CHICAGO, March 27, 2025--(BUSINESS WIRE)--GE HealthCare (Nasdaq: GEHC) today announced the U.S. launch of Flyrcado™ (flurpiridaz F 18) injection at the 2025 American College of Cardiology (ACC) Annual Scientific Session & Expo, taking place March 29-31 in Chicago. Additionally, the company will showcase new AI-powered innovations, reflecting its strategy to leverage AI to help increase efficiency and enable seamless integration of data across the cardiology care pathway. GE HealthCare has been investing in AI for years and has topped the FDA list of AI-enabled device authorizations for three years in a row 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."
Flyrcado U.S. launch and U.S. Centers for Medicare and Medicaid (CMS) pass-through status
In 2024, 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 used in nuclear cardiology today.
Around six million MPI procedures are undertaken each year in the U.S.iii to show blood flow through the heart muscle and evaluate the presence, extent and degree of myocardial ischemia or infarction. PET is the most effective form of MPI for detecting CADiv 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 breastsv, 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, GE HealthCare announced the commercial launch of Flyrcado, a first-of-its-kind unit dose positron emission tomography myocardial perfusion imaging (PET MPI) agent, now available in select U.S. markets. This launch coincides with the receipt of pass-through status by the CMS, effective April 1st, securing a drug-specific Healthcare Common Procedure Coding System (HCPCS) billing code 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 innovative technology, which will help improve diagnostic accuracy and may lead to better patient outcomes."
Flyrcado will be unveiled at ACC on Saturday, March 29, and throughout the conference, clinicians from several clinical trial and early adopter sites will participate in learning lab sessions, innovation 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:
To learn more about the cardiology innovations GE HealthCare will be featuring at ACC 2025, please visit the events page here or stop by booth #9013.
Forward-Looking Statements
This release contains forward-looking statements. These forward-looking statements might be identified by words, and variations of words, such as "will," "expect," "may," "would," "could," "plan," "believe," "anticipate," "intend," "potential," and similar expressions. These forward-looking statements may include, but are not limited to, statements about Flyrcado and GE HealthCare Technologies Inc.’s (the "Company’s") performance, growth opportunities, and strategy. These forward-looking statements involve risks and uncertainties, many of which are beyond the control of the Company. Factors that could cause the Company’s actual results to differ materially from those described in its forward-looking statements include, but are not limited to, uncertainties regarding the commercial success of Flyrcado, the Company’s ability to receive pass-through status from the US Centers for Medicaid and Medicare, and decisions by regulatory authorities impacting labeling, manufacturing processes, safety, or other matters that could affect the availability or commercial potential of Flyrcado. Other factors that may cause such a difference also include those discussed in the "Risk Factors" section of the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission and any updates or amendments it makes in future filings. There may be other factors not presently known to the Company or which it currently considers to be immaterial that could cause the Company’s actual results to differ materially from those projected in any forward-looking statements the Company makes. The Company does not undertake any obligation to update or revise its forward-looking statements except as required by applicable law or regulation.
Important Safety Information and Usage of Flyrcado™ (flurpiridaz F 18) injection
FLYRCADO™ (flurpiridaz F 18) injection, for intravenous use important safety information
Indications and Usage
FLYRCADO is a radioactive diagnostic drug indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction.
Contraindications
None
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 800-FDA-1088 or www.fda.gov/medwatch
For full prescribing information, click here. For important safety information, please click here.
About GE HealthCare Technologies Inc.
GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim 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, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits.
GE HealthCare is proud to be among 2025 Fortune World’s Most Admired Companies™.
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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.
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Contacts
GE HealthCare Media Contact:
Karin Dalsin
Global Communications Director
M +1 612-219-2855
karin.dalsin@gehealthcare.com
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