The FDA has just cleared Aspect Imaging‘s Embrace Neonatal MRI System, the first dedicated neonatal MRI system to receive a regulatory green light in the U.S. It’s intended to be used to image the head and brain, and to remain inside of neonatal intensive care units (NICU).
Currently, these fragile little patients have to be moved to a distant MRI machine in the hospital, complicating the process and creating unneeded risks. Having the scanner nearby should help simplify imaging and being inside the NICU already can help address any emergencies that may arise. Because it’s a fully contained system, unlike traditional MRIs it does not require an exclusion zone nor is there a need to have additional walls shielding the radiofrequency signal. As such, MR Conditional and MR Safe implanted devices can be used by anyone in proximity to the scanner. Neonates with metal implants, on the other hand, are contraindicated from being imaged by the Embrace scanner.
The Embrace features a temperature regulated incubator that moves in and out of the scanner with the baby inside. This helps to prevent the child from moving too much during scanning, while allowing clinicians to extricate the child out of the machine in less than 30 seconds if necessary.
The device is indicated for neonates with a head circumference no larger than 38 centimeters and weight between 1 and 4.5 kilograms
Here’s a promo video for the Embrace Neonatal MRI:
Product page: Embrace Neonatal MRI System…
Via: FDA…
