The U.S. Food and Drug Administration (FDA) has approved Clariscan, a macrocyclic, ionic, gadolinium-based, MRI contrast agent. Clariscan is indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
Clariscan has been approved in more than 55 countries globally and has had more than four million patient doses shipped in those countries. It is the latest in a growing range of imaging agents available in the U.S. from GE Healthcare. For more than 40 years, GE agents have been routinely used across MRI, X-ray/CT and ultrasound modalities to enhance the image and support diagnosis.
“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,” explained Kevin O’Neill, President & CEO Pharmaceutical Diagnostics at GE Healthcare.
“The FDA’s approval of this macrocyclic MR agent adds to the range of contrast media options available. and as radiologists we welcome this broader choice,” said Dr. Lawrence N Tanenbaum, M.D., FACR.
GE Healthcare offers diagnostic imaging agents used in approximately 90 million procedures per year globally, equivalent to three patients every second. In the U.S., GE Healthcare has a strong record of innovation in new contrast media products and indications, with recent FDA approvals for Omnipaque (iohexol) in CT of the abdomen and for Visipaque (iodixanol) in coronary CT angiography. GE Healthcare has invested $240 million in its global manufacturing and supply network over the past five years to deliver imaging agents to hospitals and pharmacies globally.
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