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FDA approves Bayer’s Ambelvist contrast agent
The US FDA has approved Bayer’s Ambelvist, a mGBCA, for use in MRI in adults and children, including term neonates. The approval is based on global Phase III QUANTI studies evaluating Ambelvist's efficacy and safety in adults and children. The studies showed increased lesion visualisation using pre-contrast and post-contrast MRI with reduced gadolinium dose. Credit: Gorodenkoff / Shutterstock.com. The US Food and Drug Administration (FDA) has approved Bayer’s Ambelvist (gadoquatrane), a macrocyclic gadolinium-based contrast agent (mGBCA), for use in magnetic resonance imaging (MRI) in adults and children, including term neonates. The agent is indicated for identifying and visualising lesions with…
The US FDA has approved Bayer’s Ambelvist, a mGBCA, for use in MRI in adults and children, including term neonates.
Source: Medical Device Network