FDA Approves Flyrcado Radioactive Diagnostic for Enhanced Diagnosis of Coronary Artery Disease
GE HealthCare announced the U.S. Food and Drug Administration (FDA) granted approval of Flyrcado (flurpiridaz F-18) injection, a first-of-its-kind positron emission tomography myocardial perfusion imaging (PET MPI) agent, for the detection of coronary artery disease (CAD).
- Indicated for patients with known or suspected CAD, Flyrcado delivers higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT) MPI, the predominant procedure used in nuclear cardiology today.
- Flyrcado, which can be manufactured in an offsite pharmacy and delivered as a ready-to-use unit dose, has the potential to expand clinician and patient access to PET MPI, including improving diagnostic accuracy in difficult-to-image patients such as those with a high body mass index (BMI) and women.
Source: GE HealthCare
