The FDA approved GE HealthCare's diagnostic drug for use in the detection of coronary artery disease, the company announced.

Flyrcado, which is a radioactive diagnostic drug for positron emission tomography (PET) myocardial perfusion imaging (MPI), will be available in some U.S. markets in early 2025 before being expanded.

PET-MPI is a non-invasive imaging test that uses radioactive tracers to asses blood flow to the muscle of the heart. The 3D images of the tracer's distribution can then be produced.

Flyrcado, which can be manufactured in an offsite pharmacy and delivered as a ready-to-use unit dose, may expand access to PET-MPI by improving diagnostic accuracy in difficult-to-image patients such as those with a high body mass index and women.

Clinicians have underscored Flyrcado's distinct clinical benefits such as higher-quality imaging, greater defect resolution, and improved workflow.

Use of Flyrcado helped accurately classify 74% to 89% of participant scans in a study.

GE HealthCare said Flyrcado delivers higher diagnostic efficacy in patients with known or suspected CAD, compared to SPECT MPI which is the predominant procedure currently being used.

Flyrcado decays 10 times slower than currently approved cardiac PET radiotracers, GE HealthCare said, which can help combine exercise stress testing with imaging.