GE HealthCare Announces FDA Approval For Pediatric Use Of Optison Ultrasound Enhancing Agent

(RTTNews) - GE HealthCare (GEHC) announced Tuesday the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for the company's Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) ultrasound enhancing agent (UEA).

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.

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.

Optison is the only PEG-free ultrasound enhancing agent available in the U.S.