This approval will help improve the clarity and diagnostic accuracy of echocardiograms in pediatric patients, giving cardiologists a fuller picture of ventricular function when assessing possible heart abnormalities or disease.
“In some pediatric patients, standard echocardiography cannot produce sufficiently clear images of the heart, potentially hindering cardiologists’ ability to accurately diagnose underlying conditions,” said Jit Saini, MD, Chief Medical Officer of the Pharmaceutical Diagnostics (PDx) segment of GE HealthCare.
“This regulatory approval is a significant milestone that affirms the safety and efficacy of Optison in pediatric patients of all ages and expands our ability to offer this advanced imaging solution to a broader patient population. By facilitating more accurate measurement of left ventricular function, Optison enhances diagnostic capabilities, ultimately improving patient outcomes and providing greater value to healthcare providers and their patients.”
Optison contains gas-filled microbubbles that reflect ultrasound waves more effectively than surrounding tissues or blood, making the heart chambers and endocardial borders more visible, which is necessary for assessing heart conditions. Optison has a proven safety profile established over decades and is the only UEA available in the U.S. that does not contain polyethylene glycol (PEG). This allows it to be safely used by patients with PEG hypersensitivity, as PEG carries the potential to trigger anaphylaxis or hypersensitivity reactions in some patients.
“Ultrasound enhancing agents have significantly advanced diagnostic quality in adult echocardiography over the years, and we are now seeing promising research supporting their safe and effective use in pediatric patients,” said Arash Sabati, MD, FACC, pediatric cardiologist and non-invasive imaging specialist at Phoenix Children’s. “The availability of agents like Optison will further enhance diagnostic imaging for pediatric patients, helping to ensure the best possible care.”
Optison is currently indicated for use in patients with suboptimal echocardiograms. The FDA approved Optison for adults in 1997, and healthcare professionals have administered Optison to more than 5 million patients in the U.S.1.
As the first of the second generation of UEAs to be approved by the FDA, the approval for the pediatric indication follows GE HealthCare’s Phase IV, prospective open-label multicenter study to evaluate the efficacy of Optison for contrast-enhanced echocardiograms in patients. The study found that the use of intravenous Optison optimized endocardial border delineation, improved the visualization of left ventricular wall segments and reduced the number of suboptimal echocardiogram images in pediatric patients.
GE HealthCare’s PDx segment is a global leader in imaging agents which supported over 130 million patient procedures in 2024, equivalent to four patient procedures every second. For more than 40 years, GE HealthCare imaging agents have been routinely used across MRI, X-ray/CT and ultrasound to enhance clinical images and support diagnosis.
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.
