医療機器における人工知能／機械学習の世界市場

医療機器における人工知能／機械学習の世界市場は2030年までに140億米ドルに達する見込み

2024年に47億米ドルと推定される医療機器における人工知能／機械学習の世界市場は、2024年から2030年にかけてCAGR 19.8%で成長し、2030年には140億米ドルに達すると予測されます。本レポートで分析したセグメントの1つであるAI/MLシステム/ ハードウェアは、CAGR 18.2%を記録し、分析期間終了までに88億米ドルに達すると予測されます。Software-As-A医療機器セグメントの成長率は、分析期間でCAGR 22.8％と推定されます。

米国市場は12億米ドルと推定、中国はCAGR18.8％で成長予測

米国の医療機器における人工知能／機械学習市場は2024年に12億米ドルと推定されます。世界第2位の経済大国である中国は、2030年までに22億米ドルの市場規模に達すると予測され、分析期間2024-2030年のCAGRは18.8%です。その他の注目すべき地域別市場としては、日本とカナダがあり、分析期間中のCAGRはそれぞれ18.0％と17.3％と予測されています。欧州では、ドイツがCAGR約14.7%で成長すると予測されています。

世界の医療機器における人工知能／機械学習市場- 主要動向と促進要因まとめ

なぜAIと機械学習が医療機器の性能、実用性、設計を変革するのか？

人工知能（AI）と機械学習（ML）は、医療機器の機能を再定義し、複数の臨床分野にわたるリアルタイムのデータ分析、予測診断、適応的な治療介入を可能にしています。インテリジェントなアルゴリズムをハードウェア・プラットフォームに組み込むことで、医療機器は受動的なツールから能動的な意思決定支援システムや自動化システムへと進化しています。AI/MLの統合は今やデジタルヘルス変革の中心であり、臨床精度の向上、ワークフローの効率化、個別化されたケアの提供を実現します。

MLを活用した診断機器は、画像、波形、センサーデータを迅速に分析し、異常を検出し、重要な症例に優先順位を付け、診断のばらつきを減らすことができます。例えば放射線診断では、AIを活用した画像処理システムが、人間拡張に匹敵する精度で早期の腫瘍を検出し、骨折を分類し、解剖学的構造をセグメント化します。一方、MLを活用したウェアラブルデバイスや埋め込み型デバイスは、心電図、グルコースレベル、酸素飽和度などの生理学的パラメータを継続的に監視し、悪化を予測したり、異常値にフラグを立てたり、先手を打ったケア介入を可能にします。

治療アプリケーションでは、AIアルゴリズムがデバイス誘導手術、投与量の最適化、閉ループ刺激システムをサポートします。ロボット支援手術プラットフォームは、MLを使用して動作制御を改良し、解剖学的なニュアンスをリアルタイムでマッピングします。AIを搭載した輸液ポンプや神経調節装置は、患者固有のフィードバックループに基づいて治療レジメンを動的に調整します。規制当局がAI/ML対応の医療機器としてのソフトウェア（SaMD）ソリューションを承認する数が増えるにつれ、インテリジェント機器の機能は競合の目新しさではなく、臨床上の必須事項になりつつあります。

アルゴリズム検証、データエコシステム、エッジAIは、医療機器におけるAI/MLの採用をどのように促進しているのか？

アルゴリズムの検証とモデルの透明性は、医療用AIの信頼と採用の基礎となります。開発者は、患者の属性や臨床環境におけるアルゴリズムの汎用性を確保するために、大規模で多施設のトレーニングデータセットや実世界のエビデンス（RWE）に投資しています。連携学習や説明可能なAI（XAI）などの技術は、データのプライバシーや解釈可能性を損なうことなく継続的なモデルの改善を可能にし、人気を集めています。FDAを含む規制機関は、導入後に進化するMLアルゴリズムを承認する適応フレームワークを確立しつつあり、より安全でライフサイクル管理されたイノベーションをサポートしています。

データ統合は、医療機器全体におけるAI/MLの展開をさらに加速させています。医療機器は現在、クラウドプラットフォーム、病院情報システム（HIS）、電子カルテ（EHR）、ウェアラブルエコシステムと連携し、センサーデータを文脈化して臨床との関連性を高めています。HL7 FHIRのような相互運用性標準は、クロスプラットフォームのデータ交換を促進し、AIアルゴリズムがマルチモーダルなソースから洞察を引き出せるようにしています。これらの洞察は診断や治療の精度を向上させるだけでなく、長期的な患者管理にも貢献します。

エッジAI（デバイス上で機械学習モデルを直接展開すること）は、ポイントオブケア診断、ポータブル超音波、遠隔モニタリング用ウェアラブルなど、遅延の影響を受けやすいアプリケーションにとって重要な実現手段です。継続的なクラウド接続への依存を最小限に抑えることで、エッジAIは低帯域幅や分散化された環境での応答性、データプライバシー、操作性を確保します。プロセッサの小型化、低消費電力コンピューティングの進歩、組み込み型MLチップセットが、リアルタイムの自律的意思決定が可能なインテリジェントな自己完結型医療機器の成長を支えています。

医療機器におけるAI/ML採用を牽引している臨床領域と地域市場は？

放射線学、心臓病学、神経学、腫瘍学は、高い画像強度、データの複雑さ、診断精度の必要性から、AI/ML主導の医療機器採用において最も先進的な領域を代表しています。AIを活用した超音波、MRI、CT、PETシステムは、ワークフローを自動化し、スキャンから診断までの時間を短縮し、負担の大きい放射線科をサポートするために、病院や画像診断センターに導入されています。循環器科では、AI対応の心電図モニター、ウェアラブル不整脈検出器、心不全予測システムが、慢性疾患の監視とリスク層別化を改善しています。

手術ロボット、麻酔モニタリング、重症患者ケアシステムでは、MLアルゴリズムを組み込んで、術中の意思決定、人工呼吸器管理、術後の回復経路を最適化しています。コンシューマーヘルスとホームケアでは、スマート・グルコメーター、デジタル聴診器、転倒検知ウェアラブルなどのAI対応機器が、ケアの継続性におけるギャップを埋め、拡張可能な慢性疾患管理を可能にしています。歯科機器や眼科機器も、画像分析、処置計画、リスク検出のためにAIを統合しており、アプリケーションの境界を広げています。

北米は、AI/ML対応医療機器の展望を支配しており、これは早期規制承認、強力なデジタルヘルスインフラストラクチャ、AI新興企業および医療技術既存企業の強固な基盤に後押しされています。欧州は、倫理的なAI、データ・プライバシーのコンプライアンス（GDPR）、官民イノベーションの枠組みを重視し、これに続いています。アジア太平洋地域は、特に中国、日本、韓国、インドで急速な普及が見られ、政府投資、デジタルトランスフォーメーションの課題、未開拓の大規模な患者データセットがAI/ML統合を加速させています。ラテンアメリカ、中東・アフリカでの成長は、モバイル診断、遠隔医療連携機器、公衆衛生インフラの近代化によって牽引されると予想されます。

規制基準、ビジネスモデル、臨床統合戦略は競合情勢をどのように変えているか？

世界の規制枠組みは、AI/ML対応機器のユニークなライフサイクルに対応するよう進化しています。規制機関は、アルゴリズムの透明性、実環境での検証、継続的学習モデルに対応するための変更管理に関するガイドラインを発行しています。FDAのAI/ML医療ソフトウェアの行動計画やEU MDRの分類基準は、安全で反復可能な展開のための道筋を定義するのに役立っています。これらの枠組みは、初期段階のAI開発者が製品設計の中核に規制戦略を組み込むことを促しています。

ビジネスモデルは、AIアズ・ア・サービス、サブスクリプション・ベースの分析、アウトカムベースの契約へとシフトしています。機器メーカーは、差別化されたアドオンとしてAIモジュールを組み込み、病院に対して予測的洞察、ワークフローの効率化、プラットフォームとしての診断機能を提供しています。クラウドプロバイダー、EHRベンダー、臨床AI新興企業との戦略的提携により、MedTech企業は社内でフルスタック機能を再構築することなく、AI/ML統合を拡大できるようになっています。AI主導の診断やトリアージ・ツールに対する償還戦略が登場し、商業化の実行可能性をさらに後押ししています。

導入の成功は、シームレスな臨床統合にかかっています。開発者は、直感的なユーザーインターフェイス、臨床医によるインザループコントロール、アラート疲労やワークフローの中断を避けるための既存ワークフローとの統合に注力しています。臨床医の信頼を築き、安全な導入を確保するためには、トレーニングプログラム、実際の症例研究、市販後の監視システムが不可欠です。競争激化に伴い、AI対応機器の差別化は、アルゴリズムの洗練度だけでなく、臨床との関連性、相互運用性、規制当局の機敏性にますます依存するようになっています。

医療機器におけるAI/ML市場の成長を促進する要因とは？

医療機器におけるAI/ML市場は、ヘルスケアのデジタル化の進展、患者データの増大、精度、自動化、意思決定支援に対する臨床需要に牽引され、急速に成長しています。コンピューティング能力、データの可用性、アルゴリズムの成熟度の融合により、医療機器は診断、モニタリング、治療にわたって臨床医を積極的に支援するインテリジェントでコンテキストを意識したツールになりつつあります。

エッジAI、説明可能なアルゴリズム、規制フレームワークの進歩により、AI対応機器の安全性、拡張性、商業的実現性が高まっています。臨床ワークフローが診療時点における実用的な洞察を求め、支払者が価値ベースのアウトカムを推進する中、インテリジェント医療機器はより広範なヘルスケアシステム変革の目標に合致しつつあります。

今後、AI対応機器がいかに効果的に臨床の意思決定に統合され、イノベーションと安全性のバランスが取れ、患者の転帰において測定可能な改善を実証できるかにかかっています。医療機器が受動的な機器から認知的な協力者へと進化する中で、AI/MLは適応的で個別化されたデータ主導のヘルスケア提供の次のフロンティアを定義することができるだろうか。

セグメント

製品タイプ（システム／ハードウェア、医療機器としてのソフトウェア）;臨床分野（放射線学、心臓病学、血液学、その他の臨床分野）

調査対象企業の例（全34社）

• 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

関税影響係数

Global Industry Analystsは、本社の国、製造拠点、輸出入（完成品とOEM）に基づく企業の競争力の変化を予測しています。この複雑で多面的な市場力学は、人為的な売上原価の増加、収益性の低下、サプライチェーンの再構築など、ミクロおよびマクロの市場力学の中でも特に競合他社に影響を与える見込みです。

Global Industry Analystsは、世界の主要なチーフ・エコノミスト（1万4,949人）、シンクタンク（62団体）、貿易・産業団体（171団体）の専門家の意見に熱心に従いながら、エコシステムへの影響を評価し、新たな市場の現実に対処しています。あらゆる主要国の専門家やエコノミストが、関税とそれが自国に与える影響についての意見を追跡調査しています。

Global Industry Analystsは、この混乱が今後2-3ヶ月で収束し、新しい世界秩序がより明確に確立されると予想しています。Global Industry Analystsは、これらの開発をリアルタイムで追跡しています。

2025年4月：交渉フェーズ

4月のリリースでは、世界市場全体に対する関税の影響を取り上げ、地域別の市場調整について紹介します。当社の予測は、過去のデータと進化する市場影響要因に基づいています。

2025年7月：最終関税リセット

お客様には、各国間で最終リセットが発表された後、7月に無料アップデート版をお届けします。最終アップデート版には、明確に定義された関税影響分析が組み込まれています。

相互および二国間貿易と関税の影響分析：

アメリカ <>中国<>メキシコ <>カナダ <>EU <>日本<>インド <>その他176カ国

業界をリードするエコノミスト：Global Industry Analystsの知識ベースは、国家、シンクタンク、貿易・業界団体、大企業、そして世界の計量経済状況におけるこの前例のないパラダイムシフトの影響を共有する領域の専門家など、最も影響力のあるチーフエコノミストを含む1万4,949人のエコノミストを追跡しています。我々の16,491以上のレポートのほとんどは、マイルストーンに基づくこの2段階のリリーススケジュールを取り入れています。

目次

第1章 調査手法

第2章 エグゼクティブサマリー

• 市場概要
• 主要企業
• 市場動向と促進要因
• 世界市場の見通し

第3章 市場分析

• 米国
• カナダ
• 日本
• 中国
• 欧州
• フランス
• ドイツ
• イタリア
• 英国
• その他欧州
• アジア太平洋
• その他の地域

第4章 競合

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