FDAnews Device Daily Bulletin

FDA Clears First Neonatal MRI Device

July 25, 2017

The FDA has approved the first MRI device specifically for use in neonatal intensive care units.

While the option to use traditional MRI scanners for neonatal patients already existed, transporting babies from NICUs to other parts of the hospital posed major safety risks and challenges, according to CDRH. Aspect Imaging’s Embrace Neonatal MRI System avoids this issue, and was designed specifically to conduct imaging on infant heads.

The device does not require a safety zone or radiofrequency shielded room, so it can be placed into a NICU without requiring that all medical device implants in the vicinity are “MR Conditional” or “MR Safe.”

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