Neonatal MRI Medical Device Approved by the FDA

Medical device maker Aspect Imaging has received US Food and Drug Administration (FDA) approval for its Embrace Neonatal MRI System. The imaging device is the first of its kind to be developed specifically for pediatric patients.

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

The MRI can be a useful tool in the diagnosis of many conditions in pediatric patients, including brain tumors, spinal cord abnormalities and multiple sclerosis. Strong magnetic fields and radio waves are used to generate detailed images of the body.

Aspect Imaging’s Embrace Neonatal MRI System incorporates a special temperature-controlled incubator which helps the technician capture images of the head with minimal movement from the baby. The imaging device can accommodate infants with a head circumference of up to 38 centimeters and a weight up to 4.5 kilograms.

Importantly, the medical device can be installed directly into the neonatal intensive care unit (NICU) to remove the need to transport the patient to a remote imaging site and reduce the risks to the baby. In the case of an emergency, it’s also easier to remove the neonate from the specialized imaging device as compared to an MRI system designed for an adult, taking less than 30 seconds.

Since the pediatric patient population for which the Embrace Neonatal MRI System was developed are so vulnerable, they were not included in trials of the device. Instead, phantoms – objects designed to mimic the baby’s brain – were used to assess the image quality of the device.

While the safety of the medical device was evaluated using both electrical and mechanical measures, the Embrace Neonatal MRI System is not indicated for all pediatric patients. Because the device emits a strong magnetic field, babies with metallic or electronic implants should not be exposed the MRI device.