The FDA cleared the first MRI device specifically for neonatal brain and head imaging in neonatal intensive care units.
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Brain imaging

FDA approves first neonatal MRI

The U.S. Food and Drug Administration cleared the first MRI device specifically for neonatal brain and head imaging in neonatal intensive care units.

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.

Vasum Peiris, M.D.

“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, M.D., M.P.H., chief medical officer for 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.”

The Embrace Neonatal MRI System is designed specifically 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 MRI System can be placed inside a NICU environment because the it 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 to Aspect Imaging Ltd.


Source: FDA

21.07.2017

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