GE Healthcare Receives FDA Indication Approval for Imaging Agent
GE Healthcare has received an indication approval from the FDA for its imaging agent Visipaque (iodixanol) injection.
The solution is an iso-osmolar agent for use in coronary computed tomography angiography (CCTA) to assist in the diagnostis of adult and pediatric patients 12 years of age or older with suspected coronary artery disease.
The indication was approved based on data from the two studies showing that Visipaque has a 99 percent negative predictive value. — Cynthia Jessup