Flurpiridaz F 18

GE HealthCare (Nasdaq: GEHC) + says its Flyrcado (flurpiridaz F 18) PET imaging agent injection is now available in select U.S. markets. The Chicago-based medtech giant made the announcement at the 2025 American College of Cardiology (ACC) Annual Scientific Session & Expo, which is taking place March 29–31 in Chicago. The company describes Flyrcado as a first-of-its-kind unit dose positron emission tomography myocardial perfusion imaging (PET MPI) agent. The FDA approved it last year as a radioactive diagnostic drug for people with known or suspected coronary artery disease (CAD). GE HealthCare says it delivers higher diagnostic efficacy compared to single-photon emission computed tomography myocardial perfusion imaging. The Flyrcado launch coincides with pass-through status by the CMS, effective April 1, which secures a drug-specific Healthcare Common Procedure Coding System (HCPCS) billing code and coverage for traditional Medicare beneficiaries. “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,” Eric Ruedinger, VP and GM of GE HealthCare’s Pharmaceutical Diagnostics segment for the U.S. and Canada, said in a news release. “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.” GE HealthCare is also using ACC 2025 to highlight new AI-powered innovations for cardiac care: The latest version of CASE (Cardiac Assessment System for Stress Testing), powered by the company’s CardioSoft  technology and designed to enable clinicians to unlock insights quickly; CardIQ Suite, an integrated workflow for better review of calcium scoring and cardiac computed tomography angiography (CCTA) data; Recently introduced AltiX AI.i edition of Mac-Lab, CardioLab and ComboLab editions to improve user experience and elevate workflow in the cardiac catheterization lab and support complex electrophysiology procedures. “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, GM 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.”

An expansion in Ireland falls under the purview of GE HealthCare’s pharmaceutical diagnostics arm, which produces radiopharmaceuticals in addition to molecular imaging agents and contrast media.\n Eyeing an expected leap in demand for contrast media—used in X-rays, CT scans and more—GE HealthCare is upping its stake in the Emerald Isle.The company is pumping $138 million into its Carrigtwohill fill-finish site in County Cork, Ireland, to build a new facility that will help deliver 25 million more contrast media doses per year by the end of 2027.The 3,000-square-meter (32,292-square-foot) manufacturing plant will be designed to help produce both commercial products and those from GE HealthCare’s pipeline, the company said. The site will come equipped with solution preparation vessels, multifunctional power handling systems, a new filling line and autoclaves—all underpinned by automation systems.The expansion falls under the purview of its pharmaceutical diagnostics arm, which produces radiopharmaceuticals in addition to molecular imaging agents and contrast media. To hear GE HealthCare tell it, the global demand for iodine-based contrast media—injections that enhance the visualization of organs, blood vessels and tissues during real-time medical imaging—is expected to double within the next decade due to an aging population and the growing prevalence of chronic disorders.Aside from the site in Carrigtwohill, GE HealthCare also cranks out contrast media at fill-finish production campuses in Shanghai and Oslo.“This expansion strengthens our longstanding presence in Cork, where we have a highly skilled team, access to leading talent in the pharmaceutical industry, strong distribution links around the world and a great partnership with IDA Ireland,” Eugene Barrett, site leader and managing director for GE HealthCare Ireland, said in a statement. “First doses from our new facility are expected by the end of 2027 and we are proud of the impact our site will continue to make for patients around the world.” GE Healthcare had a busy end to 2024.In addition to picking up an FDA nod for its PET scan imaging tracer Flyrcado, the company also unveiled its new artificial-intelligence-powered Pristina Via mammography system, inked an AI collaboration with RadNet and announced plans to take full control of radiopharmaceutical and molecular imaging firm Nihon Medi-Physics.More recently, GE revealed earlier this month at the J.P. Morgan Healthcare Conference that it’s launching a new imaging research collaboration with the University of California, San Francisco. The team-up will see the partners work to develop automated imaging methods, including MRI techniques, for neurodegenerative diseases and cancer.Elsewhere, multiple pharma majors have made manufacturing inroads into Ireland in recent years.Last September, Eli Lilly revealed an $1.8 billion investment to expand production capacity at a pair of Irish plants in Limerick and Kinsale. The Limerick plant, which is under construction, will help crank out biologic active ingredients, including those for Lilly’s Alzheimer’s drug Kisunla, while the Kinsale facility produces the drugmaker’s tirzepatide products Mounjaro and Zepbound.Plus, Bristol Myers Squibb in early 2024 blueprinted a $400-million investment at its Dublin 15 Cruiserath campus in Ireland, which will both help produce existing medicines and serve as a “launch excellence facility.” The project, which BMS plans to wrap up by 2026, is expected to create 350 new jobs concurrent with the plant build-out.Multiple other large drugmakers like Pfizer, Novo Nordisk and Astellas also maintain manufacturing footprints in the country.