mri baby friendly

Embrace™ Neonatal MRI Device Gains FDA Clearance

According to the news release, the Embrace™ Neonatal MRI gained premarket clearance through a 510(k) submission, demonstrating that the new device is substantially equivalent to a legally marketed predicate device. The Embrace™ system is purported to be a fully enclosed system that does not required a safety zone or a radiofrequency shielded room, and can therefore be placed within the NICU itself.

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