FDA Clears First MRI Device for Neonatal Imaging in NICU

The system does not require a safety zone or a radiofrequency shielded room allowing it to be placed in the NICU
The system does not require a safety zone or a radiofrequency shielded room allowing it to be placed in the NICU

The first magnetic resonance imaging (MRI) device for neonatal brain and head imaging in neonatal intensive care units (NICU) has been cleared by the Food and Drug Administration (FDA).

The Embrace Neonatal MRI System is specifically designed for imaging of the neonatal head (head circumference up to 38cm and weight of 1 – 4.5kg). The system has a temperature-controlled incubator which limits movement, while the baby can be removed in cases of urgency in under 30 seconds.

An independent board-certified radiologist assessed the efficacy of the MRI System via non-clinical testing to avoid putting patients at risk. The test involved images of phantoms simulating an infant brain and were deemed to be of sufficient quality for diagnostic use. 

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The system does not require a safety zone or a radiofrequency shielded room allowing it to be placed inside the NICU area. “Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population," said Vasum Peiris, MD, MPH, CMO for pediatrics and special populations at FDA's Center for Devices and Radiological Health. 

The Embrace Neonatal MRI System is contraindicated for patients weighing >4.5kg or with a head circumference of >38cm. 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.  

For more information visit FDA.gov.