In a landmark advancement for nuclear cardiology, GE HealthCare has launched Flyrcado™ (flurpiridaz F 18), the first FDA-approved unit-dose positron emission tomography (PET) myocardial perfusion imaging (MPI) agent for detecting coronary artery disease (CAD).

Approved in September 2024 and commercially available in select U.S. markets since early 2025, Flyrcado promises higher diagnostic accuracy, broader accessibility, and enhanced clinical flexibility compared to traditional SPECT MPI.

This innovation marks the first new cardiac perfusion tracer in nearly 30 years, addressing long-standing limitations in cardiac imaging.

With its 109-minute half-life—ten times longer than conventional PET tracers—Flyrcado enables centralized production and nationwide distribution, eliminating the need for on-site cyclotrons and expanding access to community hospitals and smaller healthcare systems.

Superior Diagnostic Performance

Flyrcado’s clinical advantages are backed by robust data:

Higher Sensitivity & Specificity: In the AURORA Phase III trial, Flyrcado demonstrated superior diagnostic efficacy compared to SPECT MPI and invasive coronary angiography, particularly in high-BMI patients and women with dense breast tissue, who often yield suboptimal SPECT results.

Enhanced Image Resolution: PET’s 2-3 mm spatial resolution (vs. SPECT’s 10-15 mm) allows for earlier detection of ischemia and microvascular disease.

First PET Tracer for Exercise Stress Testing: Unlike short-lived PET agents, Flyrcado’s 110-minute half-life permits exercise stress protocols, providing physiologically relevant data under real-world cardiac load conditions.

Dr. Jamshid Maddahi (UCLA), lead investigator of the AURORA trial, hailed Flyrcado as a "paradigm shift," noting its potential to "surpass SPECT in diagnostic confidence and clinical utility".

Expanding Access And Reimbursement

Flyrcado’s unit-dose formulation overcomes a major barrier to PET adoption—logistical constraints tied to tracer production. Houston Methodist Hospital, the first U.S. site to administer Flyrcado (February 2025), highlights its role in democratizing advanced cardiac diagnostics.

Key milestones in accessibility:

CMS Pass-Through Status (Effective April 1, 2025): Ensures separate reimbursement for the tracer and PET-CT scans under Medicare, using HCPCS code A9611.

Projected Nationwide Coverage: GE HealthCare anticipates near-universal U.S. availability by late 2025, with manufacturing partners already scaling production.

Dr. Mouaz Al-Mallah (Houston Methodist) emphasized Flyrcado’s impact: "This technology allows underserved hospitals to offer state-of-the-art cardiac imaging without costly infrastructure".

Flyrcado Safety And Clinical Guidelines

Flyrcado’s safety profile aligns with standard PET MPI agents, with no absolute contraindications.

Key considerations:

Adverse Reactions: Most common (≥2% incidence) include dyspnea, headache, angina, chest pain, and arrhythmia—primarily linked to stress testing rather than the tracer itself.

Radiation Exposure: The effective dose (~6.4 mSv) is lower than SPECT MPI. Patients are advised to hydrate and void frequently to minimize exposure.

Special Populations:

• Pregnancy: Ethanol content (337 mg/dose) and radiation risks warrant cautious use.
• Lactation: Discontinue breastfeeding for ≥8 hours post-dose.

Future Implications

Flyrcado’s launch coincides with GE HealthCare’s AI-driven cardiology innovations unveiled at ACC 2025, including:

• CASE™ AI Stress Testing: Integrates ECG and perfusion data for faster diagnosis.
• CardIQ Suite: Automates calcium scoring and CCTA analysis.

Industry experts predict Flyrcado will accelerate PET adoption, potentially replacing 20-30% of SPECT MPI procedures within 5 years712. With 6 million MPI tests performed annually in the U.S., this shift could reduce misdiagnoses and unnecessary invasive procedures.

Conclusion

Flyrcado represents a transformative leap in cardiac imaging, combining precision, accessibility, and clinical versatility. As Dr. Al-Mallah noted, "This isn’t just an advancement in technology—it’s a crucial expansion of care." 

With CMS reimbursement secured and broad rollout underway, Flyrcado is poised to redefine CAD diagnostics, offering earlier interventions and improved outcomes for millions of patients.

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