FDA Clears First MRI Meant for Use in NICUs

Regulatory News

The US Food and Drug Administration (FDA) on Thursday announced it has cleared the first magnetic resonance imaging (MRI) device intended to be used on newborns in neonatal intensive care units (NICUs).

FDA says the device, Aspect Imaging's Embrace Neonatal MRI System, was cleared via the 510(k) pathway specifically for taking images of newborn's heads, and can be used on newborns whose heads measure up to 38 centimeters in circumference and weigh between 1 and 4.5 kilograms.

According to FDA, the decision to clear the device was based on non-clinical testing using phantom images simulating an infant brain and safety data from performance testing and a review of the device's "electrical and mechanical safety measures."

"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, chief medical officer for pediatrics and special populations at the Center for Devices and Radiological Health, adding that "having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population.

The device also includes a temperature-controlled incubator to minimize the baby's movement during the scan, and FDA says that a baby "can typically be removed from the system in less than 30 seconds" if urgent access to the baby is required.

Because the system is fully enclosed, FDA says it does not require a safety zone or a radiofrequency shielded room, and can safely be used near patients with medical implants that are not labeled "MR Conditional" or "MR Safe".

However, the Embrace system is contraindicated for use in patients with metal or electronic implants, as FDA says the device "may cause tissue near the implant to heat or the implant to malfunction."

FDA