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ACC 2025: GE HealthCare announces the U.S. launch of pivotal innovations that will help transform the cardiology care pathway
The much-anticipated Flyrcado™ (flurpiridaz F 18) injection, a first-of-its-kind unit dose positron emission tomography myocardial perfusion imaging agent
About this update from Ge Healthcare Technologies Inc.
[{"type":"text","content":"\n\nThe much-anticipated Flyrcado™ (flurpiridaz F 18) injection, a first-of-its-kind unit dose positron emission tomography myocardial perfusion imaging agent for the detection of coronary artery disease, is now available in select U.S. markets and has been granted traditional pass-through payment status by the U.S. Centers for Medicare and Medicaid.\n\n\n CHICAGO--(BUSINESS WIRE)--\nGE HealthCare (Nasdaq: GEHC) today announced the U.S. launch of Flyrcado™ (flurpiridaz F 18) injection at the 2025 American College of Cardiology (ACC) Annual Scientific Session & Expo, taking place March 29-31 in Chicago. Additionally, the company will showcase new AI-powered innovations, reflecting its strategy to leverage AI to help increase efficiency and enable seamless integration of data across the cardiology care pathway. GE HealthCare has been investing in AI for years and has topped the FDA list of AI-enabled device authorizations for three years in a row with 85 authorizations.i\n\n“The future of healthcare lies in the integration of advanced technologies with human expertise, allowing for a more holistic, data-driven and efficient cardiology care pathway,” said Eigil Samset, general manager of Cardiology Solutions at GE HealthCare. “Cardiovascular diseases are the leading cause of death globally, so it is critical that we continue our commitment to innovations in this space – our newest solutions showcased at ACC will help transform and optimize the diagnostic workflow.”\n\nFlyrcado U.S. launch and U.S. Centers for Medicare and Medicaid (CMS) pass-through status\n\nIn 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)ii myocardial perfusion imaging (MPI), the predominant procedure used in nuclear cardiology today.\n\nAround six million MPI procedures are undertaken each year in the U.S.iii 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 CADiv 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 breastsv, over SPECT MPI. With i...