GE HealthCare Introduces Measures to Improve Cardiac Care Pathway

GE HealthCare today announced the U.S. launch of its Flyrcado (flurpiridaz F 18) injection. The company made the announcement as it prepares to showcase new artificial intelligence (AI)-powered innovations at the 2025 American College of Cardiology (ACC) Annual Scientific Session and Expo (March 29-31), reflecting its strategy to leverage AI to help increase efficiency and enable seamless data integration across the cardiology care pathway. 

GE HealthCare has been investing in AI for many years and has topped the U.S. Food and Drug Administration (FDA) list of AI-enabled device authorizations for three consecutive years with 85 authorizations.ⁱ

“The future of healthcare lies in the integration of advanced technologies with human expertise, allowing for a more holistic, data-driven and efficient cardiology care pathway,” said Eigil Samset, general manager of Cardiology Solutions at GE HealthCare. “Cardiovascular diseases are the leading cause of death globally, so it is critical that we continue our commitment to innovations in this space—our newest solutions showcased at ACC will help transform and optimize the diagnostic workflow.”

Flyrcardo U.S. Launch and CMS Pass-Through Status

Last year, the FDA approved Flyrcado for patients with known or suspected coronary artery disease (CAD), delivering higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT)ⁱⁱ myocardial perfusion imaging (MPI), the predominant procedure currently used in nuclear cardiology.

About 6 million MPI procedures are undertaken each year in the United Statesⁱⁱⁱ to show blood flow through the heart muscle and evaluate the presence, extent and degree of myocardial ischemia or infarction. Positron emission tomography (PET) is the most effective form of MPI for detecting CAD^iv and is recommended for a wide range of patients, including those considered more challenging to diagnose, such as individuals with a BMI greater than 30 or women, especially those with dense breasts,^v over SPECT MPI. With its 109-minute half-life, Flyrcado can be ordered as a ready-to-use unit dose and offers clinicians the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD, providing a highly effective protocol for evaluating ischemia in patients.

Today’s announcement about Flyrcado—a first-of-its-kind unit dose PET MPI agent—coincides with the product’s pass-through status by the Centers for Medicare and Medicaid (CMS) effective April 1. The pass-through status secures a drug-specific Healthcare Common Procedure Coding System (HCPCS) billing code for Flycardo and coverage for traditional Medicare beneficiaries. Pass-through payment status—typically granted to facilitate patient access to innovative devices and drugs—will enable CMS to provide separate payments for the radiopharmaceutical and the PET-CT scan, when performed with Flyrcado in the hospital outpatient setting.

“The launch of Flyrcado represents a significant advancement in cardiac care, providing a new, highly effective diagnostic tool for those with known or suspected coronary artery disease,” said Eric Ruedinger, vice president and general manager of GE HealthCare’s Pharmaceutical Diagnostics segment for the U.S. and Canada. “With the grant of pass-through status by CMS, and the official commercial launch of Flyrcado, we are pleased that millions of patients throughout the U.S. will have access to this technology, which will help improve diagnostic accuracy and may lead to better patient outcomes.”

Flyrcado will officially be unveiled at ACC on March 29 (booth #9013), and throughout the conference, clinicians from several clinical trial and early adopter sites will participate in learning lab sessions, stage talks, and ‘Meet the Expert’ breakout sessions to share their experiences and insights on using Flyrcado. You can learn more about these events and how to participate here.

Additional innovations highlighted at ACC 2025:

• The latest version of CASE (Cardiac Assessment System for Stress Testing), powered by GE HealthCare’s CardioSoft technology, will be unveiled at ACC on March 30. CASE is designed to enable clinicians to unlock insights quickly while ensuring seamless data flow, which could be critical for cardiac patients. The scalable portfolio provides on-demand access to high-quality ECG data and integrates into existing workflows. The advanced tools of CASE are aimed to support diverse cardiovascular disease patients, empower confident diagnosis and assist clinicians to promptly place patients on the appropriate care pathway.
• CardIQ Suite is an integrated workflow for the seamless review of calcium scoring and cardiac computed tomography angiography (CCTA) data. The suite features a fully automated calcium scoring algorithm that quickly identifies calcium burden and location, providing both total and per territory scores within seconds, and includes the ability to visualize and estimate the volume of heart fat.^vi Additionally, readers can immediately proceed to the CCTA read using advanced 2D and automated 3D processing tools as well as enjoy automated coronary segmentation and tracking AI algorithms to significantly reduce the need for manual intervention, enhancing efficiency with ready-to-read multi-planar images.
• The recently introduced AltiX AI.i edition of Mac-Lab, CardioLab, and ComboLab editions aim to improve the user experience, elevate workflow in the cardiac catheterization lab and support even the most complex electrophysiology procedures. The AltiX AI.i edition of Mac-Lab, CardioLab and ComboLab is designed to enhance efficiency and precision care for multiple types of cardiac procedures. These latest editions offer new features that streamline workflow and enhance interoperability, while upholding strong cybersecurity standards. AltiX AI.i is available for order in the U.S. and is expected to launch in global markets later this year.^vii

GE HealthCare is a global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services, and data analytics. The company aims to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient’s journey across care pathways. Together, its Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. The $19.7 billion business employs roughly 53,000 workers.

References
ⁱ “Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices,” December 20, 2024, https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices
ⁱⁱ Maddahi, J, Agostini, D, Bateman, T. et al. Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients With Suspected Coronary Artery Disease. JACC. 2023 Oct, 82 (16) 1598–1610. https://doi.org/10.1016/j.jacc.2023.08.016
ⁱⁱⁱ Miller, R. J. H., Bednarski, B. P., Pieszko, K., Kwiecinski, J., Williams, M. C., Shanbhag, A., Liang, J. X., Huang, C., Sharir, T., Hauser, M. T., Dorbala, S., Di Carli, M. F., Fish, M. B., Ruddy, T. D., Bateman, T. M., Einstein, A. J., Kaufmann, P. A., Miller, E. J., Sinusas, A. J., Acampa, W., Han, D., Dey, D., Berman, D. S., & Slomka, P. J. (2024). Clinical phenotypes among patients with normal cardiac perfusion using unsupervised learning: A retrospective observational study. EBioMedicine, 99, 104930. https://doi.org/10.1016/j.ebiom.2023.104930
^iv 1. Driessen RS, Raijmakers PG, Stuijfzand WJ, Knaapen P. Myocardial perfusion imaging with PET. Int J Cardiovasc Imaging. 2017;33(7):1021-1031.
^v Bateman TM, Dilsizian V, Beanlands RS, DePuey EG, Heller GV, Wolinsky DA. American Society of Nuclear Cardiology and Society of Nuclear Medicine and Molecular Imaging Joint Position Statement on the Clinical Indications for Myocardial Perfusion PET. J Nucl Med . 2016;57(10):1654-1656.
^vi CardIQ Suite is 510(k) pending at the U.S. FDA. It is not CE marked. Not available for sale in the U.S. or EU countries.
^vii AltiX AI.i is 510(k) cleared and CE mark pending.