The global hybrid PET MRI systems market size was valued at USD 473.9 million in 2025 and is projected to grow from USD 485.8 million in 2026 to USD 599.4 million by 2033, at a CAGR of 3.0% from 2026 to 2033. North America dominated the market, accounting for the revenue share of 41.3% in 2025. The industry is experiencing strong growth, driven by the increasing adoption of advanced multimodal imaging technologies, rising demand for precise and early disease diagnosis, and growing applications in oncology, neurology, and cardiology.
Hybrid PET/MRI (positron emission tomography/magnetic resonance imaging) systems combine simultaneous functional and anatomical imaging in a single examination, a capability the FDA classifies as a Class II medical device under 21 CFR 892.1200, product code OUO. Since the first U.S. clearance in 2011, fourteen PET/MR systems have received FDA 510(k) clearance, spanning four manufacturers. Over the same period, federal health agencies have tracked a growing burden of the two disease categories. PET/MR is most often used to evaluate cancer and neurodegenerative disease, while CMS has progressively simplified Medicare’s coverage rules for PET-based diagnosis.
The National Cancer Institute’s SEER Program, the U.S. government’s authoritative source for population-based cancer statistics, projected 2,041,910 new cancer cases and 618,120 cancer deaths in the United States in 2025 across all sites. Within that total, several specific cancer types carry particular relevance to PET/MR: brain and other nervous-system cancers, where SEER projected 24,820 new cases and 18,330 deaths in 2025, with 187,162 Americans living with a brain or CNS cancer diagnosis as of 2022; and the two most commonly diagnosed solid tumors, female breast cancer (316,950 new cases, 42,170 deaths) and prostate cancer (313,780 new cases, 35,770 deaths) in 2025. PET/MR’s ability to fuse metabolic activity with high-resolution soft-tissue anatomy is particularly suited to brain tumor delineation and to monitoring treatment response in cancers where sequential PET and MRI exams were previously required.
On the neurology side, CDC’s National Center for Health Statistics recorded Alzheimer’s disease as the sixth-leading cause of death in the United States across all ages in 2023, with 114,034 recorded deaths, a burden that continues to grow as the U.S. population ages. Emerging Alzheimer’s drug therapies increasingly rely on PET imaging to confirm diagnosis before treatment and on MR imaging to monitor for treatment-related side effects. A combination hybrid PET/MR performs in a single simultaneous session rather than two separate appointments.
Because the FDA’s 510(k) database records the applicant on every clearance, it is possible to build a complete, non-proprietary picture of which companies have brought hybrid PET/MR systems to the U.S. market and how often.
Siemens Healthineers (filing under both Siemens Medical Solutions U.S. and, most recently, Siemens Healthineers AG) holds six of the fourteen clearances on record, the most of any applicant. Its clearance history begins with the Biograph mMR (K103429, 2011) and continues through several hardware and software updates to that platform (K133226 in 2013, K163234 in 2017, K172531 in 2017, K200213 in 2020) before culminating in the Biograph One (K253023), a second-generation PET/MR platform cleared in January 2026 the most recent filing in the category and Siemens’ first ground-up PET/MR refresh since the original Biograph mMR fourteen years earlier.
Shanghai United Imaging Healthcare holds four clearances, all under the same device name, uPMR 790, filed in February 2019, November 2019, November 2022, and May 2024, a cadence suggesting iterative updates to a single platform rather than a new product line each time. GE Medical Systems (doing business as GE HealthCare) holds three clearances for its SIGNA PET/MR system, filed in November 2014, February 2017, and January 2022. Philips Healthcare (Cleveland) holds a single clearance, the Ingenuity TF PET/MR (K103483), cleared in November 2011 alongside Siemens’ original Biograph mMR and not updated in the FDA’s OUO record since.
Hybrid PET/MRI (positron emission tomography/magnetic resonance imaging) systems combine simultaneous functional and anatomical imaging in a single examination, a capability the FDA classifies as a Class II medical device under 21 CFR 892.1200, product code OUO. Since the first U.S. clearance in 2011, fourteen PET/MR systems have received FDA 510(k) clearance, spanning four manufacturers. Over the same period, federal health agencies have tracked a growing burden of the two disease categories. PET/MR is most often used to evaluate cancer and neurodegenerative disease, while CMS has progressively simplified Medicare’s coverage rules for PET-based diagnosis.
The National Cancer Institute’s SEER Program, the U.S. government’s authoritative source for population-based cancer statistics, projected 2,041,910 new cancer cases and 618,120 cancer deaths in the United States in 2025 across all sites. Within that total, several specific cancer types carry particular relevance to PET/MR: brain and other nervous-system cancers, where SEER projected 24,820 new cases and 18,330 deaths in 2025, with 187,162 Americans living with a brain or CNS cancer diagnosis as of 2022; and the two most commonly diagnosed solid tumors, female breast cancer (316,950 new cases, 42,170 deaths) and prostate cancer (313,780 new cases, 35,770 deaths) in 2025. PET/MR’s ability to fuse metabolic activity with high-resolution soft-tissue anatomy is particularly suited to brain tumor delineation and to monitoring treatment response in cancers where sequential PET and MRI exams were previously required.
On the neurology side, CDC’s National Center for Health Statistics recorded Alzheimer’s disease as the sixth-leading cause of death in the United States across all ages in 2023, with 114,034 recorded deaths, a burden that continues to grow as the U.S. population ages. Emerging Alzheimer’s drug therapies increasingly rely on PET imaging to confirm diagnosis before treatment and on MR imaging to monitor for treatment-related side effects. A combination hybrid PET/MR performs in a single simultaneous session rather than two separate appointments.
Because the FDA’s 510(k) database records the applicant on every clearance, it is possible to build a complete, non-proprietary picture of which companies have brought hybrid PET/MR systems to the U.S. market and how often.
Siemens Healthineers (filing under both Siemens Medical Solutions U.S. and, most recently, Siemens Healthineers AG) holds six of the fourteen clearances on record, the most of any applicant. Its clearance history begins with the Biograph mMR (K103429, 2011) and continues through several hardware and software updates to that platform (K133226 in 2013, K163234 in 2017, K172531 in 2017, K200213 in 2020) before culminating in the Biograph One (K253023), a second-generation PET/MR platform cleared in January 2026 the most recent filing in the category and Siemens’ first ground-up PET/MR refresh since the original Biograph mMR fourteen years earlier.
Shanghai United Imaging Healthcare holds four clearances, all under the same device name, uPMR 790, filed in February 2019, November 2019, November 2022, and May 2024, a cadence suggesting iterative updates to a single platform rather than a new product line each time. GE Medical Systems (doing business as GE HealthCare) holds three clearances for its SIGNA PET/MR system, filed in November 2014, February 2017, and January 2022. Philips Healthcare (Cleveland) holds a single clearance, the Ingenuity TF PET/MR (K103483), cleared in November 2011 alongside Siemens’ original Biograph mMR and not updated in the FDA’s OUO record since.
Global Hybrid PET MRI Systems Market Report Segmentation
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, the analyst has segmented the global hybrid PET MRI systems market report based on type, application, end-use, and region:Type Outlook (Revenue, USD Million, 2021 - 2033)
- Traditional PET-MRI systems
- Helium-free PET-MRI systems
Application Outlook (Revenue, USD Million, 2021 - 2033)
- Oncology
- Neurology
- Cardiovascular
- Musculoskeletal
- Others
End-use Outlook (Revenue, USD Million, 2021 - 2033)
- Hospitals
- Diagnostic Imaging Centers
- Ambulatory Surgery Centers
- Specialty Clinics & Cath Labs
- Academic & Research Institutes
Regional Outlook (Revenue, USD Million, 2021 - 2033)
- North America
- U.S.
- Canada
- Mexico
- Europe
- UK
- Germany
- France
- Italy
- Spain
- Denmark
- Sweden
- Norway
- Asia Pacific
- China
- Japan
- South Korea
- India
- Australia
- Thailand
- Latin America
- Brazil
- Argentina
- MEA
- Saudi Arabia
- South Africa
- UAE
- Kuwait
Why should you buy this report?
- Comprehensive Market Analysis: Gain detailed insights into the market across major regions and segments.
- Competitive Landscape: Explore the market presence of key players.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
- Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.
This report addresses:
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segment and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listing for you to stay ahead of the curve
Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. Hybrid PET MRI Systems Market Variables, Trends & Scope
Chapter 4. Hybrid PET MRI Systems Market: Type Estimates & Trend Analysis
Chapter 5. Hybrid PET MRI Systems Market: Application Estimates & Trend Analysis
Chapter 6. Hybrid PET MRI Systems Market: End use Estimates & Trend Analysis
Chapter 7. Hybrid PET MRI Systems Market: Regional Estimates & Trend Analysis
Chapter 8. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
- Siemens Healthineers
- GE HealthCare
- Koninklijke Philips N.V.
- United Imaging Healthcare
- Bruker Corporation
- Mediso Ltd.
- MR Solutions
- Canon Medical Systems Corporation
- Cubresa Inc.
- Molecubes
