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.”
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 Ultrasound AI Detection for Pleural Effusion and Consolidation
June 18th 2025The 14th FDA-cleared AI software embedded in the Exo Iris ultrasound device reportedly enables automated detection of key pulmonary findings that may facilitate detection of pneumonia and tuberculosis in seconds.
Ultrasound-Guided Thermal Ablation Shows Low Recurrence of Thyroid Carcinoma at Five Years
June 16th 2025In a meta-analysis involving over 2,200 patients with T1NoMo papillary thyroid carcinoma, researchers noted 2 percent recurrence and no cases of lymph node metastasis five years after ultrasound-guided thermal ablation.
