FDA clears first neonatal MRI device

The FDA recently granted 510(k) clearance to the first MRI device specifically designed for imaging the neonatal brain and head in the neonatal ICU.

“Although we can use traditional MRI scanners to image neonates, taking babies outside the NICU to MRI suites presents great challenges,” Vasum Peiris, MD, MPH, chief medical officer for pediatrics and special populations at the FDA Center for Devices and Radiological Health, said in the release. “Having a system in the NICU enables safer imaging for this vulnerable patient population.”

The Embrace Neonatal MRI System (Aspect Imaging Ltd.) is designed for infants with a head circumference of 38 cm or less and weighing between 1 and 4.5 kg. This device includes a temperature controlled incubator to prevent movement; in the event of an emergency during the imaging process, the infant can be removed from the system in 30 seconds or less.

The system can be placed inside the NICU without requiring a safety zone or radiofrequency shielded room, and, as the system is fully enclosed, medical device implants near the system are not required to be ‘MR Conditional’ or ‘MR Safe.’

To avoid putting vulnerable neonates at risk, the FDA based its clearance on non-clinical testing – including images of phantoms simulating an infant brain – determined to be of appropriate quality for diagnostic use by an independent board-certified radiologist. The FDA noted that the safety of the system was assessed through performance testing, including a review of electrical and mechanical safety measures. — by Katherine Bortz