FDA approves GE Healthcare’s MRI contrast agent for US use

The Food and Drug Administration recently approved Clariscan, an injectable MRI contrast agent, for use in the United States, GE Healthcare announced Monday, Nov. 4.

Clariscan is a gadolinium-based agent indicated for IV use in brain, spine and associated tissues to help detect areas with disruption of the blood brain barrier, or abnormal vascularity. It’s already been approved for use in more than 55 countries worldwide, with 4 million doses shipped.

“Demand for contrast media has significantly increased over the past decade,” Kevin O’Neill, president and CEO of pharmaceutical diagnostics at GE Healthcare, said in a prepared statement. “The introduction of Clariscan increases our clinical offering for U.S. radiologists, enhancing visualization to provide better patient care.”

The contrast agent is currently manufactured in Norway, with all stages managed by GE Healthcare. It is available in single-dose vials of 10, 15 and 20 mL, according to the announcement.