The US Food and Drug Administration (FDA) has approved the first-ever magnetic resonance imaging (MRI) device for neonatal brain and head imaging in neonatal intensive care units. Aspect Imaging’s Embrace Neonatal MRI System is designed specifically for imaging of the neonatal head, and its efficacy was determined through performance testing, rather than clinical means, which could have put vulnerable patients at risk, according to an agency statement. Performance testing included images of phantoms simulating an infant brain that an independent, board-certified radiologist determined to be of sufficient quality for diagnostic purposes. Moreover, the equipment demonstrated proper electrical and mechanical safety. It can be used on neonates with a head circumference of up to 38 centimeters and a weight between 1 and 4.5 kg. The system minimizes baby movement with a temperature-controlled incubator, which is place directly in to the MRI system. Babies can be quickly removed from the incubator in less than 30 seconds if emergency access is necessary. “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 FDA’s Center for Devices and Radiological Health. “Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population.” The Embrace Neonatal MRI System can be placed inside an NICU because it doesn’t require a safety zone or radiofrequency shielded room. Since it’s fully enclosed, medical device implants in close proximity are not required to be MR Conditional or MR Safe, the statement read. The neonatal MRI system was reviewed through the premarket clearance (510(k)) pathway, a premarket submission made to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. Source
