GE HealthCare Launches Flyrcado

Summary

GE HealthCare’s Flyrcado is a new PET imaging agent designed to detect coronary artery disease (CAD). It offers higher diagnostic efficacy than current methods and has received FDA approval and CMS pass-through status. This makes Flyrcado more accessible to patients and represents a significant advancement in cardiac care.

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** Main Story**

Just recently, GE HealthCare launched Flyrcado (flurpiridaz F 18) in the U.S., and it’s a game-changer for detecting coronary artery disease (CAD). If you were at the 2025 American College of Cardiology (ACC) Annual Scientific Session & Expo in Chicago, you probably saw it. Flyrcado uses positron emission tomography myocardial perfusion imaging (PET MPI), which gives a much clearer picture of blood flow to the heart compared to the current standard, single-photon emission computed tomography (SPECT) MPI.

Flyrcado: The Future of CAD Detection

CAD, where arteries narrow and restrict blood flow, it’s still a leading cause of death. Early and accurate detection is key for effective treatment and better outcomes. And that’s where Flyrcado shines, giving us a more precise way to spot CAD. You see, the FDA gave it the green light back in 2024, recognizing its potential to really improve cardiac imaging. The approval came after two big clinical trials that showed it was great at identifying significant CAD.

One of the coolest things about Flyrcado is its extended half-life of 109 minutes and that it comes in a unit dose format. What does that mean? Well, you don’t need to produce it on-site; specialized pharmacies can make it and deliver it as needed. This simplifies logistics and could really improve access to PET MPI, especially in areas that don’t have a ton of resources. Plus, if there are any technical hiccups during a scan, clinicians can just rescan the patient in the same session. Which means no rescheduling appointments. That’s a big win for everyone.

Better Healthcare Access For Everyone

Adding to the good news, the Centers for Medicare and Medicaid Services (CMS) granted Flyrcado pass-through status, starting April 1, 2025. This means there’s a specific billing code and coverage for Medicare beneficiaries, which will definitely increase patient access. It’s great that the FDA approval and CMS pass-through status happened around the same time, really showing how important Flyrcado is for improving CAD detection.

GE HealthCare: All About Innovation

Flyrcado just underscores GE HealthCare’s commitment to creating innovative medical tech. But it’s not just Flyrcado; they also announced AI-powered advancements and the Revolution Vibe CT system at ACC.25. The Revolution Vibe CT system has Unlimited One-Beat Cardiac imaging, combines advanced imaging with AI like ECG-less Cardiac, TrueFidelity DL, SnapShot Freeze 2, and Effortless Workflow. These improvements? They’re all about making diagnostics more accurate and workflows more efficient in cardiology, and ultimately, leading to better patient care.

Making PET MPI More Accessible

In the past, getting cardiac PET scans using other agents was tough. But Flyrcado’s longer half-life and unit dose format change that, allowing more people to get the benefits of PET MPI’s better accuracy. This improved access could significantly impact how we diagnose and manage CAD, particularly for patients who are difficult to image with traditional methods. For example, folks with a high BMI or women with dense breast tissue. For these patients, Flyrcado offers a more reliable and accurate way to detect CAD, which will mean quicker treatment. One patient told me about her experience with traditional imaging versus PET, and she wished she had access to PET sooner.

What’s Next for Cardiac Care?

Flyrcado is a real step forward in cardiac care, it’s a powerful new tool for healthcare professionals. Its combination of diagnostic accuracy, streamlined processes, and greater patient access makes it a very promising development in the fight against CAD. As it becomes more widely available, it has the potential to really change how clinicians diagnose and manage this common and life-threatening condition. GE HealthCare’s dedication to innovation is definitely shaping the future of cardiac care, and is helping patients and healthcare providers alike.

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