GE HealthCare enhances cardiac diagnostics with innovative molecular imaging solutions showcased at SNMMI 2025

• GE HealthCare continues to advance precision care in cardiology through innovative molecular imaging solutions to help support early diagnosis, tailored treatments, and improved patient outcomes.

CHICAGO--(BUSINESS WIRE)-- GE HealthCare’s commitment to advancing precision care in cardiology through innovative molecular imaging solutions is on full display at this week’s Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting in New Orleans, Louisiana.

As cardiovascular disease (CVD) continues to rise globally,ⁱ the need for advanced diagnostic technologies becomes increasingly critical. GE HealthCare's molecular imaging technologies – including positron emission tomography-computed tomography (PET/CT) and single-photon emission computed tomography-computed tomography (SPECT/CT) – and radiopharmaceuticals – namely its Flyrcado™ (flurpiridaz F 18) injection – play a crucial role in cardiac care by providing detailed insights into biological processes beyond conventional imaging.

These advanced imaging techniques enable early diagnosis, precise assessment of myocardial perfusion and ischemia, and evaluation of infiltrative cardiomyopathies. By identifying specific pathologic processes, molecular imaging helps tailor treatments to individual patients, with the aim to enhance the effectiveness of therapies and improving prognosis. Additionally, it allows for monitoring treatment responses and disease progression, ultimately helping contribute to better patient outcomes.ⁱⁱ

“Flyrcado represents one of the most significant advancements in nuclear cardiology in decades,” shares Marcelo Fernando DiCarli, MD, Chief, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Executive Director, Cardiovascular Imaging Program, Departments of Radiology and Medicine, Brigham and Women's Hospital. “For the first time in nearly 20 years, we have a new PET myocardial perfusion tracer that brings the latest imaging technology within reach for patients across the U.S. The image quality is exceptional, and its use has the potential to reduce unnecessary invasive procedures by improving diagnostic confidence. I’ve found it to be a valuable addition to our clinical practice, enabling more personalized treatment strategies and better patient outcomes. The excitement across the cardiology community is evident as we enter a new era in precision cardiac care.”

GE HealthCare’s Flyrcado injection, a first-of-its-kind F 18-unit dose PET myocardial perfusion imaging (MPI) agent for patients with known or suspected coronary artery disease (CAD), helps clinicians deliver higher diagnostic efficacy compared to SPECT MPI, the predominant procedure used in nuclear cardiology today.

Recently launched in select U.S. markets, Flyrcado’s availability aligns with its receipt of CMS pass-through status, effective April 1, which includes a drug-specific HCPCS billing code to support efficient coding and Medicare coverage. In addition, Flyrcado is now covered by all seven Medicare Administrative Contractors (MACs) at either invoice price or better, depending on the site of care. More than 50% of commercially insured beneficiaries are now covered under updated national and regional cardiac PET policies that include Flyrcado as a covered benefit—marking significant progress in expanding access beyond the hospital outpatient setting. Further expansion is expected in the second half of the year as additional payors complete their policy reviews. To support this evolving access landscape, GE HealthCare has launched the Flyrcado Support Center (800-729-0701) to assist customers with benefits investigations, coding, coverage, and claims submissions.

“With coverage now in place for all traditional Medicare beneficiaries, along with updated PET coverage policies in place for more than half of the nation’s commercially insured beneficiaries, millions of Americans—many at risk for or living with coronary artery disease, the leading cause of death in the U.S.—will have greater access to this innovative technology,” said Eric Ruedinger, Vice President and General Manager of GE HealthCare’s Pharmaceutical Diagnostics division for the U.S. and Canada. “Flyrcado represents a significant advancement in cardiac care over SPECT imaging, offering clinicians a new, highly effective diagnostic tool to support more timely and personalized care for patients with known or suspected coronary artery disease.”

Flyrcado can be imaged with a range of PET/CT systems, including GE HealthCare’s Omni Legend, offering clinicians flexibility in integrating this innovative tracer into their existing imaging workflows. With Flyrcado, clinicians have 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.

Beyond Flyrcado, Omni Legend enables exceptional cardiac diagnostics, accommodating a range of tracers – including fast decay and emerging tracers. Representing a scalable PET/CT platform designed to evolve with healthcare system needs across care areas with shorter scan times and lower doses,ⁱⁱⁱ it continues to gain in popularity, representing the company’s fastest-ever-selling PET/CT.^iv

GE HealthCare is also proud to provide its StarGuide and Aurora SPECT/CT systems, designed to capture gamma rays emitted by radioactive tracers. Both systems offer exceptional image quality and scan time efficiency, supporting clinicians in making confident diagnoses. These features make SPECT/CT a valuable tool in cardiac care, providing comprehensive views of both physiological and structural aspects of diseases.

Additional solutions from GE HealthCare’s MIM Software are also available to enable multi-modality viewing and fusion of cardiac images and offer integration pathways for cardiac analysis.

A devoted provider of cardiology solutions, GE HealthCare supports the continuum of care and personalized treatments for the world’s largest hospitals to the smallest clinics and beyond the walls of the clinician’s office. With a vast and diversified portfolio, GE HealthCare offers healthcare professionals a breadth of solutions from early detection and diagnosis, to planning, intervention, and monitoring to help clinicians deliver better patient outcomes in cardiology care today and for the future.

For more information on GE HealthCare’s innovative portfolio of molecular solutions for cardiology, please visit gehealthcare.com. SNMMI show attendees are also encouraged stop by the company’s booth (#638 and #1023) at New Orleans Ernest N. Morial Convention Center in New Orleans, Louisiana from June 21-24.

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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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

• Risk associated with exercise or pharmacologic stress: Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizure. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent’s prescribing information.
• Radiation risks: FLYRCADO contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to patients and health care providers. Advise patients to hydrate before and after administration and to void.

Adverse reactions

• Most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia.

Use in specific populations

• Pregnancy
  • There are no data on use of flurpiridaz F 18 in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from flurpiridaz F 18 and the gestational timing of exposure.
  • FLYRCADO contains ethanol (a maximum daily dose of 337 mg anhydrous ethanol). If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy.
• Lactation
  • Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 8 hours after FLYRCADO administration.
• Pediatric Use
  • Safety and effectiveness of FLYRCADO in pediatric patients have not been established.

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.

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i World Health Organization. Cardiovascular diseases (CVDs). June 11, 2021. Available at: https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds). Accessed February 2023.

ii Ayalew, B. D., Rodoshi, Z. N., Patel, V. K., Alresheq, A., Babu, H. M., Aurangzeb, R. F., Aurangzeb, R. I., Mdivnishvili, M., Rehman, A., Shehryar, A., & Hassan, A. (2024, April 24). Nuclear cardiology in the era of precision medicine: Tailoring treatment to the individual patient. Cureus. https://pmc.ncbi.nlm.nih.gov/articles/PMC11127713/#:~:text=We%20also%20delved%20into%20the,integration%20in%20improving%20patient%20outcomes.

iii Omni Legend enables up to 40% PET dose reduction or up to 32% PET scan time reduction compared to Discovery MI 20 cm. As demonstrated in phantom testing.

iv Based on orders data of GE HealthCare PET/CT systems since 2010.

 

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GE HealthCare Media Contact:

Margaret Steinhafel

M +1 608 381 8829

margaret.steinhafel@gehealthcare.com

Source: GE HealthCare