GE HealthCare’s Flyrcado (flurpiridaz F 18) PET Radiotracer Receives FDA Approval for Enhanced Detection of Coronary Artery Disease

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved GE HealthCare's Flyrcado (flurpiridaz F 18) PET radiotracer for the detection of coronary artery disease (CAD).

Diagnostic Efficacy:
Flyrcado offers higher diagnostic efficacy compared to SPECT MPI, the current standard in nuclear cardiology, particularly for challenging patients such as those with high BMI and women.

Half-Life:
The radiotracer has a 109-minute half-life, allowing for off-site production and wider distribution, which can expand access to PET myocardial perfusion imaging (MPI).

Availability:
Flyrcado is expected to be available in select U.S. markets by early 2025, with plans for broader availability thereafter.

Clinical Advantages:
The new radiotracer enables the combination of exercise stress testing with cardiac PET imaging and offers improved imaging for difficult-to-image patients, potentially revolutionizing the field of nuclear cardiology.

Market Impact:
Analysts predict that Flyrcado could contribute significantly to GE HealthCare's sales growth in the medium to long term, with quick uptake expected among U.S. cardiac PET centers.