FDA clears first MRI device for newborns

Baby picture
Aspect Imaging's neonatal MRI device includes an incubator that is placed directly into the machine, which minimizes the baby's movement.

Aspect Imaging has earned an FDA nod for its neonatal magnetic resonance imaging (MRI) device, designed for head and brain imaging in neonatal intensive care units.

While MRI scanners may be used to image newborns, transporting babies out of the NICU to the MRI can put them at risk, said Vasum Peiris, M.D., chief medical officer for the pediatrics and special populations at the FDA's Center for Devices and Radiological Health, in a statement. "Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population."

Unlike a traditional MRI, the Embrace Neonatal MRI system does not need a radiofrequency shielded room or a safety zone, so it can be placed in the NICU. It also incorporates a temperature-controlled incubator that is placed directly into the machine to minimize the infant's movement.

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The Embrace system may be used to image newborns with a head circumference up to 38 centimeters and who weigh between 1 and 4.5 kilograms. It should not be used in infants weighing more than 4.5 kilograms, or who have metallic or electronic implants as the MRI may cause them to malfunction or heat up.

In April, Aspect Imaging reeled in $30 million to finish developing the Embrace system and to continue working on its stroke-dedicated MRI system. The latter device is designed for the emergency room so that patients may undergo imaging upon arrival instead of being sent to another part of the hospital. The company aims to launch it in 2019.