GE HealthCare  announced that the FDA has granted approval of Flyrcado (flurpiridaz F 18) injection, a first of its kind positron emission tomography myocardial perfusion imaging (PET MPI) agent, for the detection of coronary artery disease (CAD).

GE HealthCare宣布，FDA已批准Flyrcado（flurpiridaz F 18）注射液，这是第一种正电子发射断层扫描心肌灌注成像（PET MPI）试剂，用于检测冠状动脉疾病（CAD）。

Indicated for patients with known or suspected CAD, Flyrcado delivers higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT) MPI, the predominant procedure used in nuclear cardiology today. Flyrcado, which can be manufactured in an offsite pharmacy and delivered as a ready-to-use unit dose, has the potential to expand clinician and patient access to PET MPI, including improving diagnostic accuracy in difficult-to-image patients such as those with a high body mass index (BMI) and women..

针对已知或疑似CAD的患者，与单光子发射计算机断层扫描（SPECT）MPI（当今核心脏病学中使用的主要程序）相比，Flyrcado具有更高的诊断功效。Flyrcado可以在场外药店生产，并以即用单位剂量提供，有可能扩大临床医生和患者对PET MPI的使用范围，包括提高难以成像的患者（如体重指数（BMI）高的患者）和女性的诊断准确性。。

With a half-life of 109-minutes—significantly longer than existing PET MPI tracers—Flyrcado removes the need for on-site tracer production and generator maintenance and enables distribution to a wide network of hospitals and imaging centers. This longer half-life also means Flyrcado brings the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD, enabling the most robust protocol for evaluating ischemia in patients.

。这种更长的半衰期也意味着Flyrcado带来了第一个将运动压力测试与心脏PET成像结合用于CAD的实际机会，从而为评估患者缺血提供了最可靠的方案。

Furthermore, clinicians would have the ability to rescan a patient during the same imaging session in the event of technical difficulties, rather than rescheduling an additional scan..

此外，如果出现技术困难，临床医生将能够在同一成像过程中重新扫描患者，而不是重新安排额外的扫描。。

Kevin O’Neill, CEO of the Pharmaceutical Diagnostics (PDx) segment of GE HealthCare, said, “As the first and only FDA-approved F 18 PET MPI radiotracer for CAD detection, Flyrcado can make a real difference to clinicians and their patients. This is another example of GE HealthCare’s commitment to innovating and investing to shape the future of molecular imaging, increasing diagnostic confidence and addressing unmet patient needs.”.

GE HealthCare药物诊断（PDx）部门首席执行官凯文·奥尼尔（KevinO'Neill）表示：“作为第一个也是唯一一个FDA批准用于CAD检测的F 18 PET MPI放射性示踪剂，Flyrcado可以为临床医生及其患者带来真正的改变。这是GE HealthCare致力于创新和投资以塑造分子成像的未来，提高诊断信心并解决未满足的患者需求的另一个例子。”。

Flyrcado will be available in initial U.S. markets in early 2025 with expanding availability thereafter.

Flyrcado将于2025年初在最初的美国市场上市，此后将扩大上市范围。

Condition: Imaging;PET/MPI

条件：成像；PET/MPI

Type: drug

类型：药物