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Home » Guerbet’s Optiray Imaging Product Wins FDA Approval
Guerbet’s Optiray Imaging Product Wins FDA Approval
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Guerbet has received FDA approval for its Optiray Imaging Bulk Package (IBP) and marketing clearance for its accompanying media transfer set, used for filling single-use syringes with an iodine-based diagnostic agent.
The radiographic dye enables CT imaging of the head and body, as well as imaging for venography, urography and angiography.
The France-based company says the Optiray IBP offers more flexibility because it can be used for up to 12 hours once opened, longer than other iodinated-contrast IBPs currently available in the U.S.
The company said it will make the bulk dye product available in 500ml bottles next year.
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