CHICAGO--(BUSINESS WIRE)--GE 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

“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.”

Flyrcado U.S. launch and U.S. Centers for Medicare and Medicaid (CMS) pass-through status

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)ii myocardial perfusion imaging (MPI), the predominant procedure used in nuclear cardiology today.

Around 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 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.

Today, GE HealthCare announced the commercial launch of Flyrcado, a first-of-its-kind unit dose positron emission tomography myocardial perfusion imaging (PET MPI) agent, now available in select U.S. markets. This launch coincides with the receipt of pass-through status by the CMS, effective April 1st, 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.

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