FDA Clears First Neonatal MRI Device for NICUs

Jul 20, 2017

The U.S. FDA cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICUs).

The Embrace Neonatal MRI System is designed for imaging of the neonatal head. It may be used on neonates with a head circumference up to 38 centimeters and weight between 1 and 4.5 kilograms. The system has a temperature-controlled incubator placed directly into the MRI system, minimizing movement of the baby. If urgent access to the baby is necessary during the imaging process, the baby can typically be removed from the system in less than 30 seconds.

The Embrace Neonatal MRI System can be placed inside a NICU environment because the system does not require a safety zone or a radiofrequency shielded room. Since the system is fully enclosed, medical device implants in close proximity to the system are not required to be “MR Conditional” or “MR Safe.”

The FDA granted clearance of Embrace Neonatal MRI System to Aspect Imaging Ltd.

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