The US Food and Drug Administration (FDA) has granted 510(k) clearance for the first MRI device designed specifically for brain and head imaging of newborns in the neonatal intensive care unit (NICU).
The Embrace Neonatal MRI System (Aspect Imaging Ltd) can be used on neonates with a head circumference up to 38 cm and weighing between 1 and 4.5 kg.
The system has a temperature-controlled incubator placed directly into the MRI system, minimizing movement of the infant. If urgent access to the newborn is required during imaging, the baby can typically be removed from the system in less than 30 seconds, the FDA explains in a news release.
"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. Having a system in the neonatal intensive care [unit] enables safer imaging for this vulnerable patient population," Vasum Peiris, MD, MPH, chief medical officer for pediatrics and special populations at the FDA's Center for Devices and Radiological Health, said in the release.
The Embrace Neonatal MRI System can be placed inside the NICU because the system does not require a safety zone or a radiofrequency shielded room. The system is fully enclosed, so medical device implants near the system are not required to be "MR Conditional" or "MR Safe."
"To avoid putting vulnerable patients at risk, the efficacy of the Embrace Neonatal MRI System was demonstrated primarily based on non-clinical testing including images of phantoms simulating an infant brain that were determined to be of sufficient quality for diagnostic use by an independent board-certified radiologist," the FDA says. The safety of the system was demonstrated through performance testing, including a review of electrical and mechanical safety measures.
The Embrace Neonatal MRI System should not be used in patients weighing more than 4.5 kg or with a head circumference greater than 38 cm. The system is also contraindicated for all infants with metallic or electronically active implants because the MRI may cause tissue near the implant to heat or the implant to malfunction, the FDA said.