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In a June 20 press release, the U.S. Food and Drug Administration (FDA) announced it had cleared the first MRI device designed for neonatal brain and head imaging in intensive care units.

The Embrace Neonatal MRI System from Aspect Imaging can be used on neonates weighing from 2.2 to 9.9 lbs. (1 to 4.5 kg) with a head circumference up to 15 inches (38 centimeters).

“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, chief medical officer for pediatrics and special populations at FDA’s Center for Devices and Radiological Health, in the release. “Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population.”

The Embrace System includes a temperature-controlled incubator that can be place directly into the MRI system, which helps minimize movement for the baby. The system can be placed inside a NICU environment because it does not require a safety zone or a radiofrequency shielded room.