To better tend babies in the nation’s neonatal intensive care units, the first magnetic resonance imaging (MRI) device designed for newborns recently garnered U.S. Food and Drug Administration approval following thorough safety confirmation.
“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,” Dr. Vasum Peiris, chief medical officer for pediatrics and special populations at FDA’s Center for Devices and Radiological Health, said. “Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population.”
The FDA performed a premarket clearance before approving clearance of the product to Aspect Imaging Ltd., a high-performance MRI system manufacturer headquartered in Toronto. Premarket clearance is a before-market submission intended to show that the equipment is comparable to an existing “predicate” or already marketed device.
“The Embrace Neonatal MRI System is designed specifically for imaging of the neonatal head,” FDA officials said. The device can be used with neonates with a head circumference of up to 38 centimeters and weight of 1 to 4.5 kilograms. It includes a temperature-controlled incubator to keep babies’ movements feasible; and infants can be retrieved from the apparatus within 30 seconds.