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There have been several recent advances with contrast media injector technology, including cutting costs by reducing contrast waste and automated data collection for the dose a patient receives. Automated injector systems not only precisely control the amount of contrast used; vendors have moved into the software/IT arena by offering personalized doses for patients using information pulled from an electronic medical record (EMR) or picture archiving and communication system (PACS). Contrast dose recording software also offers new possibilities for radiology departments looking to streamline and document their contrast media usage. Some vendors have now integrated X-ray radiation dose recording capabilities as well.
Guerbet will present its two latest contrast agents, Dotarem (gadoterate meglumine) injection and Lipiodol (ethiodized oil) injection, at the 100th annual Radiology Society of North America (RSNA) Nov. 30 through Dec. 6 in Chicago.
The use of contrast media in many imaging modalities continues to evolve as physicians seek to improve dose management practices and vendors churn out automated injectors that can precisely control the amount of contrast and personalize doses for patients using information pulled from an electronic medical record (EMR) or picture archiving and communication system (PACS). The features of today’s contrast media injectors include syringeless options and dose recording software, offering new possibilities for radiology departments looking to streamline and document their contrast media usage.
Guerbet announced a worldwide launch of FlowSens, a contrast agent injection solution used in X-ray medical examinations. FlowSens received CE marking in the first quarter of 2014. It will initially be marketed in Europe (first in Belgium, France, Germany and Switzerland), then gradually in other regions of the world.
Guerbet, a contrast agent specialist for medical imaging, received U.S. Food and Drug Administration (FDA) approval for a manufacturing plant for Lipiodol (ethiodized oil) Injection, in Montreal, Canada.
Guerbet announced that it has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for Lipiodol (Ethiodized Oil) Injection for management of patients with known hepatocellular carcinoma (HCC).
Guerbet has announced that Cincinnati Children's Hospital Medical Center (Cincinnati Children's) last week performed the first U.S. injection of Dotarem (gadoterate meglumine), the only macrocyclic and ionic gadolinium-based contrast agent (GBCA) approved by the U.S. Food and Drug Administration (FDA). The procedure was performed in a school age child.
Guerbet announced that the U.S. Food and Drug Administration (FDA) has approved Dotarem (gadoterate meglumine), a gadolinium-based contrast agent (GBCA) indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
Guerbet announced that the Medical Imaging Drugs Advisory Committee to U.S. Food and Drug Administration (FDA) has voted unanimously by votes of 17 to zero to recommend that FDA approve the New Drug Application (NDA) for Dotarem (gadoterate meglumine) for adults, and for pediatric use for children two years of age and older. The committee voted 10 to six (with one member abstaining) not to recommend at this time approval of the indication for children under two years of age.
Oxilan (Ioxilan Injection) is a contrast media for use in peripheral procedures because of its viscosity. Its reported low viscosity allows it to reach distal vessels. It also has the lowest osmolality of all nonionic monomers in the U.S. Together, these properties facilitate ease of injection, help improve patient comfort and provide visualization and image quality.