March 27, 2025 — GE HealthCare is announcing the U.S. launch of Flyrcado (flurpiridaz F 18) injection at the 2025 American College of Cardiology (ACC) Annual Scientific Session & Expo in Chicago.
Flyrcado is a unit dose positron emission tomography myocardial perfusion imaging (PET MPI) agent.
In 2024, the FDA approved Flyrcado for patients with known or suspected coronary artery disease (CAD), delivering higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT)i myocardial perfusion imaging (MPI), the predominant procedure used in nuclear cardiology today.
Around 6 million MPI procedures are undertaken each year in the U.S.ii to show blood flow through the heart muscle and evaluate the presence, extent and degree of myocardial ischemia or infarction. PET is the most effective form of MPI for detecting CADiii and is recommended for a wide range of patients, including those considered more challenging to diagnose, such as individuals with a BMI greater than 30 or women, especially those with dense breastsiv, over SPECT MPI. With its 109-minute half-life, Flyrcado can be ordered as a ready-to-use unit dose and offers clinicians the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD, providing a highly effective protocol for evaluating ischemia in patients.
Flyrcado is now available in select U.S. markets. This launch coincides with the receipt of pass-through status by the CMS, effective April 1, securing a drug-specific Healthcare Common Procedure Coding System (HCPCS) billing code and coverage for traditional Medicare beneficiaries. Pass-through payment status — typically granted to facilitate patient access to innovative devices and drugs—will enable CMS to provide separate payments for the radiopharmaceutical and the PET-CT scan, when performed with Flyrcado in the hospital outpatient setting.
“The launch of Flyrcado represents a significant advancement in cardiac care, providing a new, highly effective diagnostic tool for those with known or suspected coronary artery disease,” said Eric Ruedinger, vice president and general manager of GE HealthCare’s Pharmaceutical Diagnostics segment for the U.S. and Canada. “With the grant of pass-through status by CMS, and the official commercial launch of Flyrcado, we are pleased that millions of patients throughout the U.S. will have access to this innovative technology, which will help improve diagnostic accuracy and may lead to better patient outcomes."
Flyrcado will be unveiled at ACC on March 29, and throughout the conference, clinicians from several clinical trial and early adopter sites will participate in learning lab sessions, innovation stage talks, and 'Meet the Expert' breakout sessions to share their experiences and insights on using Flyrcado.
Click here to learn more about Flyrcado.
i Maddahi, J, Agostini, D, Bateman, T. et al. Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients With Suspected Coronary Artery Disease. JACC. 2023 Oct, 82 (16) 1598–1610. https://doi.org/10.1016/j.jacc.2023.08.016
ii Miller, R. J. H., Bednarski, B. P., Pieszko, K., Kwiecinski, J., Williams, M. C., Shanbhag, A., Liang, J. X., Huang, C., Sharir, T., Hauser, M. T., Dorbala, S., Di Carli, M. F., Fish, M. B., Ruddy, T. D., Bateman, T. M., Einstein, A. J., Kaufmann, P. A., Miller, E. J., Sinusas, A. J., Acampa, W., Han, D., Dey, D., Berman, D. S., & Slomka, P. J. (2024). Clinical phenotypes among patients with normal cardiac perfusion using unsupervised learning: A retrospective observational study. EBioMedicine, 99, 104930. https://doi.org/10.1016/j.ebiom.2023.104930
iii1. Driessen RS, Raijmakers PG, Stuijfzand WJ, Knaapen P. Myocardial perfusion imaging with PET. Int J Cardiovasc Imaging. 2017;33(7):1021-1031.
iv Bateman TM, Dilsizian V, Beanlands RS, DePuey EG, Heller GV, Wolinsky DA. American Society of Nuclear Cardiology and Society of Nuclear Medicine and Molecular Imaging Joint Position Statement on the Clinical Indications for Myocardial Perfusion PET. J Nucl Med . 2016;57(10):1654-1656.
July 31, 2024 
