WASHINGTON, July 20 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Thursday approved the first magnetic resonance imaging (MRI) device specifically designed to scan neonatal brains and heads in intensive care units.
"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," Vasum Peiris, chief medical officer for pediatrics and special populations at FDA's Center for Devices and Radiological Health, said in a statement.
"Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population," Peiris said.
The FDA explained that the new device, known as Embrace Neonatal MRI System, is fully enclosed and does not require a safety zone or a radiofrequency shielded room.
As a result, it can be placed inside a neonatal intensive care unit environment and medical device implants in close proximity to the system are not required to be "MR Conditional" or "MR Safe," it said.
The system, developed by Israel-based Aspect Imaging Ltd., may be used on neonates with a head circumference up to 38 centimeters and weight between 1 and 4.5 kilograms.
It is contraindicated for patients weighing more than 4.5 kilograms or with a head circumference of more than 38 centimeters, the FDA added.
