CHICAGO--(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:

The latest version of CASE™ (Cardiac Assessment System for Stress Testing), powered by our CardioSoft™ technology, will be unveiled at ACC on Sunday, 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