North America Electrophysiology Devices Market Size 2024
USD 6,082.68 million
North America Electrophysiology Devices Market, CAGR
14.9%
North America Electrophysiology Devices Market Size 2032
USD 18,449.34 million
Market Overview
North America Electrophysiology Devices Market size was valued at USD 3,624.07 million in 2018 to USD 6,082.68 million in 2024 and is anticipated to reach USD 18,449.34 million by 2032, at a CAGR of 14.9% during the forecast period.
Rising incidence of cardiovascular diseases and a growing geriatric population are key drivers accelerating demand for electrophysiology devices in North America. The market benefits from strong investments in healthcare infrastructure, early adoption of advanced diagnostic and ablation technologies, and a well-established reimbursement framework that encourages minimally invasive procedures. Increasing awareness among healthcare professionals and patients about early arrhythmia detection and treatment is fueling rapid market expansion. Integration of artificial intelligence and remote monitoring solutions is reshaping clinical workflows, allowing for greater accuracy in diagnosis and personalized care. Strategic partnerships, mergers, and acquisitions among leading medical device manufacturers are further intensifying innovation and expanding product portfolios. Collectively, these trends position North America at the forefront of the global electrophysiology devices market, with technological advancements and robust healthcare investments sustaining momentum and fostering new growth opportunities across the region.
The North America Electrophysiology Devices Market demonstrates strong performance across the United States, Canada, and Mexico, with the U.S. serving as the primary hub for technological innovation and adoption of advanced cardiac care solutions. Canada contributes to regional growth through its commitment to high-quality healthcare access and progressive adoption of minimally invasive electrophysiology techniques, while Mexico is making strides by expanding cardiac care infrastructure and increasing awareness about arrhythmia management. Key players shaping the competitive landscape include Boston Scientific Corp., Medtronic, and Abbott, each maintaining a robust portfolio of electrophysiology devices and investing heavily in research, product development, and physician training. Biosense Webster, a division of Johnson & Johnson, also plays a significant role, driving innovation in mapping and ablation technologies. These companies collectively influence regional standards, setting benchmarks for quality and performance in electrophysiology care across North America.
Market Insights
The North America Electrophysiology Devices Market is valued at USD 6,082.68 million in 2024 and projected to reach USD 18,449.34 million by 2032, registering a CAGR of 14.9%.
Escalating prevalence of cardiovascular diseases and a growing geriatric population are key drivers supporting rapid market expansion.
The market is experiencing a shift toward minimally invasive, catheter-based procedures and widespread integration of digital health and artificial intelligence technologies.
Leading companies such as Boston Scientific Corp., Medtronic, Abbott, and Biosense Webster invest in R&D, strategic collaborations, and clinical training to maintain competitive advantage.
High costs of advanced devices and procedures, along with workforce shortages and complex regulatory pathways, act as significant restraints for smaller healthcare providers and limit adoption in certain regions.
The United States dominates the regional landscape with advanced healthcare infrastructure and robust adoption of new technologies, while Canada and Mexico focus on expanding access and modernizing cardiac care facilities.
Industry growth is propelled by strategic alliances, continuous product innovation, and a strong emphasis on improving patient outcomes across diverse healthcare systems in North America.
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Escalating Prevalence of Cardiovascular Diseases and Aging Population Fueling Demand
The North America Electrophysiology Devices Market benefits from the rising burden of cardiovascular diseases, including atrial fibrillation and other arrhythmias, across the region. The steady increase in the geriatric population—more prone to heart rhythm disorders—creates a large patient pool requiring advanced diagnostics and interventions. Growing awareness about the risks of untreated arrhythmias leads to earlier and more frequent diagnoses, driving the adoption of electrophysiology devices. Hospitals and clinics are witnessing higher patient volumes seeking both diagnostic and therapeutic procedures, stimulating the need for state-of-the-art equipment. This demographic shift, coupled with lifestyle-related factors such as obesity and hypertension, continues to fuel sustained market demand. The region’s robust disease surveillance and preventive healthcare programs contribute to early detection and intervention, reinforcing the need for electrophysiology devices.
For instance, atrial fibrillation affects approximately 6 million people in the United States, with projections indicating a rise to 12.1 million by 2030.
Technological Advancements and Innovation Driving Market Expansion
Continuous technological innovation remains a critical driver in the North America Electrophysiology Devices Market. Introduction of next-generation mapping systems, advanced ablation catheters, and real-time 3D imaging solutions enhances precision in both diagnosis and treatment. Device manufacturers prioritize research and development to improve the safety, efficacy, and usability of electrophysiology products. Integration of artificial intelligence and digital platforms further supports clinical decision-making, allowing for personalized patient care. Hospitals seek to upgrade their existing infrastructure to keep pace with the latest advancements, creating strong demand for new device installations. These innovations help reduce procedure times, improve patient outcomes, and streamline clinical workflows, solidifying the market’s growth trajectory.
For instance, the adoption of robotic-assisted electrophysiology procedures has increased by 45%, improving procedural precision and patient outcomes.
Favorable Reimbursement Policies and Supportive Regulatory Environment
The North America Electrophysiology Devices Market benefits from a well-established reimbursement framework, making advanced procedures more accessible to a broader patient base. Private insurers and public healthcare programs cover a wide range of electrophysiology interventions, reducing out-of-pocket expenses for patients. Regulatory agencies in the region maintain clear guidelines and efficient approval pathways, supporting rapid introduction of innovative devices. This supportive environment accelerates product launches and market entry for new technologies. Streamlined regulatory processes enable quicker adoption of breakthrough solutions, ensuring healthcare providers can offer the latest treatments. The combined impact of reimbursement and regulation strengthens overall market confidence and encourages ongoing investment.
Strategic Collabjorations and Healthcare Infrastructure Investments
Leading industry players pursue strategic partnerships, mergers, and acquisitions to expand product portfolios and geographic reach in the North America Electrophysiology Devices Market. Collaborative efforts between hospitals, research institutes, and device manufacturers support development and deployment of cutting-edge technologies. Investments in expanding healthcare infrastructure—including new cardiac centers and specialized electrophysiology labs—enhance patient access to advanced care. Governments and private sector stakeholders allocate significant resources toward modernizing facilities and training specialized personnel. These strategic initiatives help ensure rapid market growth, strengthen clinical capabilities, and position the region at the forefront of global electrophysiology innovation.
Market Trends
Adoption of Minimally Invasive and Catheter-Based Procedures Transforming Clinical Practice
Healthcare providers across the North America Electrophysiology Devices Market are shifting preference toward minimally invasive, catheter-based procedures for arrhythmia diagnosis and treatment. Hospitals and clinics seek devices that offer shorter recovery times, fewer complications, and enhanced patient comfort. Innovations in catheter design and navigation systems now allow for greater procedural accuracy and reduced procedure durations. Patients show growing interest in non-surgical solutions, fueling broader acceptance of these technologies. This trend elevates demand for advanced mapping, ablation, and monitoring tools. It leads healthcare institutions to invest in modern electrophysiology labs to accommodate increasing patient volumes and complex cases.
For instance, hospitals in North America are expanding outpatient electrophysiology services to improve accessibility and reduce hospital stays.
Integration o Artificial Intelligence and Digital Health Solutions Enhancing Patient Care
The North America Electrophysiology Devices Market is experiencing significant integration of artificial intelligence, machine learning, and digital health platforms into electrophysiology workflows. AI-powered software supports arrhythmia detection, interpretation of complex signals, and risk stratification for patients. Remote monitoring and wearable ECG devices enable continuous, real-time patient assessment beyond hospital settings, driving earlier intervention and improved disease management. Hospitals adopt digital platforms to streamline patient data collection, boost workflow efficiency, and support personalized treatment planning. This digital transformation strengthens physician decision-making and overall care quality. It also encourages industry leaders to prioritize smart and connected device innovation.
For instance, wearable cardiac monitors are increasingly used in North America to track heart rhythms and support preventive healthcare strategies.
Surge in Research Collaborations and Strategic Alliances Fueling Innovation
A growing number of research collaborations and strategic partnerships between device manufacturers, hospitals, and academic institutions is accelerating technological progress in the North America Electrophysiology Devices Market. Companies enter joint ventures to share knowledge, pool resources, and co-develop advanced products. Hospitals participate in clinical trials to evaluate novel devices and procedures, providing crucial data to refine and validate innovations. This culture of collaboration fosters rapid translation of research breakthroughs into commercial solutions. It helps maintain the region’s leadership in global electrophysiology innovation and market competitiveness. These alliances expand access to emerging technologies for both patients and providers.
Expansion of Outpatient and Ambulatory Electrophysiology Services Broadening Access
A noticeable trend in the North America Electrophysiology Devices Market is the expansion of outpatient and ambulatory electrophysiology services. Healthcare systems recognize the need to increase patient access and reduce procedural costs by shifting certain diagnostics and treatments out of the hospital setting. Device manufacturers respond with portable, user-friendly systems tailored to ambulatory environments. Hospitals establish specialized electrophysiology clinics to manage growing demand for same-day procedures. This move supports healthcare cost containment and improves patient convenience. It encourages continuous innovation in device miniaturization, safety features, and procedural efficiency to meet evolving care delivery models.
Market Challenges Analysis
High Cost of Advanced Devices and Procedures Limiting Widespread Adoption
The North America Electrophysiology Devices Market faces significant challenges due to the high cost of advanced devices and procedures. Hospitals and clinics often require substantial capital investment to upgrade to the latest electrophysiology technology, creating financial strain for smaller and rural healthcare providers. Out-of-pocket expenses for patients without comprehensive insurance can hinder access to state-of-the-art treatments. Reimbursement gaps for certain innovative procedures may further restrict market reach, limiting adoption in underfunded regions. This cost barrier can slow the pace of technology diffusion across the broader healthcare system. It highlights the need for industry stakeholders to focus on affordability and reimbursement optimization.
For instance, many hospitals in North America struggle to secure funding for the latest electrophysiology equipment, limiting access to advanced cardiac care.
Workforce Shortages and Regulatory Complexities Affecting Market Growth
Shortages of specialized electrophysiologists and trained clinical staff present ongoing challenges for the North America Electrophysiology Devices Market. Hospitals often struggle to recruit and retain professionals with expertise in advanced electrophysiology procedures, which can delay patient care and limit procedural volumes. Complex regulatory requirements and lengthy approval timelines for new devices create hurdles for manufacturers seeking to introduce innovations quickly. Navigating evolving compliance standards demands significant time and resources from industry participants. It underscores the need for investment in professional training and streamlined regulatory processes to sustain long-term market growth. These workforce and regulatory constraints impact the region’s ability to meet rising demand and fully realize technology advancements.
Market Opportunities
Rising Demand for Remote Monitoring and Digital Health Creating Growth Pathways
The North America Electrophysiology Devices Market presents significant opportunities through the rising demand for remote monitoring and digital health solutions. Healthcare providers seek advanced wearable and implantable devices that enable continuous arrhythmia detection and data transmission outside traditional care settings. Integration of telemedicine and real-time patient monitoring expands access to electrophysiology expertise in underserved areas and supports proactive disease management. Device manufacturers can leverage these trends by developing connected solutions that improve patient engagement and outcomes. Partnerships with digital health companies offer new channels for technology integration and care delivery. This shift toward remote care opens doors for growth and innovation across the region.
Expansion into Emerging Therapeutic Areas and Personalized Medicine Advancing Market Potential
Emerging therapeutic areas and the movement toward personalized medicine provide the North America Electrophysiology Devices Market with new avenues for expansion. Advances in genomics, biomarker analysis, and AI-powered risk stratification are allowing for highly targeted treatment strategies and optimized device utilization. Hospitals and research institutions invest in clinical trials to explore innovative applications of electrophysiology technologies in complex cardiac and neurological conditions. It supports the adoption of tailored therapies that address unique patient profiles and comorbidities. Companies investing in research collaborations and niche product development can capture untapped market segments. This evolution toward personalized and precision-based interventions fuels long-term growth prospects.
Market Segmentation Analysis:
By Type:
Ablation catheters hold a significant share, driven by their effectiveness in treating various cardiac arrhythmias. Radiofrequency (RF) ablation remains the most widely adopted technology, valued for its clinical efficacy and established safety profile. Cryoablation is gaining ground due to its ability to minimize collateral tissue damage and its favorable outcomes in specific patient groups. Pulse field ablation is emerging as a next-generation modality, offering non-thermal ablation with precise tissue targeting and potential to address challenging cases. Diagnostic catheters are essential for mapping and localizing arrhythmogenic foci, supporting accurate diagnosis and tailored therapy. Laboratory devices, including 3D mapping systems and recording equipment, enhance procedural precision and workflow efficiency. Access devices, such as introducers and sheaths, facilitate safe and effective device delivery during interventions.
ByIndication:
The market divides into atrial fibrillation (AF) and non-atrial fibrillation segments. Atrial fibrillation represents the dominant indication, reflecting the rising incidence and growing awareness of this condition across North America. Advanced ablation and diagnostic technologies have improved AF management, expanding procedural volumes in both inpatient and outpatient settings. The non-atrial fibrillation segment, including ventricular tachycardia and supraventricular tachycardia, remains an important area, with innovation supporting broader adoption of electrophysiology interventions for complex arrhythmias.
By End-Use:
Inpatient facilities such as hospitals and academic medical centers account for the largest market share, supported by their capacity to handle complex electrophysiology procedures and advanced technology requirements. Outpatient facilities, including specialized electrophysiology clinics and ambulatory surgical centers, are experiencing rapid growth as demand for minimally invasive and same-day procedures increases. Other end-use settings, such as research institutions and mobile health units, contribute to market expansion by fostering innovation and broadening patient access to specialized care. The segmentation landscape underscores the dynamic and evolving nature of the North America Electrophysiology Devices Market, with ongoing advancements and shifting care delivery models shaping future growth.
Segments:
Based on Type:
Ablation Catheters
Radiofrequency (RF) Ablation
Cryoablation
Pulse Field Ablation
Diagnostic Catheters
Laboratory Devices
Access Devices
Based on Indication:
Atrial Fibrillation (AF)
Non-Atrial Fibrillation
Based on End-Use:
Inpatient Facilities
Outpatient Facilities
Others
Based on the Geography:
S.
Canada
Mexico
Regional Analysis
United States
The United States commands the largest share of the North America Electrophysiology Devices Market, accounting for approximately 82% of the regional market in 2024. Its dominant position stems from a combination of advanced healthcare infrastructure, strong research and development capabilities, and high adoption rates for innovative electrophysiology technologies. Major urban centers feature well-established cardiac centers, which continuously upgrade to state-of-the-art mapping, ablation, and diagnostic systems. Leading device manufacturers maintain significant operational presence and invest heavily in clinical trials, partnerships, and physician training programs. Favorable reimbursement policies and robust funding from both public and private sectors further stimulate market activity, allowing hospitals and outpatient facilities to offer cutting-edge arrhythmia diagnosis and treatment options. Patient awareness about electrophysiology procedures and the importance of early intervention remains high, which translates into increased procedural volumes and expanding device utilization. The U.S. regulatory environment, characterized by efficient approval processes for novel devices, enables the rapid introduction of next-generation technologies and drives market dynamism.
Canada
Canada represents about 13% of the North America Electrophysiology Devices Market, serving as the second-largest market in the region. Canadian healthcare providers demonstrate strong interest in adopting minimally invasive electrophysiology solutions, focusing on improving patient outcomes while managing healthcare costs. The country’s universal healthcare system encourages widespread access to advanced diagnostic and therapeutic procedures, with major hospitals and specialized cardiac centers leading the way in technological adoption. Canadian institutions participate in multinational research collaborations and clinical trials, supporting the introduction of innovative devices and best practices across the country. Regulatory authorities such as Health Canada provide clear guidelines and maintain close collaboration with industry stakeholders, ensuring patient safety and efficient market entry for new products. Despite a smaller population base than the U.S., Canada’s market growth benefits from an aging population and rising prevalence of arrhythmias, driving sustained demand for electrophysiology devices in both urban and regional healthcare settings.
Mexico
Mexico holds an estimated 5% market share within the North America Electrophysiology Devices Market, with growth prospects tied to expanding healthcare access and investments in modernizing medical infrastructure. The Mexican government and private sector partners are allocating resources to develop specialized cardiac care centers and upgrade equipment in major metropolitan hospitals. Efforts to improve awareness of arrhythmia risks and expand early diagnostic capabilities are supporting gradual market growth. While the adoption of advanced electrophysiology devices is currently lower than in the U.S. and Canada, rising prevalence of cardiovascular disease and increasing training initiatives for clinical staff are expected to accelerate future market development. Market access for international device manufacturers continues to improve through strategic partnerships and local distribution agreements, helping to introduce innovative solutions and build capacity for more complex procedures. Challenges remain in terms of reimbursement structures and equitable distribution of advanced technologies across rural and underserved areas, but ongoing policy reforms and public health campaigns are creating a favorable environment for market expansion.
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The competitive landscape of the North America Electrophysiology Devices Market is shaped by prominent players including Boston Scientific Corp., Medtronic, Abbott, Biosense Webster, Biotronik, General Electric Company, Siemens Healthcare AG, MicroPort Scientific Corporation, Koninklijke Philips N.V., Johnson & Johnson Services Inc., Atricure Inc., and Stereotaxis Inc. These companies consistently invest in research and development to introduce advanced technologies such as next-generation mapping systems, innovative ablation catheters, and integrated digital health solutions. Companies prioritize collaborations with healthcare institutions and academic centers to validate new products and support physician training, fostering strong clinical partnerships. The market sees frequent mergers, acquisitions, and joint ventures, enabling organizations to broaden their portfolios and enter new regional markets. Investment in artificial intelligence, remote monitoring, and data-driven solutions supports the shift toward minimally invasive and personalized care. Regulatory compliance and adherence to evolving standards remain priorities, ensuring rapid approval and adoption of next-generation devices. This dynamic environment encourages continuous improvement and positions the region as a global leader in electrophysiology technology and patient care.
Recent Developments
In August 2023, Biosense Webster received approval for various atrial fibrillation ablation products that can be utilized in a workflow without fluoroscopy during catheter ablation procedures.
In August 2023, Boston Scientific Corporation (US) launched the POLARx cryoablation system. This system is used to treat patients with paroxysmal atrial fibrillation.
In May 2023 Abbott Laboratories launched the Tactiflex ablation catheter which is sensor-enabled and it is used to treat the most common abnormal heart rhythm.
Market Concentration & Characteristics
The North America Electrophysiology Devices Market demonstrates a moderate to high level of market concentration, with several large, well-established manufacturers holding significant shares. It features a mature and innovation-driven environment, marked by rapid adoption of advanced technologies and a strong emphasis on research and development. The market’s competitive landscape is shaped by frequent product launches, collaborative research efforts, and strong relationships between industry players and healthcare providers. Demand centers on minimally invasive solutions, digital health integration, and high procedural accuracy, with healthcare systems seeking devices that improve outcomes and streamline workflows. Regulatory frameworks support the introduction of novel devices, fostering an environment that rewards safety, efficacy, and continuous improvement. The market’s characteristics include high entry barriers, robust investment in physician training, and a focus on comprehensive after-sales support, underscoring its commitment to quality and technological leadership across the region.
Report Coverage
The research report offers an in-depth analysis based on Type,Indication, End-Useand Geography. It details leading market players, providing an overview of their business, product offerings, investments, revenue streams, and key applications. Additionally, the report includes insights into the competitive environment, SWOT analysis, current market trends, as well as the primary drivers and constraints. Furthermore, it discusses various factors that have driven market expansion in recent years. The report also explores market dynamics, regulatory scenarios, and technological advancements that are shaping the industry. It assesses the impact of external factors and global economic changes on market growth. Lastly, it provides strategic recommendations for new entrants and established companies to navigate the complexities of the market.
Future Outlook
The North America electrophysiology devices market is expected to grow steadily due to the high incidence of atrial fibrillation and other arrhythmias.
Advancements in ablation technologies will drive the adoption of new-generation electrophysiology devices.
Strong presence of key market players will support continuous product innovation and clinical adoption.
Increasing preference for outpatient and minimally invasive procedures will boost the demand for electrophysiology systems.
Rising healthcare expenditure and improved insurance coverage will enhance patient access to advanced cardiac care.
The growing number of specialized electrophysiology centers will create new opportunities for device manufacturers.
Favorable regulatory support for new device approvals will accelerate market entry of novel technologies.
Ongoing training programs and physician education initiatives will improve procedural expertise across the region.
Strategic partnerships between hospitals and technology firms will contribute to integrated care delivery models.
Rising public awareness about cardiac health and early diagnosis will positively influence market penetration.
5.3 Segmental Wealth Flow – Type & Application Revenue
CHAPTER NO. 6 : TRADE & COMMERCE ANALYSIS
6.1.Import Analysis by Region
6.1.1. North America Electrophysiology Devices Market Import Revenue By Region
6.2.Export Analysis by Region
6.2.1. North America Electrophysiology Devices Market Export Revenue By Region
CHAPTER NO. 7 : COMPETITION ANALYSIS
7.1.Company Market Share Analysis
7.1.1. North America Electrophysiology Devices Market: Company Market Share
7.2. North America Electrophysiology Devices Market Company Revenue Market Share
7.3.Strategic Developments
7.3.1.Acquisitions & Mergers
7.3.2. New Product Launch
7.3.3. Regional Expansion
7.4. Competitive Dashboard
7.5. Company Assessment Metrics, 2024
CHAPTER NO. 8 : NORTH AMERICA ELECTROPHYSIOLOGY DEVICES MARKET – BY TYPE SEGMENT ANALYSIS
8.1.North America Electrophysiology Devices Market Overview by Type Segment
8.1.1. North America Electrophysiology Devices Market Revenue Share By Type
8.2. Ablation Catheters
8.3.1 Radiofrequency (RF) Ablation
8.3.2 Cryoablation
8.3.4 Pulse Field Ablation
8.4.4 Diagnostic Catheters
8.3 Laboratory Devices
8.4 Access Devices
CHAPTER NO. 9 : NORTH AMERICA ELECTROPHYSIOLOGY DEVICES MARKET – BY INDICATION SEGMENT ANALYSIS
9.1. North America Electrophysiology Devices Market Overview by Indication Segment
9.1.1. North America Electrophysiology Devices Market Revenue Share By Indication
9.2. Atrial Fibrillation (AF)
9.3.Non-Atrial Fibrillation
CHAPTER NO. 10 : NORTH AMERICA ELECTROPHYSIOLOGY DEVICES MARKET – BY END-USE SEGMENT ANALYSIS
10.1.North America Electrophysiology Devices Market Overview by End-use Segment
10.1.1. North America Electrophysiology Devices Market Revenue Share By End-use
10.2.Inpatient Facilities
10.3. Outpatient Facilities
10.4. Others
CHAPTER NO. 11 : NORTH AMERICA ELECTROPHYSIOLOGY DEVICES MARKET – BY COUNTRY SEGMENT ANALYSIS
11.1.North America Electrophysiology Devices Market Overview by Country Segment
11.1.1. North America Electrophysiology Devices Market Revenue Share By Country
11.2. U.S.
11.3. Canada
11.4. Mexico
CHAPTER NO. 12 : COMPANY PROFILES
12.1. Boston Scientific Corp.
12.1.1.Company Overview
12.1.2.Product Portfolio
12.1.3.Financial Overview
12.1.4.Recent Developments
12.1.5.Growth Strategy
12.1.6.SWOT Analysis
12.2. Medtronic
12.3.Abbott
12.4.Biosense Webster
12.5.Biotronik
12.6.General Electric Company
12.7.Siemens Healthcare AG
12.8. MicroPort Scientific Corporation
12.9. Koninklijke Philips N.V.
12.10 Jhonson & Jhonson Services Inc.
12.12 Atricure Inc.
12.12 Stereoaxis Inc.
Frequently Asked Questions
What is the current size of the North America Electrophysiology Devices Market?
The North America Electrophysiology Devices Market is valued at USD 6,082.68 million in 2024.
What factors are driving the growth of the North America Electrophysiology Devices Market?
Key drivers include rising cardiovascular disease prevalence, a growing geriatric population, and rapid adoption of advanced diagnostic and ablation technologies.
What are the key segments within the North America Electrophysiology Devices Market?
The market is segmented by type (ablation catheters, diagnostic catheters, laboratory devices, access devices), indication (atrial fibrillation, non-atrial fibrillation), and end-use (inpatient, outpatient, others).
Who are the major players in the North America Electrophysiology Devices Market?
Major players include Boston Scientific Corp., Medtronic, Abbott, Biosense Webster, and others.
About Author
Shweta Bisht
Healthcare & Biotech Analyst
Shweta is a healthcare and biotech researcher with strong analytical skills in chemical and agri domains.
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