The FDA has approved Bracco’s gadopiclenol-based contrast agent, Vueway, for IV MRI imaging in neonates and infants.
Vueway is a macrocyclic gadolinium-based contrast agent that delivers effective image enhancement at half the gadolinium dose used in other approved macrocyclic agents, according to a Feb. 23 news release. The approval follows pediatric data from a non-randomized clinical trial and marks an extension from the product’s original 2022 FDA approval for adults and children ages 2 and older.
The expanded label provides clinicians with a low-dose contrast option for the youngest patients, a population especially vulnerable to cumulative exposure. Pediatric radiology leaders said the approval supports safer diagnostic imaging without compromising quality.
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