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news.Bayer HealthCare Pharmaceuticals has received US Food and Drug Administration's approval for its Gadavist (gadobutrol) injection for the detection and visualization of areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system (CNS) in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older).
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According to Bayer HealthCare, Gadavist demonstrated improvement of visualization endpoints in paired Gadavist images compared to pre-contrast images resulted in improved assessment of normal and abnormal CNS anatomy in two Phase III trials.
Bayer HealthCare Commercial Operations John Rotondo said the approval of Gadavist enriches their portfolio of MRI contrast media and provides a new option for US healthcare providers in contrast-enhanced imaging of the CNS.