CAD is the most common form of heart disease and remains the leading cause of death for men and women in the US, with 371,506 deaths reported in 2022[1]. During the multicenter international AURORA Phase III trial, flurpiridaz F 18 was compared with both invasive coronary angiography as a standard of truth to determine diagnostic efficacy in detecting CAD, as well as with SPECT MPI. Around six million MPI procedures are undertaken each year in the US[2] to show blood flow through the heart muscle and evaluate the presence, extent and degree of myocardial ischemia or infarction. Flyrcado brings the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD, enabling the most robust protocol for evaluating ischemia in patients.
GE HealthCare will mark the commercial launch of Flyrcado at the annual American College of Cardiology congress in Chicago from March 29-31, 2025, and expects to receive pass-through status from the US Centers for Medicaid and Medicare (CMS) shortly thereafter, enabling separate reimbursement for Flyrcado in the hospital outpatient setting. This would facilitate patient access and enhance diagnostic capabilities for clinicians. GE HealthCare is also collaborating with commercial payers to ensure Flyrcado is recognized for its value and potential to improve patient outcomes and thus becomes a covered benefit for in-network beneficiaries.

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As a leading global medical technology and pharmaceutical diagnostics innovator, GE HealthCare provides both molecular imaging equipment and radiopharmaceuticals used across cardiology, neurology and oncology. The PDx segment is a global leader in imaging agents which supported over 130 million patient procedures in 2024, equivalent to four patient procedures every second.
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