GE Healthcare has received U.S. Food and Drug Administration (FDA) clearance for a new indication for its Visipaque contrast agent.
The iso-osmolar agent is now approved for use in coronary CT angiography (CCTA) to assist in the diagnostic evaluation of adults and pediatric patients 12 years or older with suspected coronary artery disease.
Radiologists and cardiologists have traditionally used invasive coronary angiography procedures to diagnose potential coronary artery disease in patients, but the new Visipaque indication allows for imaging the coronary arteries of these patients in an outpatient CCTA procedure, according to the vendor.
