FDA Clears First MRI System for Neonatal Brain Imaging
The FDA cleared the Embrace Neonatal MRI System, the first of its of its king specifically for neonatal brain and head imaging in neonatal intensive care units (NICU). 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 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. To avoid putting vulnerable patients at risk, the efficacy of the Embrace Neonatal MRI 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 Neonatal MRI System was demonstrated through performance testing, including a review of electrical and mechanical safety measures.