On July 20, the FDA cleared the first MRI device specifically for neonatal brain and head imaging in neonatal intensive care units (NICUs).
"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, MD, MPH, CMO for pediatrics and special populations at the 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 is designed specifically for imaging of the neonatal head. It may be used on neonates with a head circumference up to 38 cm and weight between 1 kg and 4.5 kg. The system has a temperature-controlled incubator placed directly into the MRI system, minimizing 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.
The system can be placed inside a NICU environment because the system does not require a safety zone or a radiofrequency-shielded room. Since it 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 nonclinical 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. Safety was demonstrated through performance testing, including a review of electrical and mechanical safety measures.
The Embrace Neonatal MRI System is contraindicated for patients weighing more than 4.5 kg or with a head circumference of more than 38 cm. 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 system was reviewed through the premarket clearance 510(k) pathway. A 510(k) is a premarket submission made to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. The FDA granted clearance of Embrace Neonatal MRI System to Aspect Imaging Ltd.