First neonatal magnetic resonance imaging device cleared by US FDA

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

“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,” says Vasum Peiris, chief medical officer for the paediatrics and special populations at FDA’s Center for Devices and Radiological Health. “Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population.”

The Embrace neonatal MRI system (Aspect Imaging) is designed specifically for imaging of the neonatal head. The system may be used on neonates with a head circumference up to 38cm and weight between 1kg and 4.5kg. The system has a temperature-controlled incubator placed directly into the MRI system, minimising movement of the baby. If urgent access to the baby is necessary during the imaging process, the baby can typically be removed from the system in less than 30 seconds.

Embrace can be placed inside a NICU environment because the system does not require a safety zone or a radiofrequency shielded room. 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.”

To avoid putting vulnerable patients at risk, the efficacy of the system was demonstrated primarily based on non-clinical testing including images of phantoms simulating an infant brain that were determined to be of sufficient quality for diagnostic use by an independent board-certified radiologist. The safety of the Embrace system was demonstrated through performance testing, including a review of electrical and mechanical safety measures.

The Embrace system is contraindicated for patients weighing more than 4.5kg or with a head circumference of more than 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.

The Embrace neonatal MRI system was reviewed through the premarket clearance (510(k)) pathway.

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