GE HealthCare plans to launch its Flyrcado (flurpiridaz F-18) injection in the U.S. at the 2025 American College of Cardiology (ACC) Annual Scientific Session & Expo to be held March 29 to 31 in Chicago, IL.
The company received approval from the U.S. Food and Drug Administration (FDA) for the injection in 2024. Flyrcado is a unit-dose PET myocardial perfusion imaging (MPI) agent intended for patients with known or suspected coronary artery disease. Flyrcado delivers higher diagnostic efficacy compared with standard SPECT MPI, GE said. It added that the injection can be ordered as a ready-to-use unit dose due to its 109-minute half-life.
GE HealthCare's launch coincides with the receipt of pass-through status by the Centers for Medicare & Medicaid Services (CMS), effective April 1st. The company also secured a drug-specific Healthcare Common Procedure Coding System billing code and coverage for traditional Medicare beneficiaries who may be recommended for the injection. Pass-through payment status will allow the CMS to provide separate payments for the radiopharmaceutical and the PET-CT scan when performed with Flyrcado in the hospital outpatient setting.
Flyrcado will be unveiled at the ACC conference on March 29. Clinicians from several clinical trials and early adopter sites will participate in learning lab sessions, innovation stage talks, and "Meet the Expert" breakout sessions to share their experiences with using Flyrcado.
