GE HealthCare Technologies Inc. GEHC recently announced the U.S. launch of Flyrcado (flurpiridaz F 18) injection at the ongoing American College of Cardiology (ACC) Annual Scientific Session & Expo. It also plans to unveil the latest version of CASE (Cardiac Assessment System for Stress Testing), powered by its CardioSoft technology, at the ACC.
GE HealthCare also plans to showcase CardIQ Suite (an integrated workflow for the seamless review of calcium scoring and cardiac computed tomography angiography data) and its recently launched AltiX AI.i edition of Mac-Lab, CardioLab and ComboLab editions.
GEHC aims to highlight its strategy to leverage AI to help increase efficiency and enable seamless integration of data across the cardiology care pathway by showcasing its latest AI-powered innovations.
The latest launch is expected to significantly strengthen GE HealthCare’s Cardiology Solutions unit, thus boosting its overall business.
Per GE HealthCare’s estimates, around six million myocardial perfusion imaging (MPI) procedures are undertaken each year in the United States to show blood flow through the heart muscle and evaluate the presence, extent and degree of myocardial ischemia or infarction. Positron emission tomography (PET) is currently the most effective form of MPI for detecting coronary artery disease (CAD) and is recommended for a wide range of patients, including those considered more challenging to diagnose, over single-photon emission computed tomography (SPECT) MPI.
GEHC further stated that the FDA approved Flyrcado for patients with known or suspected CAD in 2024. This is expected to deliver higher diagnostic efficacy, unlike SPECT MPI, the predominant procedure used in nuclear cardiology at present.
GE HealthCare’s management believes that the launch of Flyrcado represents a significant advancement in cardiac care, providing a new, highly effective diagnostic tool for those with known or suspected CAD.
Additionally, Flyrcado has been granted traditional pass-through payment status by the U.S. Centers for Medicare and Medicaid (CMS). The receipt of pass-through status from the CMS, effective April 1, secures a drug-specific Healthcare Common Procedure Coding System or HCPCS billing code and coverage for traditional Medicare beneficiaries. Pass-through payment status will likely enable CMS to provide separate payments for radiopharmaceutical and PET-CT scan, when performed with Flyrcado in the hospital outpatient setting.
Per a report by Grand View Research, the global coronary heart disease diagnostic imaging device market was estimated to be $2 billion in 2024 and is anticipated to witness a CAGR of 6.6% between 2025 and 2030. Factors like the increasing prevalence of CAD and the rising adoption of early diagnostic techniques are likely to drive the market.
Given the market potential, the latest product availability is expected to provide a significant boost to GE HealthCare’s business.
This month, GEHC announced the launch of the AltiX AI.i edition of Mac-Lab, CardioLab and ComboLab. The AltiX AI.i edition is expected to enhance efficiency and precision care for multiple types of cardiac procedures.
GEHC’s peer in the cardiovascular space, Merit Medical Systems, Inc. MMSI, announced the enrollment of the first patient in its multicenter, prospective study of the Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in premature infants (PREEMIE study) this month. Per Merit Medical, the Bloom Micro Occluder System was designed as a minimally invasive option for treating hemodynamically significant PDA. The PREEMIE study has been developed to evaluate its safety and efficacy.
Last month, Merit Medical reported its fourth-quarter 2024 results, wherein its Cardiovascular unit and all its product categories reported robust revenue growth.
Another player and GE HealthCare’s peer in the cardiovascular space is Medtronic plc MDT. This month, Medtronic released the two-year positive results of the Small Annuli Randomized To Evolut or SAPIEN (SMART) Trial, the largest international head-to-head comparative trial of transfemoral transcatheter aortic valve replacement.
Last month, Medtronic reported its third-quarter fiscal 2025 results, wherein its Cardiovascular Portfolio witnessed a robust revenue uptick on both reported and organic basis.
Another renowned peer in the cardiovascular space is Abbott Laboratories ABT. This month, ABT announced the receipt of the CE Mark in Europe for the Volt PFA System to treat patients battling atrial fibrillation. Following this, Abbott has begun commercial PFA cases in the European Union (EU) with physicians who are familiar with the Volt PFA System within its PFA clinical studies. ABT plans to further expand the use of Volt in EU markets throughout the second half of the year.
Abbott also announced this month that the FDA has approved an investigational device exemption for its Coronary Intravascular Lithotripsy System to evaluate the treatment of severe calcification in coronary arteries prior to stenting.
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