GE HealthCare announced that the FDA has approved Flyrcado™ (flurpiridaz F 18) injection, a groundbreaking PET myocardial perfusion imaging (MPI) agent, for detecting coronary artery disease (CAD). Flyrcado offers higher diagnostic accuracy than the widely used SPECT MPI and is designed to improve access to PET MPI, especially for hard-to-image patients like those with high BMI. With a 109-minute half-life, Flyrcado eliminates the need for on-site tracer production, enabling broader distribution to hospitals and imaging centers. It also allows for exercise stress testing with PET imaging, enhancing the evaluation of ischemia in CAD patients.
Dr. Jamshid Maddahi, the principal investigator for Flyrcado’s clinical trials, highlighted its potential to transform nuclear cardiology by providing better access to PET MPI, which currently accounts for only a small fraction of annual PET scans in the U.S. Dr. Mouaz Al-Mallah emphasized Flyrcado’s convenience and its potential to expand cardiac PET imaging, making it more accessible and impactful for patients.
Kevin O’Neill, CEO of GE HealthCare’s Pharmaceutical Diagnostics segment, stated that Flyrcado, as the first FDA-approved F 18 PET MPI radiotracer for CAD, underscores the company’s commitment to innovation in molecular imaging. Flyrcado joins GE HealthCare’s portfolio of FDA-approved PET imaging agents, which also includes Cerianna™ for breast cancer and Vizamyl™ for Alzheimer’s disease.
Flyrcado will be available in select U.S. markets in early 2025, with wider availability to follow. GE HealthCare, a global leader in medical technology and diagnostics, acquired the exclusive global commercialization rights for flurpiridaz F 18 from Lantheus in 2017, and the two companies will collaborate on its commercialization.
