• GE HealthCare’s agreement with CardioNavix, a part of the CDL Nuclear Technologies services group, further broadens the reach of Flyrcado.
• Through their nearly 225 U.S. customers, CDL and CardioNavix support more than 220,000 cardiac PET procedures annually.
• This agreement builds the capabilities needed to support Flyrcado’s growth in outpatient cardiac PET imaging by pairing CardioNavix’s comprehensive program setup, workflow, and clinical and operations support with GE HealthCare’s contract manufacturing organization (CMO) network to accelerate site enablement.

ARLINGTON HEIGHTS, Ill.--(BUSINESS WIRE)--Sep. 8, 2025-- GE HealthCare (Nasdaq: GEHC) today announced a Distribution and Services Agreement (DSA) with CardioNavix, a part of the CDL Nuclear Technologies services group that provides end-to-end cardiac positron emission tomography (PET) imaging solutions to hospitals and outpatient practices throughout the U.S. Through this agreement, GE HealthCare aims to bring Flyrcado™ (flurpiridaz F18) injection, its novel cardiac PET imaging agent, to patients nationwide, including private cardiology practices and office and hospital imaging settings, expanding the reach of cardiac PET for the evaluation of known or suspected coronary artery disease.

Around six million myocardial perfusion imaging (MPI) procedures are performed each year in the U.S.¹ Within that total, PET MPI represents roughly five to ten percent today², and is increasingly utilized by U.S. cardiology practices.³ By strengthening delivery in office-based care, this collaboration is expected to accelerate adoption of Flyrcado, which in the multi-center international Phase III AURORA trial demonstrated higher diagnostic efficacy versus SPECT MPI for detecting coronary artery disease.⁴

“This collaboration with CardioNavix is an important step in making Flyrcado available for patients nationwide, across all sites of care,” said Eric Ruedinger, vice president and general manager of GE HealthCare’s Pharmaceutical Diagnostics division for the U.S. and Canada. “CDL Nuclear Technologies is a trusted name in private cardiology and nuclear imaging, and today’s announcement underscores the confidence both organizations have in Flyrcado’s potential. This agreement helps establish the foundation needed to support GE HealthCare’s vision for Flyrcado’s growth in outpatient cardiac PET imaging and reinforces our commitment to innovation and patient-centered care.”

“We’re proud that CardioNavix will be the first distributor to bring Flyrcado to private practice cardiology,” said Lon Wilson, CEO of CDL Nuclear Technologies. “Through our nearly 225 customer sites, CDL and CardioNavix support around 220,000 patient procedures each year with end-to-end cardiac PET solutions—and that number continues to grow. Together with GE HealthCare, we’re helping more providers bring advanced cardiac PET to patients in both private office-based settings and hospitals.”

The DSA supports GE HealthCare’s long-term strategy to build the capabilities necessary for Flyrcado’s success in outpatient settings. Initial roll-out will begin in late 2025 and accelerate into broader expansion throughout 2026.

GE HealthCare’s Pharmaceutical Diagnostics division is a global leader in imaging agents used to support around 130 million procedures per year globally, equivalent to four patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products across cardiology, neurology and oncology, with an innovative pipeline, all aimed at enabling better informed diagnosis and monitoring for improved therapy decision making and clinical outcomes.

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™.

Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com for more information.

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; the rate of adoption and potential of Flyrcado; and the implementation and impact of the agreement. 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 implementation and impact of the agreement; 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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GE HealthCare Media Contact:
Emmy Elguizaoui
M +1 (978) 243-7503
emmy.elguizaoui@gehealthcare.com

Source: GE HealthCare Technologies Inc.