United States: Guerbet receives FDA Approval for the OptiOne™ Delivery System
Guerbet receives FDA 510k clearance for the OptiOne™ Single-Head Contrast Delivery System.
The American Food and Drug Administration (FDA) has authorized the commercialization of the OptiOne™ Single-Head Contrast Delivery System in the United States.
The OptiOne™ is an entry-level single-head injector launched in 2015 on the European market, available in ceiling-suspended and pedestal form. It is designed for the injection of radiopaque contrast agents in the vascular system of patients to obtain diagnostic images in CT scan examinations. The OptiOne™ will be displayed at the upcoming European Congress of Radiology (ECR).
The OptiOne™ is manufactured by Cincinnati, OH-based Liebel-Flarsheim, a company acquired by Guerbet as part of its purchase of Mallinckrodt’s Contrast Media and Delivery Systems (CMDS) business announced on November 27, 2015.
“The US approval for OptiOne™ builds upon Guerbet’s commitment to be a global leader specializing in contrast media and imaging solutions and services”, said Massimo Carrara, US General Manager for Guerbet LLC.