US FDA approves Guerbet’s Optiray imaging bulk package

Guerbet (GBT), a global leader in medical imaging, announced today that it received US Food and Drug Administration approval for the commercial sale of the Optiray® Imaging Bulk Package (IBP) in the United States, as well as FDA clearance of the LF IBP Transfer Set.

Guerbet’s Optiray IBP has the capability to fill sterile single-use syringes when used with a power injector and a cleared contrast media transfer set, Guerbet’s Optiray IBP presentation is an efficient option because it can reduce the number of single dose vials opened without requiring preparation in a laminar flow hood or pharmacy facility.

The Optiray IBP will be available in 500mL bottles in 2021 for the Optiray 320 and Optiray 350 concentrations

“Guerbet’s new Optiray IBP offers our customers the flexibility they seek in the CT suite, with a labeled maximum use time of 12 hours once pierced – presently the longest among iodinated contrast IBPs available in the US. Our innovative product portfolio continues to provide efficient solutions for healthcare providers and their patients,” said Thomas McLaughlin, VP, Guerbet North America. – PR Newswire