News | Contrast Media | November 04, 2019

The MRI contrast agent Clariscan (gadoterate meglumine) is now FDA approved for injection for intravenous use

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

November 4, 2019 – The U.S. Food and Drug Administration (FDA) has approved Clariscan, a macrocyclic, ionic, gadolinium-based, magnetic resonance imaging (MRI) contrast agent, expanding the GE Healthcare portfolio for U.S. patients and radiologists. Clariscan is a gadolinium-based contrast agent indicated for intravenous use with MRI in brain (intracranial), spine and associated tissues in adult and pediatric patients to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Clariscan has been approved in more than 55 countries globally and has had more than four million patient doses shipped in those countries. It is the latest in a growing range of imaging agents available in the U.S. from GE Healthcare. For more than 40 years, GE agents have been routinely used across MRI, X-ray/ computed tomography (CT) and ultrasound to enhance the image and support diagnosis.

“Demand for contrast media has significantly increased over the past decade. The introduction of Clariscan increases our clinical offering for U.S. radiologists, enhancing visualization to provide better patient care. Our customers rely on our high-quality products, first-rate supply network, and surrounding services to support their day-to-day work,” explained Kevin O’Neill, president and CEO Pharmaceutical Diagnostics at GE Healthcare.

“The FDA’s approval of this macrocyclic MR agent adds to the range of contrast media options available here in the U.S. and as radiologists we welcome this broader choice,” said Lawrence N Tanenbaum, M.D., FACR

GE Healthcare offers diagnostic imaging agents used in approximately 90 million procedures per year globally, equivalent to three patients every second. In the U.S., GE Healthcare has a strong record of innovation in new contrast media products and indications, with recent FDA approvals for Omnipaque (iohexol) in CT of the abdomen and for Visipaque (iodixanol) in coronary CT angiography. GE Healthcare has invested $240 million in its global manufacturing and supply network over the past five years to deliver imaging agents to hospitals and pharmacies globally.

Clariscan is manufactured in Norway using a proprietary manufacturing process. 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. Clariscan is available in single dose vials of 10, 15 and 20 mL. The packaging contains a 2D data matrix (barcode) on every Clariscan pack, which conveys key information, including national drug code number, individual lot number, and expiration date. This information can be easily scanned and uploaded onto electronic medical systems, helping to reduce the risk of manual data entry errors and helping workflow efficiencies at medical centers. 

For more information: https://corporate.gehealthcare.com/ 

Related content:

VIDEO: Managing Gadolinium Safety

Strategies to Lower CT Contrast Dose and Track Usage

Nurse Injured in MRI Accident at Swedish Hospital

Indian Man Killed in MRI Accident


Related Content

News | Radiology Business

May 29, 2024 — Strategic Radiology added a third California member to the nation’s leading coalition of independent ...

Time May 29, 2024
arrow
News | Lung Imaging

May 24, 2024 — Smokers who have small abnormalities on their CT scans that grow over time have a greater likelihood of ...

Time May 24, 2024
arrow
News | Artificial Intelligence

May 22, 2024 — Lunit, a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, recently ...

Time May 22, 2024
arrow
News | Artificial Intelligence

May 21, 2024 — According to a newly-published study of nearly 5,000 screening mammograms interpreted by an FDA-approved ...

Time May 21, 2024
arrow
News | Oncology Information Management Systems (OIMS)

May 21, 2024 — RaySearch Laboratories AB announced that the oncology information system RayCare* 2024A has been ...

Time May 21, 2024
arrow
News | Proton Therapy

May 21, 2024 — IBA, a world leader in particle accelerator technology, announced that it has signed a contract with the ...

Time May 21, 2024
arrow
News | Point-of-Care Ultrasound (POCUS)

May 20, 2024 — Exo (pronounced “echo”), a medical imaging software and devices company, announced the release of Exo ...

Time May 20, 2024
arrow
News | Radiology Business

May 20, 2024 — Associated Medical Professionals of NY (A.M.P.) announced that internationally recognized radiation ...

Time May 20, 2024
arrow
News | Cardiac Imaging

May 17, 2024 — The Cum Laude Award-Winning Online Poster presented during the 124th ARRS Annual Meeting found that the ...

Time May 17, 2024
arrow
News | Radiology Business

May 14, 2024 — University Hospitals (UH) and Siemens Healthineers announce a 10-year strategic alliance that builds on ...

Time May 14, 2024
arrow
Subscribe Now