FDA Clears Neonatal MRI System

The US Food and Drug Administration (FDA) has approved a magnetic resonance imaging (MRI) system designed specifically to serve neonatal intensive care units (NICUs).

The Embrace Neonatal MRI System (Aspect Imaging) is intended for head and brain imaging for neonates with a head circumference of up to 38 cm and body weight between 1 kg and 4.5 kg. The unit, which can be housed directly inside a NICU environment, includes a temperature-controlled incubator that is placed directly into the MRI system to minimize movement of the patient. The 1.0 Tesla system does not require a safety zone or radiofrequency-shielded room due to its fully enclosed design.

“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 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.”

The efficacy and safety of the MRI system was demonstrated mainly through nonclinical testing, including images of phantoms simulating an infant brain that were of sufficient quality for diagnostic use.

The FDA noted that in the event of an emergency, the patient can be removed from the system in less than 30 seconds. In addition, medical device implants in close proximity to the unit do not need to be “MR conditional” or “MR safe.” The system is contraindicated for infants weighing >4.5 kg, having a head circumference >38 cm, or with metallic or electronically active implants.

Reference

FDA clears first neonatal magnetic resonance imaging device [news release]. FDA newsroom; July 20, 2017.