Med Device Monday: The First Neonatal MRI

This week, FDA announced their clearance of the first magnetic resonance imaging (MRI) device for neonatal patients.

MRI is a diagnostic method used in radiology to make various pictures of the internal structures and organs of the body. Until MRI was approved for neonatal care, babies in neonatal intensive care units (NICUs) had to be taken out of the unit and brought to a traditional MRI suite, creating a variety of challenges and complications for this vulnerable population.

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Exposure outside the unit to various illnesses and even the act of moving a very fragile newborn made getting these valuable (and even lifesaving) images problematic, to say the least. Further, traditional MRI units aren't designed for fragile newborns. 

The Embrace Neonatal MRI machine is designed specifically for infants. The child is placed in a temperature-controlled incubator which then is positioned in the machine. If quick access is needed, the baby can typically be accessed in about 30 seconds.

Check it out:

According to FDA's press release, the machine is designed "specifically for imaging of the neonatal head. The Embrace Neonatal MRI System may be used on neonates with a head circumference up to 38 centimeters and weight between 1 and 4.5 kilograms....The Embrace Neonatal MRI System is contraindicated for patients weighing more than 4.5 kilograms or with a head circumference of more than 38 centimeters. It is also contraindicated for all infants with metallic or electronically active implants since the MRI may cause tissue near the implant to heat or the implant to malfunction." Tiny babies! In these cases, MRI could be used to look for brain damage, hemorrhage, cranial abnormalities, etc. 

Healthcare for children and newborns is certainly more comprehensive than simply miniaturizing the adult version! But, in this case, it seems to have worked. I'm glad to see a device like this cleared, as I imagine it will be life-changing indeed.



Further Reading:

Clearance database entry

More info on pediatric devices

FDA's press release