FDA approves popular ultrasound enhancing agent for pediatric patients
GE HealthCare has received U.S. Food and Drug Administration (FDA) approval of a new pediatric indication for its Optison ultrasound enhancing agent (UEA).
Optison was developed to improve the quality of suboptimal echocardiogram results, helping cardiologists learn as much as possible about a patient’s heart health. It contains gas-filled microbubbles that react with ultrasound waves in a way that increases visibility of the chambers of the heart and endocardial borders. Unlike other UEA options, Optison does not contain polyethylene glycol.
The FDA approved Optison for adult echocardiograms back in 1997. This update ensures pediatric patients with suboptimal imaging results can still receive the best care possible.
“In some pediatric patients, standard echocardiography cannot produce sufficiently clear images of the heart, potentially hindering cardiologists’ ability to accurately diagnose underlying conditions,” Jit Saini, MD, chief medical officer of GE HealthCare’s pharmaceutical diagnostics, said in a statement. “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.”
“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,” added Arash Sabati, MD, a pediatric cardiologist and noninvasive 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.”
This approval follows a GE HealthCare-funded analysis that found intravenous Optison consistently optimized endocardial border delineation, improved left ventricular wall segment visualization and reduced the risk of cardiologists being asked to interpret suboptimal imaging results.
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