AI-Powered Imaging Diagnostics Market is expected to reach US$ 9.73 billion by 2033 | Top Key players - Deepc GmbH, Tempus AI, Inc., Rayscape

Market Size and Growth:

The Global AI-Powered Imaging Diagnostics Market Size reached US$ 1.61 billion in 2024 and is expected to reach US$ 9.73 billion by 2033, growing at a CAGR of 22.3% during the forecast period 2025-2033. The Market is growing due to increasing adoption of AI in healthcare for faster, more accurate diagnostics and rising demand for advanced imaging technologies. According to DataM Intelligence Report.

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The AI-Powered Imaging Diagnostics Market refers to the sector focused on using artificial intelligence technologies to analyze medical images, such as X-rays, MRIs, and CT scans, for faster and more accurate disease detection. It enhances diagnostic efficiency, reduces human error, supports clinical decision-making, and drives innovation in healthcare imaging through advanced algorithms and machine learning solutions.

Industry Recent Developments: United States

✅ November 2025: Zebra Medical Vision launched a new AI-powered imaging diagnostic platform for radiology that offers automated detection of critical conditions, integrating with existing PACS systems for hospitals and diagnostic centers.

✅ October 2025: Aidoc introduced an AI solution targeting emergency imaging, focusing on stroke and pulmonary embolism detection, backed by $15 million in venture funding to improve workflow efficiency.

✅ September 2025: The U.S. AI diagnostics market is rapidly growing due to demand for early disease detection, tech advances in AI and imaging, shortage of skilled radiologists, and telemedicine integration improving diagnostic access and speed.

Industry Recent Developments: Japan

✅ September 2025: Japan released "Curia," a large multi-modal AI foundation model trained on over 150,000 cross-sectional imaging exams, enabling advanced organ identification, hemorrhage detection, and AI-supported tumor staging.

✅ June 2025: Terumo signed a distribution agreement to market AutocathFFR, an AI-based FFR software as a medical device for coronary diagnostics, with sales starting in October 2025, advancing AI clinical adoption in catheterization labs.

✅ March 2025: AI Medical Service showcased its approved endoscopic AI for gastrointestinal lesion detection at Expo 2025 Osaka, highlighting advances in AI-driven real-time diagnostic imaging.

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FDA Approvals / Regulatory Milestones in 2025:

Tempus AI:

✅ The company received FDA 510(k) clearance for its Tempus Pixel platform in September 2025, which is an AI-powered cardiac MR imaging tool. The update enables the generation of T1 and T2 inline maps from raw MRI data - helping detect fibrosis, inflammation, edema even on scanners that do not natively support those maps.

✅ In July 2025, Tempus also got 510(k) clearance for another AI tool, Tempus ECG‐Low EF, which analyses resting 12‐lead ECGs to detect low left ventricular ejection fraction (≤ 40 %).

GE HealthCare:

✅ The FDA cleared GE's Revolution Vibe CT system under 510(k) (K250941). This is a CT imaging system (CT X-ray) - not strictly AI-diagnostic software, but the system is part of GE's broader imaging portfolio.

✅ More broadly, GE HealthCare has claimed continued leadership in FDA AI authorizations: according to them, they have reached 100 AI‐enabled medical device authorizations to date.

Aidoc:

✅ On 30 September 2025, the FDA granted Breakthrough Device Designation to Aidoc's multi‐triage AI solution for CT imaging.

✅ This is significant: the solution is powered by their "CARE" foundation model (aiOSTM), and the designation covers multiple life-threatening, time-sensitive conditions in a single workflow.

Warning / Regulatory Risk:

✅ There was a notable FDA Warning Letter (reported earlier in 2025) about GMP (Good Manufacturing Practice) compliance for an AI-enabled diagnostic device - highlighting risks for AI/ML developers around quality systems.

Mergers & Acquisitions / Strategic Moves in 2025:

GE HealthCare → Intelerad Acquisition:

✅ In November 2025, GE HealthCare agreed to acquire Intelerad (a medical imaging software + enterprise workflow provider) for US$ 2.3 billion in cash.

✅ The deal is framed as a move to accelerate GE's cloud-first, AI‐enabled imaging strategy across outpatient, hospital, and teleradiology settings.

✅ GE estimates that Intelerad will generate ~US$ 270 million in revenue in the first full year post-acquisition, ~90% recurring.

✅ The transaction is expected to close in the first half of 2026, subject to regulatory approvals.

GE HealthCare → icometrix Acquisition (Intent):

✅ In September 2025, GE announced an intent to acquire icometrix, a company specialized in AI-powered brain MRI analysis.

✅ icometrix's icobrain platform includes "icobrain aria," which is FDA 510(k)-cleared for detecting/quantifying Amyloid-Related Imaging Abnormalities (ARIA) - side‐effects seen in Alzheimer's therapy.

✅ The acquisition is aligned with GE's "precision care" strategy in neurology, integrating AI analysis with their MRI systems.

Major Key Players:

Deepc GmbH
Qure.ai Technologies Private Limited
DeepTek.ai, Inc
Koninklijke Philips N.V.
Tempus AI, Inc.
Rayscape
Infervision
AIKENIST
Rad AI
Brainomix Limited

Segments Covered in the AI-Powered Imaging Diagnostics Market:

By Component: Software, Hardware, Services.

By Imaging Modality: Computed Tomography (CT), X-Ray Imaging, Magnetic Resonance Imaging (MRI), Ultrasound Imaging, Mammography, Positron Emission Tomography (PET), Others.

By Application: Radiology, Cardiology, Ophthalmology, Oncology, Neurology, Orthopedic, Dentistry, Others.

By End-User: Hospitals, Specialty Clinics, Diagnostic Centers, Research & Academic Institutes, Others.

Regional Analysis for AI-Powered Imaging Diagnostics Market:

⇥ 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-Powered Imaging Diagnostics market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global AI-Powered Imaging Diagnostics 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-Powered Imaging Diagnostics market's 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-Powered Imaging Diagnostics 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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Frequently asked questions:

➠ What is the global sales value, production value, consumption value, import and export of AI-Powered Imaging Diagnostics market?

➠ Who are the global key manufacturers of the AI-Powered Imaging Diagnostics Industry? How is their operating situation (capacity, production, sales, price, cost, gross, and revenue)?

➠ What are the AI-Powered Imaging Diagnostics market opportunities and threats faced by the vendors in the global AI-Powered Imaging Diagnostics Industry?

➠ Which application/end-user or product type may seek incremental growth prospects? What is the market share of each type and application?

➠ What focused approach and constraints are holding the AI-Powered Imaging Diagnostics market?

➠ What are the different sales, marketing, and distribution channels in the global industry?

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