Aspect Imaging earned a CE mark for its neonatal magnetic resonance imaging (MRI) device, which allows for the preparation and imaging of newborns inside the neonatal intensive care unit (NICU).
While regular MRI scanners may be used to image newborns, removing babies from the NICU for scanning can be risky. Unlike traditional MRI machines, the Embrace Neonatal MRI does not need a safety zone or a radiofrequency shielded room, so it may be placed in the NICU.
The system has an integrated, temperature-controlled incubator-like patient bed to minimize the infant's movement during scanning. It is indicated for the imaging of infants weighing from 1 kilogram to 4.5 kilograms, according to a statement.
“Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population,” said Vasum Peiris, M.D., chief medical officer for the pediatrics and special populations at the FDA's Center for Devices and Radiological Health when the system scored FDA clearance in July.
In addition to reducing risk to newborns who need imaging, the Embrace system allows medical staff easier access to infants during scanning. The device’s design also allows intubated infants to be scanned without disconnecting the tubing.
“We’re thrilled to finally have CE marking for our Embrace system, so that we can continue to reach and help the most vulnerable population of all—premature babies,” said Aspect CEO said Uri Rapoport, in the statement. “Our technology will be able to assist neonatologists with their clinical diagnoses in the NICU, and improve neonatal care where it will be used.”