ARLINGTON HEIGHTS, Ill. — GE HealthCare has received U.S. Food and Drug Administration (FDA) approval for the use of its ultrasound enhancing agent, Optison™, in pediatric patients, expanding its application to help cardiologists diagnose heart conditions in children more effectively.
Optison, known for its ability to improve the quality of echocardiogram images, has been widely used in adult patients since its original approval in 1997. The new pediatric indication allows clinicians to use the agent to obtain clearer ultrasound images of the heart in children, particularly in cases where standard echocardiography fails to produce adequate visuals.
“In some pediatric cases, traditional ultrasound imaging does not yield sufficiently clear images, making it harder to accurately assess heart abnormalities,” said Dr. Jit Saini, Chief Medical Officer of GE HealthCare’s Pharmaceutical Diagnostics segment. “This approval underscores the safety and effectiveness of Optison in younger patients and broadens the diagnostic tools available to healthcare providers.”
Optison works by introducing gas-filled microbubbles into the bloodstream. These microbubbles reflect ultrasound waves, enhancing the visibility of heart structures, especially the endocardial borders, which are crucial for evaluating left ventricular function. The clearer imaging helps physicians more accurately detect and assess heart disease or other cardiac conditions.
Importantly, Optison is the only ultrasound enhancing agent available in the U.S. that does not contain polyethylene glycol (PEG), a compound known to cause hypersensitivity or anaphylactic reactions in some individuals. Its PEG-free composition makes it a safer option for patients with known allergies or sensitivities to the substance.
Dr. Arash Sabati, a pediatric cardiologist at Phoenix Children’s, noted the significance of the expanded indication, stating that “ultrasound enhancing agents have greatly improved diagnostic accuracy in adults, and this new approval for pediatric use will help deliver the same level of precision for children.”
The FDA’s decision was based on a Phase IV, open-label multicenter study evaluating Optison’s effectiveness in enhancing echocardiograms in pediatric patients. The study found that Optison significantly improved visualization of the heart’s internal structures, reduced the number of inconclusive images, and enhanced the ability to delineate the heart’s left ventricular wall.
GE HealthCare has long been a leader in medical imaging technologies. In 2024 alone, the company’s Pharmaceutical Diagnostics segment supported over 130 million patient procedures worldwide. The expansion of Optison’s indication reinforces the company’s commitment to broadening access to high-quality diagnostic tools across all patient populations, including children.
With this latest approval, Optison is expected to play an increasingly important role in pediatric cardiology, offering physicians a more effective way to detect heart conditions early and with greater accuracy.
