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GE Healthcare announces U.S. FDA approval of macrocyclic MR contrast agent Clariscan in pre-filled syringes

Press releases may be edited for formatting or style | November 24, 2020 MRI

GE Healthcare’s Pharmaceutical Diagnostics unit develops and supplies imaging agents used to support around 100 million procedures per year globally, equivalent to three patients every second. Clariscan, approved by U.S. FDA in November 2019, is the latest in a growing range of imaging agents available in the U.S. which are used across MRI, X-ray/CT and ultrasound to enhance the image and support diagnosis.

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

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pharmaceutical ingredient (API) to finished product, are managed entirely by GE. Clariscan is available in single dose vials of 10, 15 and 20 mL; 100 mL Pharmacy Bulk Package in +PLUSPAK polymer bottles; and now 10, 15 and 20mL clear plastic pre-filled syringes.


About GE Healthcare:
GE Healthcare is the $16.7 billion healthcare business of GE (NYSE: GE). As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping to drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.

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