Innovative MRI Device Images Neonatal Head

The system can be placed inside a neonatal intensive care unit (NICU) environment, since it does not require a safety zone or a radiofrequency (RF) shielded room. And since the system is fully enclosed, medical device implants in close proximity to the system are not required to be "MR Conditional" or "MR Safe."

System features include a simplified workflow to allow prep and scan in less than an hour; a dedicated head coil that enables diagnostic quality brain imaging; continuous monitoring of the infant’s vital signs parameters during scan; a 5-Gauss line within the magnet covers, allowing select NICU equipment to be placed near the system; three size swaddles to reduce infant movement and allow routing of tubing and monitoring leads; a non-cryogenic technology that does not require a cooling system; and PACS/HIS/RIS connectivity with DICOM compatibility. The system is contraindicated for all infants with metallic or electronically active implants.

“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 the pediatrics and special populations at the FDA Center for Devices and Radiological Health (CDRH). “Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population.”

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