US FDA approves GE HealthCare diagnostic drug for heart disease By Reuters
(Reuters) – The U.S. Food and Drug Administration has approved GE HealthCare’s (NASDAQ: ) diagnostic drug for use in the diagnosis of coronary artery disease, the company said on Friday.
Flyrcado, a positron emission tomography (PET) myocardial perfusion imaging (MPI) drug, will be available in some US markets in early 2025 before being expanded.
PET-MPI is a non-invasive imaging test that uses a type of nuclear medicine called radioactive tracers to check how well blood is flowing through the heart muscle. 3D images of tracer distribution can then be generated.
The company said Flyrcado, which can be made in an off-site pharmacy and delivered as a ready-to-use dose, has the potential to expand access to PET-MPI, including improving diagnostic accuracy in patients who are difficult to image. with high body mass index and women.
Physicians emphasized Flyrcado’s unique clinical benefits such as high-quality imaging, resolution of major errors and improved workflow, vendor Stifel said ahead of the approval.
The use of Flyrcado helped to accurately classify 74% to 89% of the scans of the study participants.
GE HealthCare said Flyrcado delivers higher diagnostic efficiency in patients with known or suspected CAD, compared to SPECT MPI which is currently the most widely used procedure.
CAD is a narrowing or blockage of the coronary arteries, which supply oxygenated blood to the heart. It affects more than 18 million adults in the US, and is the leading cause of death in the country, according to the FDA.
The Flyrcado decays ten times less than currently approved cardiac PET radiotracers, says GE HealthCare, which could help combine exercise stress testing with imaging.
The company also has similar products for breast cancer and Alzheimer’s disease.
Stifel analysts estimate the approval of Flyrcado could add about 0.3% to 0.6% to the company’s sales growth in the medium to long term.
