FDA Expands Approval Of MRI Contrast Agent For Children Under Two.

Jan 2015: Medscape (1/7, Anderson) reports that the FDA has approved “the first gadolinium-based MRI contrast agent, gadobutrol (Gadavist, Bayer Healthcare), for patients under two years of age.” The injectable agent is “used to detect and visualize areas with disrupted blood-brain barrier and/or abnormal vascularity of the central nervous system.” Gadavist was initially approved in 2011 for the same use in adults and children older than age two years.

Diagnostic Imaging (1/7, Haar) reports that Gadavist was also approved in June 2014 “for MRI of the breast to assess presence and extent of malignant breast disease.”

http://www.diagnosticimaging.com/contrast-agents/fda-approves-mri-contrast-agent-pediatric-patients

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