Posted by Michael Wonder on 05 Nov 2019
GE Healthcare announces U.S. FDA approval of macrocyclic MRI contrast agent Clariscan (gadoterate meglumine) injection for intravenous use
4 November 2019 - Clariscan, approved in more than 55 countries globally with over four million patient doses shipped, is now FDA-approved in the U.S.
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 magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and paediatric patients to detect and visualise 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 to enhance the image and support diagnosis.
