步加速人工智慧/机器学习在医疗设备上的部署。如今，医疗设备已与云端平台、医院资讯系统 (HIS)、电子健康记录(EHR) 和穿戴式生态系统连接，将感测器资料情境化，并提升临床相关性。 HL7 FHIR 等互通性标准正在促进跨平台资料交换，使人工智慧演算法能够从多模态资料来源中获取洞察。这些洞察不仅提高了诊断和治疗的准确性，也有助于患者的长期管理。

边缘人工智慧（Edge AI，将机器学习模型直接部署到设备上）是延迟敏感型应用（例如照护现场诊断、可携式超音波和用于远端监控的可穿戴设备）的关键推动因素。透过最大限度地减少对持续云端连线的依赖，边缘人工智慧可确保低频宽和分散式环境中的回应能力、资料隐私和可用性。更小的处理器尺寸、低功耗运算的进步以及嵌入式机器学习晶片组正在支援能够即时自主决策的智慧、自足式医疗设备的发展。

哪些临床领域和地理市场正在推动医疗设备中 AI/ML 的应用？

由于影像强度高、资料复杂且诊断精准度高，放射科、心臟科、神经科和肿瘤科是人工智慧/机器主导医疗设备应用最先进的领域。医院和影像中心正在部署人工智慧超音波、核磁共振、CT 和 PET 系统，以实现工作流程自动化，缩短从扫描到诊断的时间，并减轻放射科负担。在循环系统，人工智慧心电图监测仪、穿戴式心律不整检测器和心臟衰竭预测系统正在改善慢性疾病监测和风险分层。

手术机器人、麻醉监护和重症患者监护系统正在整合机器学习演算法，以优化术中决策、人工呼吸器管理和术后恢復路径。在消费者健康和居家照护领域，智慧血糖仪、数位听诊器和跌倒侦测穿戴装置等人工智慧设备正在弥合持续照护的差距，并实现可扩展的慢性病管理。牙科和眼科设备也正在整合人工智慧，用于影像分析、治疗计画和风险检测，不断拓展应用的边界。

北美在人工智慧/机器学习医疗设备领域占据主导地位，这得益于早期监管核准、强大的数位医疗基础设施以及人工智慧新兴企业和医疗科技巨头的坚实基础。紧随其后的是欧洲，其重点关注符合伦理道德的人工智慧、符合资料隐私保护规范 (GDPR) 以及公私合作创新框架。亚太地区正在快速应用人工智慧/机器学习，尤其是在中国、日本、韩国和印度。这些地区的政府投资、数位转型挑战以及大量尚未开发的患者资料集正在加速人工智慧/机器学习的整合。拉丁美洲、中东和非洲的成长预计将受到行动诊断、远端医疗连接设备以及公共卫生基础设施现代化的推动。

监管标准、经营模式和临床整合策略如何改变竞争格局？

全球法规结构正在不断发展，以适应支援人工智慧/机器学习 (AI/ML) 的设备的独特生命週期。监管机构正在发布有关演算法透明度、真实世界检验和变更管理的指南，以适应持续学习模型。美国食品药物管理局 (FDA) 的人工智慧/机器学习医疗软体行动计画和欧盟医疗器材法规 (MDR) 分类标准正在帮助定义安全且可重复部署的路径。这些框架鼓励早期人工智慧开发者将监管策略纳入其产品设计的核心。

经营模式正转向人工智慧即服务、基于订阅的分析和基于结果的合约。设备製造商正在将人工智慧模组作为差异化附加元件，为医院提供预测洞察、工作流程效率和诊断平台。与云端服务供应商、电子病历 (EHR) 供应商和临床人工智慧新兴企业建立策略合作伙伴关係，使医疗科技公司能够扩展其人工智慧/机器学习集成，而无需在内部重建全端功能。主导的诊断和分诊工具的报销策略正在兴起，进一步支持其商业可行性。

成功的应用取决于无缝的临床整合。开发人员专注于直觉的使用者介面、临床医生的环路控制以及与现有工作流程的集成，以避免警报疲劳和工作流程中断。培训计划、真实案例研究和上市后监测系统对于建立临床医生的信任和确保安全应用至关重要。随着竞争加剧，人工智慧设备的差异化将越来越不仅取决于演算法的复杂程度，还取决于临床相关性、互通性和监管敏捷性。

哪些因素将推动医疗设备市场 AI/ML 的成长？

受医疗保健数位化程度不断提高、患者数据不断增长以及临床对准确性、自动化和决策支援需求的推动，医疗设备的人工智慧/机器学习市场正在快速成长。运算能力、数据可用性和演算法成熟度的整合，使医疗设备成为智慧化的情境感知工具，在诊断、监测和治疗方面主动协助临床医生。

边缘人工智慧、可解释演算法和监管框架的进步，正在使人工智慧设备更加安全、扩充性且具有商业性可行性。随着临床工作流程要求在护理点获得切实可行的洞察，以及支付方推动基于价值的治疗结果，智慧医疗设备正与医疗保健系统转型的更广泛目标相契合。

未来将取决于人工智慧设备如何有效融入临床决策，如何平衡创新与安全，以及如何在患者治疗效果方面取得显着改善。随着医疗设备从被动仪器发展成为认知协作者，人工智慧/机器学习能否定义自适应、个人化、数据主导医疗服务的下一个前沿？

部分

产品类型（系统/硬体、医疗设备软体）；临床领域（放射学、心臟病学、血液学、其他临床领域）

调查企业范例（共34家企业）

  • AEYE Health
  • AliveCor
  • Atomwise
  • Behold.ai
  • BenevolentAI
  • BioSerenity
  • Butterfly Network
  • Clarius Mobile Health
  • CorticoMetrics
  • Cyclica
  • Eko Health
  • Empatica
  • Enlitic
  • Exscientia
  • GE Healthcare
  • HeartFlow
  • iCAD Inc.
  • Lantheus Holdings
  • Medtronic
  • NVIDIA

关税影响係数

全球产业分析师根据公司总部所在国家、製造地、进出口（成品和原始OEM）来预测其竞争地位的变化。这种复杂且多面向的市场动态预计将以多种方式影响竞争对手，包括人为提高销货成本、盈利下降、供应链重组以及其他微观和宏观市场动态。

全球产业分析师密切关注来自全球顶尖首席经济学家（14,949位）、智库（62家）以及贸易和产业协会（171家）的专家的意见，以评估其对生态系统的影响并应对新的市场现实。我们追踪了来自每个主要国家的专家和经济学家对关税及其对本国影响的看法。

全球产业分析师预计，这场动盪将在未来2-3个月内逐渐平息，新的世界秩序将更加清晰地建立。全球产业分析师正在即时追踪这些事态发展。

2025年4月：谈判阶段

在4月的报告中，我们将探讨关税对全球整体市场的影响，并提供区域市场调整。我们的预测是基于历史数据和不断变化的市场影响因素。

2025年7月：最终关税调整

在各国宣布最终重置后，客户将在 7 月收到免费更新，最终更新将包含明确的关税影响分析。

相互和双边贸易及关税影响分析：

美国<>中国<>墨西哥<>加拿大<>欧盟<>日本<>印度<>其他176个国家

领先的产业经济学家：全球产业分析师知识库追踪了 14,949 位经济学家，其中包括来自民族国家、智库、贸易和产业协会、大型企业以及各领域专家的最具影响力的首席经济学家，他们共用了这场前所未有的全球经济状况模式转移的影响。我们超过 16,491 份报告大多遵循基于里程碑的两阶段发布计划。

目录

第一章调查方法

第二章执行摘要

  • 市场概览
  • 主要企业
  • 市场趋势和驱动因素
  • 全球市场展望

第三章市场分析

  • 美国
  • 加拿大
  • 日本
  • 中国
  • 欧洲
  • 法国
  • 德国
  • 义大利
  • 英国
  • 其他欧洲国家
  • 亚太地区
  • 其他地区

第四章 竞赛

简介目录
Product Code: MCP34624

Global Artificial Intelligence / Machine Learning in Medical Devices Market to Reach US$14.0 Billion by 2030

The global market for Artificial Intelligence / Machine Learning in Medical Devices estimated at US$4.7 Billion in the year 2024, is expected to reach US$14.0 Billion by 2030, growing at a CAGR of 19.8% over the analysis period 2024-2030. AI / ML System / Hardware, one of the segments analyzed in the report, is expected to record a 18.2% CAGR and reach US$8.8 Billion by the end of the analysis period. Growth in the Software-As-A Medical Device segment is estimated at 22.8% CAGR over the analysis period.

The U.S. Market is Estimated at US$1.2 Billion While China is Forecast to Grow at 18.8% CAGR

The Artificial Intelligence / Machine Learning in Medical Devices market in the U.S. is estimated at US$1.2 Billion in the year 2024. China, the world's second largest economy, is forecast to reach a projected market size of US$2.2 Billion by the year 2030 trailing a CAGR of 18.8% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 18.0% and 17.3% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 14.7% CAGR.

Global Artificial Intelligence / Machine Learning in Medical Devices Market - Key Trends & Drivers Summarized

Why Are AI and Machine Learning Transforming the Performance, Utility, and Design of Medical Devices?

Artificial Intelligence (AI) and Machine Learning (ML) are redefining the capabilities of medical devices, enabling real-time data analysis, predictive diagnostics, and adaptive therapeutic interventions across multiple clinical disciplines. By embedding intelligent algorithms into hardware platforms, medical devices are evolving from passive tools into active decision-support and automation systems. AI/ML integration is now central to digital health transformation, offering enhanced clinical accuracy, workflow efficiency, and personalized care delivery.

Diagnostic devices leveraging ML can rapidly analyze imaging, waveform, or sensor data to detect anomalies, prioritize critical cases, and reduce diagnostic variability. In radiology, for instance, AI-augmented imaging systems detect early-stage tumors, classify fractures, and segment anatomical structures with precision that rivals or augments human interpretation. Meanwhile, ML-driven wearable and implantable devices continuously monitor physiological parameters-such as ECG, glucose levels, or oxygen saturation-to predict deterioration, flag outliers, and enable preemptive care interventions.

In therapeutic applications, AI algorithms support device-guided surgery, dosage optimization, and closed-loop stimulation systems. Robotic-assisted surgical platforms use ML to refine motion control and map anatomical nuances in real-time. AI-powered infusion pumps and neuromodulation devices adjust treatment regimens dynamically based on patient-specific feedback loops. As regulatory bodies approve a growing number of AI/ML-enabled software as a medical device (SaMD) solutions, intelligent device functionality is becoming a clinical imperative rather than a competitive novelty.

How Are Algorithm Validation, Data Ecosystems, and Edge AI Enhancing Adoption of AI/ML in Medical Devices?

Algorithm validation and model transparency are foundational to trust and adoption in medical AI. Developers are investing in large-scale, multi-institutional training datasets and real-world evidence (RWE) to ensure algorithm generalizability across patient demographics and clinical settings. Techniques such as federated learning and explainable AI (XAI) are gaining traction, enabling continuous model improvement without compromising data privacy or interpretability. Regulatory agencies, including the FDA, are establishing adaptive frameworks to approve ML algorithms that evolve post-deployment-supporting safer, lifecycle-managed innovation.

Data integration is further accelerating AI/ML deployment across the device landscape. Medical devices now interface with cloud platforms, hospital information systems (HIS), electronic health records (EHR), and wearable ecosystems to contextualize sensor data and enhance clinical relevance. Interoperability standards such as HL7 FHIR are facilitating cross-platform data exchange, allowing AI algorithms to draw insights from multimodal sources. These insights not only improve diagnostic and therapeutic precision but also contribute to longitudinal patient management.

Edge AI-the deployment of machine learning models directly on-device-is a critical enabler for latency-sensitive applications such as point-of-care diagnostics, portable ultrasound, or remote monitoring wearables. By minimizing reliance on continuous cloud connectivity, edge AI ensures responsiveness, data privacy, and operability in low-bandwidth or decentralized environments. Miniaturization of processors, advances in low-power computing, and embedded ML chipsets are supporting the growth of intelligent, self-contained medical devices capable of real-time autonomous decision-making.

Which Clinical Domains and Regional Markets Are Driving AI/ML Adoption in Medical Devices?

Radiology, cardiology, neurology, and oncology represent the most advanced domains in AI/ML-driven medical device adoption, owing to their high imaging intensity, data complexity, and need for diagnostic accuracy. AI-enhanced ultrasound, MRI, CT, and PET systems are being deployed in hospitals and imaging centers to automate workflows, reduce scan-to-diagnosis time, and support overburdened radiology departments. In cardiology, AI-enabled ECG monitors, wearable arrhythmia detectors, and heart failure prediction systems are improving chronic disease surveillance and risk stratification.

Surgical robotics, anesthesia monitoring, and critical care systems are incorporating ML algorithms to optimize intraoperative decisions, ventilator management, and post-operative recovery pathways. In consumer health and home care, AI-enabled devices such as smart glucometers, digital stethoscopes, and fall detection wearables are bridging gaps in continuity of care and enabling scalable chronic disease management. Dental and ophthalmic devices are also integrating AI for image analysis, procedural planning, and risk detection, expanding application boundaries.

North America dominates the AI/ML-enabled medical device landscape, driven by early regulatory approvals, strong digital health infrastructure, and a robust base of AI startups and MedTech incumbents. Europe follows closely, with emphasis on ethical AI, data privacy compliance (GDPR), and public-private innovation frameworks. The Asia-Pacific region is witnessing rapid uptake, particularly in China, Japan, South Korea, and India-where government investments, digital transformation agendas, and large untapped patient datasets are accelerating AI/ML integration. Growth in Latin America, the Middle East, and Africa is expected to be driven by mobile diagnostics, telehealth-linked devices, and public health infrastructure modernization.

How Are Regulatory Standards, Business Models, and Clinical Integration Strategies Reshaping the Competitive Landscape?

Global regulatory frameworks are evolving to accommodate the unique lifecycle of AI/ML-enabled devices. Regulatory bodies are issuing guidelines for algorithm transparency, real-world validation, and change management to address continuous learning models. The FDA’s action plan for AI/ML medical software and the EU MDR’s classification criteria are helping define pathways for safe, repeatable deployment. These frameworks are encouraging early-stage AI developers to incorporate regulatory strategy at the core of product design.

Business models are shifting toward AI-as-a-service, subscription-based analytics, and outcomes-based contracting. Device manufacturers are embedding AI modules as differentiated add-ons-offering hospitals predictive insights, workflow efficiency, and diagnostics-as-a-platform capabilities. Strategic alliances with cloud providers, EHR vendors, and clinical AI startups are enabling MedTech firms to scale AI/ML integration without rebuilding full-stack capabilities in-house. Reimbursement strategies are emerging for AI-driven diagnostics and triage tools, further supporting commercialization viability.

Successful adoption hinges on seamless clinical integration. Developers are focusing on intuitive user interfaces, clinician-in-the-loop controls, and integration with existing workflows to avoid alert fatigue or workflow disruption. Training programs, real-world case studies, and post-market surveillance systems are critical in building clinician trust and ensuring safe adoption. As competitive intensity rises, AI-enabled device differentiation is increasingly dependent on clinical relevance, interoperability, and regulatory agility rather than algorithm sophistication alone.

What Are the Factors Driving Growth in the AI/ML in Medical Devices Market?

The AI/ML in medical devices market is growing rapidly, driven by rising healthcare digitization, growing volumes of patient data, and clinical demand for precision, automation, and decision support. The convergence of computing power, data availability, and algorithm maturity is enabling medical devices to become intelligent, context-aware tools that proactively assist clinicians across diagnosis, monitoring, and treatment.

Advances in edge AI, explainable algorithms, and regulatory frameworks are making AI-enabled devices safer, more scalable, and more commercially viable. As clinical workflows demand actionable insights at the point of care, and as payers push for value-based outcomes, intelligent medical devices are aligning with broader healthcare system transformation goals.

Looking ahead, the market’s trajectory will depend on how effectively AI-enabled devices integrate into clinical decision-making, balance innovation with safety, and demonstrate measurable improvements in patient outcomes. As medical devices evolve from passive instruments to cognitive collaborators, could AI/ML define the next frontier of adaptive, personalized, and data-driven healthcare delivery?

SCOPE OF STUDY:

The report analyzes the Artificial Intelligence / Machine Learning in Medical Devices market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:

Product Type (System / Hardware, Software-As-A Medical Device); Clinical Area (Radiology, Cardiology, Hematology, Other Clinical Areas)

Geographic Regions/Countries:

World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Select Competitors (Total 34 Featured) -

  • AEYE Health
  • AliveCor
  • Atomwise
  • Behold.ai
  • BenevolentAI
  • BioSerenity
  • Butterfly Network
  • Clarius Mobile Health
  • CorticoMetrics
  • Cyclica
  • Eko Health
  • Empatica
  • Enlitic
  • Exscientia
  • GE Healthcare
  • HeartFlow
  • iCAD Inc.
  • Lantheus Holdings
  • Medtronic
  • NVIDIA

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

We are diligently following expert opinions of leading Chief Economists (14,949), Think Tanks (62), Trade & Industry bodies (171) worldwide, as they assess impact and address new market realities for their ecosystems. Experts and economists from every major country are tracked for their opinions on tariffs and how they will impact their countries.

We expect this chaos to play out over the next 2-3 months and a new world order is established with more clarity. We are tracking these developments on a real time basis.

As we release this report, U.S. Trade Representatives are pushing their counterparts in 183 countries for an early closure to bilateral tariff negotiations. Most of the major trading partners also have initiated trade agreements with other key trading nations, outside of those in the works with the United States. We are tracking such secondary fallouts as supply chains shift.

To our valued clients, we say, we have your back. We will present a simplified market reassessment by incorporating these changes!

APRIL 2025: NEGOTIATION PHASE

Our April release addresses the impact of tariffs on the overall global market and presents market adjustments by geography. Our trajectories are based on historic data and evolving market impacting factors.

JULY 2025 FINAL TARIFF RESET

Complimentary Update: Our clients will also receive a complimentary update in July after a final reset is announced between nations. The final updated version incorporates clearly defined Tariff Impact Analyses.

Reciprocal and Bilateral Trade & Tariff Impact Analyses:

USA <> CHINA <> MEXICO <> CANADA <> EU <> JAPAN <> INDIA <> 176 OTHER COUNTRIES.

Leading Economists - Our knowledge base tracks 14,949 economists including a select group of most influential Chief Economists of nations, think tanks, trade and industry bodies, big enterprises, and domain experts who are sharing views on the fallout of this unprecedented paradigm shift in the global econometric landscape. Most of our 16,491+ reports have incorporated this two-stage release schedule based on milestones.

COMPLIMENTARY PREVIEW

Contact your sales agent to request an online 300+ page complimentary preview of this research project. Our preview will present full stack sources, and validated domain expert data transcripts. Deep dive into our interactive data-driven online platform.

TABLE OF CONTENTS

I. METHODOLOGY

II. EXECUTIVE SUMMARY

  • 1. MARKET OVERVIEW
    • Influencer Market Insights
    • World Market Trajectories
    • Artificial Intelligence / Machine Learning in Medical Devices - Global Key Competitors Percentage Market Share in 2025 (E)
    • Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2025 (E)
  • 2. FOCUS ON SELECT PLAYERS
  • 3. MARKET TRENDS & DRIVERS
    • Rising Demand for Intelligent Diagnostics and Predictive Monitoring Throws the Spotlight on AI/ML Integration in Medical Devices
    • Growth in Radiology, Pathology, and Imaging Interpretation Spurs Use of Machine Learning for Automated Analysis
    • OEM Focus on Workflow Automation and Clinical Decision Support Strengthens AI Use in Healthcare Devices
    • Expansion of Wearable and Remote Monitoring Technologies Bodes Well for AI in Real-Time Health Management
    • Use of Natural Language Processing and Voice Interfaces Enhances Smart Device Usability in Clinical Settings
    • Adoption of AI in Surgical Robotics Improves Precision, Planning, and Outcome Prediction
    • Integration With EHR Systems Enables Data-Driven Personalization and Early Risk Identification
    • Growth in Patient Engagement Tools and Digital Therapeutics Supports AI for Behavioral and Chronic Condition Management
    • Investment in Explainable AI and Model Transparency Enhances Trust and Adoption Among Clinicians
  • 4. GLOBAL MARKET PERSPECTIVE
    • TABLE 1: World Artificial Intelligence / Machine Learning in Medical Devices Market Analysis of Annual Sales in US$ Million for Years 2015 through 2030
    • TABLE 2: World Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
    • TABLE 3: World 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets for Years 2025 & 2030
    • TABLE 4: World Recent Past, Current & Future Analysis for System / Hardware by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
    • TABLE 5: World 6-Year Perspective for System / Hardware by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
    • TABLE 6: World Recent Past, Current & Future Analysis for Software-As-A Medical Device by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
    • TABLE 7: World 6-Year Perspective for Software-As-A Medical Device by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
    • TABLE 8: World Recent Past, Current & Future Analysis for Radiology by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
    • TABLE 9: World 6-Year Perspective for Radiology by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
    • TABLE 10: World Recent Past, Current & Future Analysis for Cardiology by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
    • TABLE 11: World 6-Year Perspective for Cardiology by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
    • TABLE 12: World Recent Past, Current & Future Analysis for Hematology by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
    • TABLE 13: World 6-Year Perspective for Hematology by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
    • TABLE 14: World Recent Past, Current & Future Analysis for Other Clinical Areas by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
    • TABLE 15: World 6-Year Perspective for Other Clinical Areas by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030

III. MARKET ANALYSIS

  • UNITED STATES
    • Artificial Intelligence / Machine Learning in Medical Devices Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United States for 2025 (E)
    • TABLE 16: USA Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - System / Hardware and Software-As-A Medical Device - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 17: USA 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - Percentage Breakdown of Value Sales for System / Hardware and Software-As-A Medical Device for the Years 2025 & 2030
    • TABLE 18: USA Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Radiology, Cardiology, Hematology and Other Clinical Areas - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 19: USA 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Percentage Breakdown of Value Sales for Radiology, Cardiology, Hematology and Other Clinical Areas for the Years 2025 & 2030
  • CANADA
    • TABLE 20: Canada Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - System / Hardware and Software-As-A Medical Device - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 21: Canada 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - Percentage Breakdown of Value Sales for System / Hardware and Software-As-A Medical Device for the Years 2025 & 2030
    • TABLE 22: Canada Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Radiology, Cardiology, Hematology and Other Clinical Areas - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 23: Canada 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Percentage Breakdown of Value Sales for Radiology, Cardiology, Hematology and Other Clinical Areas for the Years 2025 & 2030
  • JAPAN
    • Artificial Intelligence / Machine Learning in Medical Devices Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Japan for 2025 (E)
    • TABLE 24: Japan Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - System / Hardware and Software-As-A Medical Device - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 25: Japan 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - Percentage Breakdown of Value Sales for System / Hardware and Software-As-A Medical Device for the Years 2025 & 2030
    • TABLE 26: Japan Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Radiology, Cardiology, Hematology and Other Clinical Areas - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 27: Japan 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Percentage Breakdown of Value Sales for Radiology, Cardiology, Hematology and Other Clinical Areas for the Years 2025 & 2030
  • CHINA
    • Artificial Intelligence / Machine Learning in Medical Devices Market Presence - Strong/Active/Niche/Trivial - Key Competitors in China for 2025 (E)
    • TABLE 28: China Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - System / Hardware and Software-As-A Medical Device - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 29: China 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - Percentage Breakdown of Value Sales for System / Hardware and Software-As-A Medical Device for the Years 2025 & 2030
    • TABLE 30: China Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Radiology, Cardiology, Hematology and Other Clinical Areas - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 31: China 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Percentage Breakdown of Value Sales for Radiology, Cardiology, Hematology and Other Clinical Areas for the Years 2025 & 2030
  • EUROPE
    • Artificial Intelligence / Machine Learning in Medical Devices Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Europe for 2025 (E)
    • TABLE 32: Europe Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Geographic Region - France, Germany, Italy, UK and Rest of Europe Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
    • TABLE 33: Europe 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Geographic Region - Percentage Breakdown of Value Sales for France, Germany, Italy, UK and Rest of Europe Markets for Years 2025 & 2030
    • TABLE 34: Europe Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - System / Hardware and Software-As-A Medical Device - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 35: Europe 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - Percentage Breakdown of Value Sales for System / Hardware and Software-As-A Medical Device for the Years 2025 & 2030
    • TABLE 36: Europe Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Radiology, Cardiology, Hematology and Other Clinical Areas - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 37: Europe 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Percentage Breakdown of Value Sales for Radiology, Cardiology, Hematology and Other Clinical Areas for the Years 2025 & 2030
  • FRANCE
    • Artificial Intelligence / Machine Learning in Medical Devices Market Presence - Strong/Active/Niche/Trivial - Key Competitors in France for 2025 (E)
    • TABLE 38: France Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - System / Hardware and Software-As-A Medical Device - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 39: France 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - Percentage Breakdown of Value Sales for System / Hardware and Software-As-A Medical Device for the Years 2025 & 2030
    • TABLE 40: France Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Radiology, Cardiology, Hematology and Other Clinical Areas - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 41: France 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Percentage Breakdown of Value Sales for Radiology, Cardiology, Hematology and Other Clinical Areas for the Years 2025 & 2030
  • GERMANY
    • Artificial Intelligence / Machine Learning in Medical Devices Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Germany for 2025 (E)
    • TABLE 42: Germany Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - System / Hardware and Software-As-A Medical Device - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 43: Germany 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - Percentage Breakdown of Value Sales for System / Hardware and Software-As-A Medical Device for the Years 2025 & 2030
    • TABLE 44: Germany Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Radiology, Cardiology, Hematology and Other Clinical Areas - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 45: Germany 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Percentage Breakdown of Value Sales for Radiology, Cardiology, Hematology and Other Clinical Areas for the Years 2025 & 2030
  • ITALY
    • TABLE 46: Italy Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - System / Hardware and Software-As-A Medical Device - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 47: Italy 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - Percentage Breakdown of Value Sales for System / Hardware and Software-As-A Medical Device for the Years 2025 & 2030
    • TABLE 48: Italy Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Radiology, Cardiology, Hematology and Other Clinical Areas - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 49: Italy 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Percentage Breakdown of Value Sales for Radiology, Cardiology, Hematology and Other Clinical Areas for the Years 2025 & 2030
  • UNITED KINGDOM
    • Artificial Intelligence / Machine Learning in Medical Devices Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United Kingdom for 2025 (E)
    • TABLE 50: UK Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - System / Hardware and Software-As-A Medical Device - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 51: UK 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - Percentage Breakdown of Value Sales for System / Hardware and Software-As-A Medical Device for the Years 2025 & 2030
    • TABLE 52: UK Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Radiology, Cardiology, Hematology and Other Clinical Areas - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 53: UK 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Percentage Breakdown of Value Sales for Radiology, Cardiology, Hematology and Other Clinical Areas for the Years 2025 & 2030
  • REST OF EUROPE
    • TABLE 54: Rest of Europe Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - System / Hardware and Software-As-A Medical Device - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 55: Rest of Europe 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - Percentage Breakdown of Value Sales for System / Hardware and Software-As-A Medical Device for the Years 2025 & 2030
    • TABLE 56: Rest of Europe Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Radiology, Cardiology, Hematology and Other Clinical Areas - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 57: Rest of Europe 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Percentage Breakdown of Value Sales for Radiology, Cardiology, Hematology and Other Clinical Areas for the Years 2025 & 2030
  • ASIA-PACIFIC
    • Artificial Intelligence / Machine Learning in Medical Devices Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Asia-Pacific for 2025 (E)
    • TABLE 58: Asia-Pacific Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - System / Hardware and Software-As-A Medical Device - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 59: Asia-Pacific 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - Percentage Breakdown of Value Sales for System / Hardware and Software-As-A Medical Device for the Years 2025 & 2030
    • TABLE 60: Asia-Pacific Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Radiology, Cardiology, Hematology and Other Clinical Areas - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 61: Asia-Pacific 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Percentage Breakdown of Value Sales for Radiology, Cardiology, Hematology and Other Clinical Areas for the Years 2025 & 2030
  • REST OF WORLD
    • TABLE 62: Rest of World Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - System / Hardware and Software-As-A Medical Device - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 63: Rest of World 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Product Type - Percentage Breakdown of Value Sales for System / Hardware and Software-As-A Medical Device for the Years 2025 & 2030
    • TABLE 64: Rest of World Recent Past, Current & Future Analysis for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Radiology, Cardiology, Hematology and Other Clinical Areas - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
    • TABLE 65: Rest of World 6-Year Perspective for Artificial Intelligence / Machine Learning in Medical Devices by Clinical Area - Percentage Breakdown of Value Sales for Radiology, Cardiology, Hematology and Other Clinical Areas for the Years 2025 & 2030

IV. COMPETITION