Guerbet’s Optiray Imaging Product Wins FDA Approval
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.