GE HealthCare announces FDA approval of Flyrcado injection PET radiotracer

GE HealthCare announced that the U.S. Food and Drug Administration has granted approval of Flyrcado injection, a first of its kind positron emission tomography myocardial perfusion imaging agent, for the detection of coronary artery disease. Indicated for patients with known or suspected CAD, Flyrcado delivers higher diagnostic efficacy compared to single-photon emission computed tomography 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 and women. Dr. Jamshid Maddahi, MD, FACC, MASNC, principal investigator of the Flyrcado clinical trials, clinical professor of medicine (cardiology) and molecular and medical pharmacology (nuclear medicine) at UCLA School of Medicine and director of the Biomedical Imaging Institute, said, “Flyrcado is the most exciting development in the field of nuclear cardiology over the past few decades. Although PET MPI as a modality enables high diagnostic accuracy as compared to SPECT MPI2, only a minority of annual PET scans in the US are PET MPI because of limited access to the currently available PET tracers-which may be addressed with the introduction of Flyrcado. I am excited for this new radiotracer and its potential impact, as a game changer, for diagnosing the disease with the highest mortality rate in the world.”