Gadoteric acid

GE HealthCare Expands Contrast Media Portfolio with Launch of MRI Agent Pixxoscan (gadobutrol)

Retrieved on: 
Thursday, April 27, 2023
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GE HealthCare has today announced the launch of Pixxoscan (gadobutrol), its macrocyclic, non-ionic Magnetic Resonance Imaging (MRI) gadolinium-based contrast agent (GBCA).

Key Points: 
  • GE HealthCare has today announced the launch of Pixxoscan (gadobutrol), its macrocyclic, non-ionic Magnetic Resonance Imaging (MRI) gadolinium-based contrast agent (GBCA).
  • Pixxoscan facilitates visualization of abnormal structures or lesions and helps in the differentiation between healthy and pathological tissue.
  • Pixxoscan adds to GE HealthCare’s MRI contrast media portfolio which includes macrocyclic Clariscan (gadoteric acid) as well as Rapiscan, used in stress cardiac MR to aid diagnosis of coronary artery disease and offering an alternative for patients who cannot exercise.
  • For more than 40 years, GE HealthCare imaging agents have been routinely used across MRI, X-ray/CT and ultrasound to enhance clinical images and support diagnosis.

Fresenius Kabi Expands Contrast Agent Portfolio with Launch of Gadoterate Meglumine Injection, USP

Retrieved on: 
Tuesday, October 4, 2022
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Fresenius Kabi announced today it has launched Gadoterate Meglumine Injection, USP, a bioequivalent and therapeutic equivalent substitute for the contrast agent Dotarem.

Key Points: 
  • Fresenius Kabi announced today it has launched Gadoterate Meglumine Injection, USP, a bioequivalent and therapeutic equivalent substitute for the contrast agent Dotarem.
  • View the full release here: https://www.businesswire.com/news/home/20221004005162/en/
    Fresenius Kabi Gadoterate Meglumine Injection, USP is an FDA-approved generic for MRI procedures that is fully substitutable for Dotarem.
  • Fresenius Kabi is pleased to expand our contrast agent portfolio and our support for the radiology community with the launch of Gadoterate Meglumine Injection, USP, said John Ducker, president and CEO of Fresenius Kabi USA.
  • Contrast agents are vital to patient diagnosis, and the addition of Fresenius Kabi Gadoterate Meglumine will provide hospitals and clinics across the U.S. with more high-quality choices to support patient care.

FDA Approves Bracco Diagnostic Inc.'s ProHance® (Gadoteridol) Injection, 279.3 mg/mL, for Pediatric Patients Younger than Two Years

Retrieved on: 
Wednesday, December 23, 2020
Anatomy, Medical specialties, Cryogenics, Magnetic resonance imaging, Acute kidney injury, Branches of biology, Gadoteric acid, MRI contrast agent

ProHance (Gadoteridol) Injection, 279.3 mg/mL is indicated for use in MRI in adults to visualize lesions in the head and neck.

Key Points: 
  • ProHance (Gadoteridol) Injection, 279.3 mg/mL is indicated for use in MRI in adults to visualize lesions in the head and neck.
  • Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities.
  • The risk for NSF appears highest among patients with:
    Screen patients for acute kidney injury and other conditions that may reduce renal function.
  • No case of NSF associated with ProHance or any other GBCA has been identified in pediatric patients ages 6 years and younger.

GE Healthcare’s Clariscan™ (gadoterate meglumine) Becomes Only FDA-Approved MRI Contrast Agent Available in Polymer Bottle

Retrieved on: 
Tuesday, September 15, 2020
Biotechnology, FDA, Medical devices, Health, Pharmaceutical, Physical sciences, Chemistry, Materials, MRI contrast agent, Gadoteric acid, Gadolinium, Contrast agent, Magnetic resonance imaging, GE Healthcare, General Electric, Gado, Biotechnology, FDA, Medical devices, Health, Pharmaceutical, Physical sciences, Chemistry, Materials, MRI contrast agent, Gadoteric acid, Gadolinium, Contrast agent, Magnetic resonance imaging, GE Healthcare, General Electric, Gado

GE Healthcares innovative shatterproof polymer +PLUSPAK Pharmacy Bulk Package has been approved by the US FDA for use with its macrocyclic gadolinium-based MRI contrast agent, Clariscan (gadoterate meglumine).

Key Points: 
  • GE Healthcares innovative shatterproof polymer +PLUSPAK Pharmacy Bulk Package has been approved by the US FDA for use with its macrocyclic gadolinium-based MRI contrast agent, Clariscan (gadoterate meglumine).
  • As the only FDA approved MRI contrast agent in a polymer bottle, Clariscan in +PLUSPAK will offer MRI departments a variety of ways in which they can improve safety and workflow efficiency.
  • Many radiology departments have already experienced the benefits of +PLUSPAK with other GE Healthcare contrast media products, said Dr Mark Hibberd, Chief Medical Officer for GE Healthcares Pharmaceutical Diagnostics unit.
  • Clariscan is available in single dose vials of 10, 15 and 20 mL and now 100 mL Pharmacy Bulk Package in an innovative +PLUSPAK polymer bottle.

GE Healthcare Announces U.S. FDA Approval of Macrocyclic MRI Contrast Agent Clariscan™ (gadoterate meglumine) Injection for Intravenous Use

Retrieved on: 
Monday, November 4, 2019
FDA, Pharmaceutical, Health, Physical sciences, Chemistry, Materials, Medical physics, GE Healthcare, Radiopharmaceuticals, MRI contrast agent, Gadolinium, General Electric, Gadoteric acid, Medical imaging, Magnetic resonance imaging

The U.S. Food and Drug Administration (FDA) has approved Clariscan, a macrocyclic, ionic, gadolinium-based, MRI contrast agent, expanding the GE Healthcare portfolio for U.S. patients and radiologists.

Key Points: 
  • The U.S. Food and Drug Administration (FDA) has approved Clariscan, a macrocyclic, ionic, gadolinium-based, MRI contrast agent, expanding the GE Healthcare portfolio for U.S. patients and radiologists.
  • GE Healthcare offers diagnostic imaging agents used in approximately 90 million procedures per year globally, equivalent to three patients every second.
  • As with all GE Healthcare contrast media products, all stages of manufacturing, from development of the active pharmaceutical ingredient (API) to finished product, are managed entirely by GE Healthcare.
  • GE Healthcare is the $19.8 billion healthcare business of GE (NYSE: GE).