Aspect Imaging is Granted FDA Clearance for Neonatal MRI System

Israel-based Aspect Imaging’s Embrace Neonatal MRI has received Food and Drug Administration clearance. The system is purposely designed for neonatal brain and head imaging, so that infants can avoid transportation outside of the neonatal intensive care unit (NICU).

The Embrace Neonatal MRI touts several benefits and safety measures, including the option to allow parents to be present while the procedure is taking place. The scanning lasts less than an hour, and the device doesn’t need a designated safety zone or RF-shielded room; it can be conveniently stored in the NICU. In case of emergency, the baby can be removed from the system in under 30 seconds. According to a press release, the system’s operating and maintenance costs are significantly lower than traditional superconductor MRIs, as the Embrace has minimal power consumption and doesn’t depend on a cooling system. The system is completely enclosed and, therefore, non-MR safe device implants are safe to share the immediate space.

“The vision of Aspect Imaging is to bring clinical diagnostic information to where it is needed the most, and to help neonatologists with their diagnostic decisions. It is now possible to routinely scan premature babies in the NICU, almost immediately after birth, helping to increase the quality of life and improve care for newborns, by assisting in the early detection of health issues, enabling at-risk babies to grow into healthy children,” explained Uri Rapoport, CEO and Founder of Aspect imaging in the company’s press release.