The U.S. Food and Drug Administration (FDA) has approved flurpiridaz F-18, a new positron emission tomography (PET) radiotracer from GE HealthCare, branded as Flyrcado, for detecting coronary artery disease (CAD). This innovative imaging technology is expected to enhance nuclear imaging capabilities, providing improved diagnostic efficacy over traditional single-photon emission computed tomography (SPECT) methods, especially beneficial for patients with high body mass index and other challenging imaging profiles. The approval is viewed as a significant advancement in nuclear cardiology, potentially increasing access to PET imaging and facilitating exercise stress testing in cardiac assessments. Flurpiridaz boasts a longer half-life than existing PET tracers, which simplifies its distribution and availability. It is projected to reduce costs tied to PET imaging and expand the utilization of PET in medical centers. This approval follows promising results from clinical trials, showing flurpiridaz's superior diagnostic sensitivity compared to SPECT. The tracer will be rolled out in select U.S. markets in early 2025, with broader availability expected by the end of that year. Additionally, changes to the payment structure proposed by the Centers for Medicare and Medicaid Services could further incentivize the adoption of PET technologies, making them more appealing to healthcare facilities.
Fri, 27 Sep 2024 22:00:00 GMT | Cardiovascular Business