GE Healthcare Launches Innovative Imaging Agent for Heart Disease Detection

2025-03-28 transformation

United States, Friday, 28 March 2025.
GE Healthcare introduced Flyrcado, a PET imaging agent, in select U.S. markets to improve coronary artery disease diagnostics, with CMS coverage starting April 2025.

Revolutionary Advancement in Cardiac Imaging

GE Healthcare’s Flyrcado marks a significant breakthrough in cardiac diagnostics, offering enhanced detection capabilities for the approximately 6 million annual myocardial perfusion imaging procedures conducted in the United States [1]. The FDA-approved PET imaging agent delivers superior diagnostic efficacy compared to traditional single-photon emission computed tomography (SPECT) imaging [2]. With its notable 109-minute half-life, Flyrcado represents the first practical opportunity to combine exercise stress testing with cardiac PET imaging for coronary artery disease assessment [3].

Medicare Coverage Enhances Accessibility

The strategic launch timing aligns with the Centers for Medicare and Medicaid Services (CMS) granting pass-through status, effective April 1, 2025 [4]. This crucial development enables separate reimbursement for both the radiopharmaceutical and PET-CT scanning procedures in hospital outpatient settings [5]. The designation includes a specific Healthcare Common Procedure Coding System (HCPCS) billing code, ensuring coverage for traditional Medicare beneficiaries [6].

Clinical Implementation and Expert Perspectives

The technology shows particular promise for challenging diagnostic cases, including patients with high body mass index and women with dense breast tissue [7]. Dr. Jamshid Maddahi of UCLA School of Medicine, a principal investigator in the Flyrcado clinical trials, notes that this development could significantly expand access to cardiac PET scanning, which currently represents only a small fraction of annual PET procedures [8]. The medical community will gain firsthand insights during the American College of Cardiology’s annual scientific session in Chicago, where clinicians from early adopter sites will share their experiences through various educational sessions [9].

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imaging agent coronary disease