Israel-based Aspect Imaging has obtained CE-Mark for its Embrace Neonatal MRI System designed to prepare and scan newborns inside the Neonatal Intensive Care Unit (NICU).
Embrace is intended to minimise the time and risks associated with moving the infants to an external facility where conventional MRI scanners are usually present.
The new system can be placed in the NICU as it does not require a special safety zone or an RF-shielded room.
Designed for babies weighing between 1kg and 4.5kg, the system can even be used to scan intubated infants without the need for disconnection and reconnection of the tubing.
Aspect Imaging founder and CEO Uri Rapoport said: “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.
“Our technology will be able to assist neonatologists with their clinical diagnoses in the NICU, and improve neonatal care where it will be used.”
Embrace Neonatal MRI System, which takes less than one hour to prepare and scan, features a permanent magnet that eliminates the need for electrical, cryogenic or water cooling.
The system also includes the firm’s magnet technology to minimise power consumption, along with operating and maintenance costs.
An integrated, temperature-controlled incubator-like patient bed is also incorporated into the system to decrease the infant’s movement.
With the US Food and Drug Administration (FDA) clearance received in July, the Embrace system is currently being used at Shaare Zedek Medical Centre in Jerusalem, Israel.