The Food and Drug Administration on Thursday approved Aspect Imaging's MRI device for infants in the neonatal intensive care unit.
The Embrace Neonatal MRI System, which is specially designed for imaging newborn babies' heads, contains a temperature controlled incubator in the MRI machine to minimize an infant's movement.
The imaging system does not require a safety zone or radiofrequency shielded room, meaning the technology can be housed within a NICU.
"Although we can use traditional MRI scanners to image neonates, taking babies outside of the neonatal intensive care unit to MRI suites presents great challenges," said Vasum Peiris, MD, MPH, CMO of pediatrics and special populations at FDA's Center for Devices and Radiological Health. "Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population."
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