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FDA Okays Macrocyclic MRI Contrast Agent Clariscan Injection For Intravenous Use

GE Healthcare said Monday that the U.S. Food and Drug Administration 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 magnetic resonance imaging or 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 or 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.

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