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”.

More at: https://dengyuemed.com/news/flyrcado-a-breakthrough-in-cardiac-pet-imaging/