Sept 27 (Reuters) - The U.S. Food and Drug

Administration approved GE HealthCare's ( GEHC ) diagnostic drug

for use in detection of coronary artery disease, the company

said on Friday.

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 which uses a type of

nuclear medicine called radioactive tracers to asses how well

blood flows to the muscle of the heart. The 3D images of the

tracer's distribution can then be produced.

The company said Flyrcado, which can be manufactured in an

offsite pharmacy and delivered as a ready-to-use unit dose, has

the potential to expand access to PET-MPI, including improving

diagnostic accuracy in difficult-to-image patients such as those

with a high body mass index and women.

Doctors have underscored Flyrcado's distinct clinical

benefits such as higher-quality imaging, greater defect

resolution and improved workflow, brokerage Stifel said in a

note ahead of the approval.

Use of Flyrcado helped accurately classify 74% to 89% of

participant scans in a study.

GE HealthCare ( GEHC ) 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.

CAD is the narrowing or blockage of the coronary arteries,

which supply oxygen-rich blood to the heart. It impacts over 18

million adults in the U.S., and is the leading cause of death in

the country, according to the FDA.

Flyrcado decays ten times slower than currently approved

cardiac PET radiotracers, GE HealthCare ( GEHC ) said, which can help

combine exercise stress testing with imaging.

The company also has similar products for detection of

breast cancer and Alzheimer's disease.

Stifel analysts estimate approval of Flyrcado could add

about 0.3% to 0.6% of sales growth for the company in the medium

to long term.