Cardiovascular Medical Device and Diagnostics Development
Broad Cardiovascular Experience
Specialized medical device and diagnostics experience supporting cardiovascular programs from early feasibility and first-in-human studies through pivotal trials and post-market activities
Global Development Capabilities
Global development experience and regulatory knowledge supporting multinational studies, including FDA, EU MDR/IVDR and UK requirements
Operational Delivery for Complex Studies
Coordinated clinical operations, medical monitoring, biostatistics, data management and quality focused processes supporting consistent execution of complex cardiovascular studies
Advancing Cardiovascular Device and Diagnostics Programs Across the Development Lifecycle
Fortrea supports sponsors in advancing cardiovascular medical devices, in vitro diagnostics (IVDs) and digital health technologies throughout development, from early feasibility studies to post-market evidence generation, helping bring innovative solutions to patients worldwide.
Our teams have experience supporting a broad range of vascular technologies, including peripheral and coronary interventions, drug-coated technologies, stents, thrombectomy devices, embolization products, vascular access solutions, and structural heart interventions.
Over a 5-year period within cardiovascular specifically:
This breadth supports delivery across diverse geographies and patient populations.
Why Fortrea for Cardiovascular Device and Diagnostics Development?
Explore How Fortrea Can Support Your Cardiovascular Development Program
Beyond traditional clinical trial execution, Fortrea's Medical Device & Diagnostics team supports sponsors with development strategy, regulatory pathway planning, risk-based study design, evidence generation, clinical evaluation support, and post-market evidence programs. Our experience spans Class II and Class III cardiovascular technologies, implantable devices, diagnostics, connected health solutions, and software-enabled medical technologies, helping sponsors efficiently progress from concept to commercialization.
Supporting a Range of Cardiovascular Technologies
Fortrea supports development programs across multiple cardiovascular therapy areas, including:
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Structural Heart
Fortrea supports structural heart programs that use transcatheter and surgical approaches to treat valve disease and other structural conditions. Our experience covers aortic, mitral and tricuspid valve repair and replacement, surgical heart valves, annuloplasty systems and left atrial appendage closure devices. We support the full lifecycle, from early feasibility and first-in-human studies through pivotal, post-approval and registry studies. That includes selecting experienced implanting centres and coordinating imaging and long-term follow-up.
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Coronary and Peripheral Vascular Disease
Our teams support interventions that restore blood flow and treat vascular disorders. Indications include coronary artery disease, acute coronary syndrome, peripheral artery disease, and abdominal and thoracic aortic aneurysms. Device types include coronary and peripheral drug-eluting stents, drug-coated balloons, endovascular and thoracic aortic stent grafts, venous stents and thrombectomy systems. We also support studies that need long-term follow-up across multiple countries.
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Cardiac Rhythm Management
Fortrea supports the clinical development of pacing, defibrillation, electrophysiology and rhythm-monitoring technologies. Our experience includes permanent and leadless pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronisation therapy (CRT) devices, ablation catheters and implantable loop recorders. Atrial fibrillation is one of the top indications in our cardiovascular device portfolio.
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Cardiovascular Diagnostics
We support evidence generation for cardiovascular diagnostic devices, IVDs and biomarker-based technologies, as well as imaging solutions. Our support spans clinical performance studies and regulatory pathways under FDA, EU MDR/IVDR and UK requirements. Integrated data management, biostatistics and quality oversight help produce robust evidence for regulatory, reimbursement and commercial decisions.
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Digital Cardiovascular Health
Fortrea has experience with connected technologies, wearable devices, software-enabled medical technologies and remote patient monitoring, including heart failure monitoring technologies. We help sponsors design studies that capture continuous, real-world data and handle the data integrity and usability needs specific to digital health.
Our Medical Device & Diagnostics team has successfully supported sponsors developing:
- Transcatheter aortic, mitral and tricuspid valve technologies
- Coronary, peripheral vascular and venous intervention devices
- Leadless pacemakers, ICDs, CRT systems and electrophysiology platforms
- Heart failure monitoring and mechanical circulatory support technologies
- Cardiovascular diagnostic and biomarker-based testing solutions
- Connected health, wearable monitoring and AI-enabled cardiovascular technologies
- Post-market registries and long-term follow-up programs supporting global regulatory and commercial objectives
From first-in-human investigations to global pivotal studies and post-market evidence programs, Fortrea provides integrated clinical, regulatory, operational and scientific experience to help sponsors advance innovative cardiovascular technologies from concept to commercialization
Frequently Asked Questions (FAQs)
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What types of cardiovascular devices and diagnostics does Fortrea support?
Fortrea supports a broad range of cardiovascular technologies, including structural heart, interventional cardiology, cardiac rhythm management, vascular intervention, heart failure and cardiovascular diagnostics.
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Can Fortrea support global cardiovascular studies?
Yes. Fortrea conducts cardiovascular studies across established and emerging markets, supporting site selection, study execution and patient recruitment worldwide.
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Does Fortrea support early feasibility and first-in-human studies?
Yes. Fortrea supports cardiovascular development from early feasibility and first-in-human studies through pivotal trials, post-approval studies, registries and post-market research.
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What services does Fortrea provide for cardiovascular studies?
Fortrea offers clinical operations, project management, medical monitoring, regulatory support, data management, biostatistics, safety, patient recruitment and quality oversight throughout the study lifecycle.
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Can Fortrea support post-market cardiovascular studies?
Yes. Fortrea supports post-market clinical follow-up (PMCF), post-market performance follow-up (PMPF), registries, long-term follow-up studies, performance evaluation studies, and real-world evidence (RWE) programmes.
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Why work with a CRO for cardiovascular device studies?
A CRO can provide global study delivery, regulatory support and operational capabilities across feasibility, pivotal and post-market studies.
Ready to advance your cardiovascular device or diagnostic program?
Connect with our team to discuss your development goals and explore solutions that support your clinical, regulatory, and commercial objectives.