FDA Approves Pediatric Use of Ultrasound-Enhancing Agent in Suboptimal Echocardiogram Cases
A recent pediatric clinical trial revealed that left ventricular opacification with the ultrasound agent Definity improved ejection fraction assessment for 80 percent of patients.
The Food and Drug Administration (FDA) has granted approval for the use of the ultrasound contrast agent Definity (perflutren lipid microsphere) in pediatric patients with suboptimal echocardiograms.
Through opacification of the left ventricular chamber on ultrasound, Definity facilitates improved visualization of the left ventricular endocardial border, according to Lantheus, the manufacturer of Definity.
Lantheus noted the FDA approval was based on findings from three pediatric clinical trials. One study demonstrated enhanced detection of wall motion abnormalities in 70 percent of patients and improved determination of ejection fraction in 80 percent of patients.
"While (Definity) has long demonstrated its effectiveness in providing better outcomes in adults over the past two decades, this new FDA decision offers a critical diagnostic tool for pediatric heart patients and their families,” said Kassa Darge, M.D., Ph.D, radiologist-in-chief and chair of the Department of Radiology at Children’s Hospital of Philadelphia. “This approval will offer a valuable alternative to pediatric cardiologists trying to do imaging work up in challenging pediatric cardiac cases.”
Newsletter
Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.
The Reading Room: Racial and Ethnic Minorities, Cancer Screenings, and COVID-19
November 3rd 2020In this podcast episode, Dr. Shalom Kalnicki, from Montefiore and Albert Einstein College of Medicine, discusses the disparities minority patients face with cancer screenings and what can be done to increase access during the pandemic.
FDA Clears Point-Of-Care Ultrasound Platform and AI Software for Neuraxial Procedures
July 17th 2025The dual FDA clearances for the Accuro 3S point-of-care ultrasound device and the SpineNav-AI machine learning-based software may enhance precision and safety with ultrasound-guided neuraxial procedures.
FDA Expands Approval of MRI-Guided Ultrasound Treatment for Patients with Parkinson’s Disease
July 9th 2025For patients with advanced Parkinson’s disease, the expanded FDA approval of the Exablate Neuro platform allows for the use of MRI-guided focused ultrasound in performing staged bilateral pallidothalamic tractotomy.
