United States AI in Medical Imaging: FDA Approvals & Validation | Leading Companies likes - GE HealthCare, FUJIFILM Corporation, Koninklijke Philips NV, Aidoc

Market Size and Forecast:

The global AI in medical imaging market was valued at US$ 1.29 Billion in 2023. The market size reached US$ 1.58 Billion in 2024 and is expected to reach US$ 11.25 Billion by 2033, growing at a CAGR of 24.6% during the forecast period 2025-2033.

The AI in Medical Imaging Market report, published by DataM Intelligence, provides in-depth insights and analysis on key market trends, growth opportunities, and emerging challenges. Committed to delivering actionable intelligence, DataM Intelligence empowers businesses to make informed decisions and stay ahead of the competition. Through a combination of qualitative and quantitative research methods, it offers comprehensive reports that help clients navigate complex market landscapes, drive strategic growth, and seize new opportunities in an ever-evolving global market.

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AI in medical imaging leverages machine learning and deep learning algorithms to enhance image analysis, diagnosis, and workflow efficiency. It enables faster and more accurate detection of diseases such as cancer, cardiovascular conditions, and neurological disorders by automating image interpretation and highlighting anomalies. AI-powered imaging tools are transforming radiology by improving diagnostic precision, reducing human error, and supporting personalized treatment planning.

Recent Key Developments of United States and Japan:

USA

September 2025: GE HealthCare acquired Icometrix, a company specializing in AI-powered brain imaging analysis, aimed at enhancing GE's neurology portfolio and specifically monitoring anti-amyloid therapies for Alzheimer's disease.

July 14, 2025: The FDA published a regulatory update listing 211 newly authorized AI-enabled medical devices since September 2024, with Radiology accounting for approximately 81% of the total, underscoring the rapid and continuous commercialization of AI tools for image processing and risk prediction.

Japan

Ongoing Regulatory Trend (Jul-Sept 2025): The full-scale operation of Japan's Nationwide Medical Information Platform was scheduled for Fiscal Year 2025, an initiative that will enhance data-sharing and accelerate the clinical and regulatory review process for AI imaging solutions that rely on large, diverse datasets.

Ongoing Trend (Jul-Sept 2025): Japanese regulatory bodies (PMDA/MHLW) continued to streamline approval pathways for Software as a Medical Device (SaMD), including AI tools, by using fast-track and two-step approval models to quickly introduce innovative diagnostics while requiring ongoing post-market evidence.

List of the Key Players in the AI in Medical Imaging Market:

GE HealthCare
FUJIFILM Corporation
Koninklijke Philips NV
Aidoc
Blackford Analysis
Siemens Healthineers AG
Canon Medical Systems GmbH
Qure.ai
NVIDIA Corporation
SARC MedIQ

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This Report Covers:

✔ Go-to-market Strategy.

✔ Neutral perspective on the market performance.

✔Development trends, competitive landscape analysis, supply side analysis, demand side analysis, year-on-year growth, competitive benchmarking, vendor identification, and other significant analysis, as well as development status.

✔Customized regional/country reports as per request and country level analysis.

✔ Potential & niche segments and regions exhibiting promising growth covered.

✔ Analysis of Market Size (historical and forecast), Total Addressable Market (TAM), Serviceable Available Market (SAM), Serviceable Obtainable Market (SOM), Market Growth, Technological Trends, Market Share, Market Dynamics, Competitive Landscape and Major Players (Innovators, Start-ups, Laggard, and Pioneer).

Segments Covered in the AI in Medical Imaging Market:

➥ By Modality: X-ray Imaging, Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Ultrasound Imaging, Mammography, Others
➥ By Diagnosis Type: Cloud-Based Solutions, On-Premise Solutions, Hybrid Models
➥ By Component: Software, Hardware, Services

Regional Analysis:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, AI in Medical Imaging Market market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global AI in Medical Imaging Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The Global AI in Medical Imaging Market leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the AI in Medical Imaging Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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People Also Ask:

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◆ Which region is expected to dominate the industry during the forecast period?

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