The Embrace Neonatal MRI System, designed by Aspect Imaging, Ltd., is the first MRI device designed specifically for the brain and head imaging of newborns in the NICU. Unlike traditional MRI systems, which require rooms to be shielded, the Embrace system is self-contained, doesn’t affect nearby medical devices or equipment, and does not require a radiofrequency shielded room.
Although traditional MRIs are not unsafe for infants, FDA spokesperson Stephanie Caccomo said in an emailed statement that “taking babies outside of the neonatal intensive care unit to MRI suites is a safety concern.” The FDA granted 501(k) clearance for the system in July.
The Embrace system is specifically designed for newborns between 2.2 and 10 pounds and with a head circumference of up to 15 inches (38 cm). Swaddle systems within a temperature-controlled incubator minimize the movements of the tiny patients and also provides a routing system for monitoring equipment and medical tubing. The setup allows the babies to be removed from the device in less than 30 seconds if there’s an emergency.
Head imaging is often used on infants when doctors suspect bleeding inside the skull (also known as intracranial hemorrhage). This type of injury in a newborn is frequently associated with prolonged deliveries, with breech deliveries, or when the use of forceps or extractors is required.
A 2007 study in the journal Radiology reported that roughly 25 percent of full-term infants had asymptomatic intracranial hemmorage and that babies born prematurely are even more likely to experience this complication than full-term infants. Another study, published in 2008, performed a series of brain imaging and ultrasounds on 101 asymptomatic full-term infants. It found that most of the hemorrhages that were present at birth had resolved by the time the baby was 1 month old and all had resolved by 3 months of age. Infants with symptomatic hemmoraging can experience seizures, bradycardia, apnea and other neurological problems.