GE HealthCare advances cardiac PET diagnostics with Flyrcado launch
GE HealthCare has positioned itself at the forefront of precision cardiac diagnostics with the commercial launch of Flyrcado™ (flurpiridaz F 18) injection, marking the first new PET myocardial perfusion tracer to enter clinical practice in nearly two decades. The advanced molecular imaging agent represents a significant technological leap in coronary artery disease detection, offering clinicians enhanced diagnostic confidence compared to conventional SPECT imaging protocols.
Revolutionary imaging technology addresses growing cardiovascular burden
The timing of Flyrcado’s market introduction coincides with escalating global cardiovascular disease rates, creating urgent demand for advanced diagnostic capabilities. GE HealthCare’s molecular imaging portfolio, encompassing both PET/CT and SPECT/CT platforms alongside targeted radiopharmaceuticals, enables precise assessment of myocardial perfusion and ischemia whilst evaluating infiltrative cardiomyopathies through detailed biological process visualisation.
“Flyrcado represents one of the most significant advancements in nuclear cardiology in decades,” shares Dr Marcelo Fernando DiCarli, Chief of Nuclear Medicine and Molecular Imaging at Brigham and Women’s Hospital. “For the first time in nearly 20 years, we have a new PET myocardial perfusion tracer that brings the latest imaging technology within reach for patients across the U.S. The image quality is exceptional, and its use has the potential to reduce unnecessary invasive procedures by improving diagnostic confidence.”
Comprehensive coverage expansion enhances patient access
The F-18 unit dose PET myocardial perfusion imaging agent has secured substantial reimbursement coverage following its CMS pass-through status approval, effective April 1. All seven Medicare Administrative Contractors now provide coverage at invoice price or better, whilst over 50% of commercially insured beneficiaries benefit from updated national and regional cardiac PET policies incorporating Flyrcado coverage.
“With coverage now in place for all traditional Medicare beneficiaries, along with updated PET coverage policies in place for more than half of the nation’s commercially insured beneficiaries, millions of Americans will have greater access to this innovative technology,” said Eric Ruedinger, Vice President and General Manager of GE HealthCare’s Pharmaceutical Diagnostics division for the U.S. and Canada.
Technical specifications and clinical integration
Flyrcado demonstrates compatibility across multiple PET/CT systems, including GE HealthCare’s Omni Legend platform, facilitating seamless integration into existing imaging workflows. The tracer enables the first practical combination of exercise stress testing with cardiac PET imaging for coronary artery disease evaluation, providing highly effective ischemia assessment protocols.
The Omni Legend system, representing GE HealthCare’s fastest-selling PET/CT platform, accommodates diverse tracers including fast-decay and emerging compounds whilst delivering up to 40% dose reduction or 32% scan time reduction compared to previous generation systems.
Regulatory status and safety profile
Flyrcado carries FDA approval for PET myocardial perfusion imaging under rest or stress conditions in adult patients with known or suspected coronary artery disease. The safety profile includes standard contraindications for stress testing environments, with most common adverse reactions (≥2% incidence) including dyspnea, headache, angina pectoris, chest pain, and fatigue.
Special populations require careful consideration, with pregnancy and lactation protocols established for safe administration. The product contains ethanol (maximum 337 mg anhydrous ethanol daily), necessitating appropriate patient counselling.
Expanding diagnostic ecosystem
Beyond Flyrcado, GE HealthCare’s comprehensive cardiac imaging portfolio includes StarGuide and Aurora SPECT/CT systems, designed for optimal gamma ray detection with exceptional image quality and scan efficiency. Additional MIM Software solutions enable multi-modality viewing and cardiac image fusion, supporting integrated diagnostic workflows.
The company’s commitment to precision cardiac care spans from early detection through intervention monitoring, supporting healthcare professionals across diverse clinical settings from major medical centres to community clinics.
- For more information, visit: https://www.gehealthcare.com/products/molecular-imaging
