As the company announced on Friday, the US Food and Drug Administration (FDA) has approved the diagnostic GEHC approved by GE HealthCare for the detection of coronary artery disease.
Flyrcado, a radioactive diagnostic for positron emission tomography (PET) myocardial perfusion imaging (MPI), will be available in some U.S. markets in early 2025 before expanding to additional markets.
PET-MPI is a non-invasive imaging test that uses a type of nuclear medicine radioactive tracer to determine how well blood flows to the heart muscle. 3D images of the tracer distribution can then be created.
According to the company, Flyrcado, which can be manufactured at an outside pharmacy and delivered as a ready-to-use unit dose, has the potential to expand access to PET-MPI and improve diagnostic accuracy in patients who are difficult to image, such as: B. Patients with a high body mass index and women.
Doctors have highlighted the clear clinical benefits of Flyrcado, such as: B. the higher quality of the imaging, the better resolution of defects and the improvement of the workflow, said the broker Stifel in a statement ahead of the approval.
The use of Flyrcado helped accurately classify 74 percent to 89 percent of study participants’ scans.
According to GE HealthCare, Flyrcado provides greater diagnostic effectiveness in patients with known or suspected CAD compared to SPECT MPI, the most commonly used procedure today.
CAD is a narrowing or blockage of the coronary arteries that supply oxygen-rich blood to the heart. It affects over 18 million adults in the United States and, according to the FDA, it is the leading cause of death in the United States.
Flyrcado decays 10 times slower than currently approved cardiac PET radiotracers, according to GE HealthCare, which can facilitate the combination of stress testing and imaging.
The company also has similar products for breast cancer and Alzheimer’s disease detection.
Stifel analysts estimate that Flyrcado’s approval could provide the company with revenue growth of 0.3 percent to 0.6 percent in the medium to long term.
