The U.S. FDA has approved Clariscan, a macrocyclic, ionic, gadolinium-based, MRI contrast agent, expanding the GE Healthcare portfolio for U.S. patients and radiologists. Clariscan is a gadolinium-based contrast agent indicated for intravenous use with MRI in brain, spine and associated tissues in adult and pediatric patients to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity.

“Demand for contrast media has significantly increased over the past decade. The introduction of Clariscan increases our clinical offering for U.S. radiologists, enhancing visualization to provide better patient care. Our customers rely on our high-quality products, first-rate supply network, and surrounding services to support their day-to-day work,” says Kevin O’Neill, president and CEO pharmaceutical diagnostics at GE Healthcare.

Clariscan is manufactured in Norway using a proprietary manufacturing process. As with all GE Healthcare contrast media products, all stages of manufacturing, from development of the active pharmaceutical ingredient to finished product, are managed entirely by GE Healthcare.

Clariscan is available in single dose vials of 10, 15 and 20 mL. The packaging contains a 2D data matrix (barcode) on every Clariscan pack, which conveys key information, including national drug code number, individual lot number, and expiration date. This information can be easily scanned and uploaded onto electronic medical systems, helping to reduce the risk of manual data entry errors and helping workflow efficiencies at medical centers.