GE HealthCare’s Optison Ultrasound-Enhancing Agent Approved for Pediatric Indication

May 13, 2025—GE HealthCare announced that the FDA has approved a pediatric indication for the company’s Optison (perflutren protein-type A microspheres injectable suspension, USP) ultrasound-enhancing agent (UEA).

According to the company, the new 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.

GE HealthCare noted that the approval for the pediatric indication follows the company’s prospective open-label multicenter phase IV study that evaluated the efficacy of Optison UEA for contrast-enhanced echocardiograms in pediatric patients.

The study found that the use of intravenous Optison UEA optimized endocardial border delineation, improved the visualization of left ventricular wall segments, and reduced the number of suboptimal echocardiogram images in pediatric patients, reported the company.

Arash Sabati, MD, pediatric cardiologist and noninvasive imaging specialist at Phoenix Children’s Hospital in Phoenix, Arizona, commented on the approval in GE HealthCare’s press release.

“UEAs 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,” stated Dr. Sabati. “The availability of agents like Optison will further enhance diagnostic imaging for pediatric patients, helping to ensure the best possible care.”