Aspect Imaging's neonatal MRI device gains FDA clearance
Aspect Imaging has secured 510(k) clearance for the commercialisation of its neonatal brain and head magnetic resonance imaging (MRI) device from the US Food and Drug Administration (FDA).
Developed for infants with up to 38cm of head circumference and a 1kg-4.5kg weight, the Embrace Neonatal MRI System features a temperature-controlled incubator to reduce the baby’s movement.
The MRI device is said to be designed to deliver a baby within 30 seconds in case of an emergency.
FDA Centre for Devices and Radiological Health pediatrics and special populations chief medical officer Vasum Peiris said: “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.
"Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population."
As the system does not require a safety zone or a radiofrequency shielded room, it can be used in neonatal intensive care units (NICU), while its fully enclosed design eliminates the need for only MR Conditional or MR Safe medical device implants.
Embrace Neonatal MRI’s safety was validated using performance tests, as well as the review of electrical and mechanical safety measures.
In addition, the efficacy of the device to simulate an infant's brain was non-clinically tested using phantom images that were determined sufficient for diagnostic use by an independent board-certified radiologist.
Aspect Imaging develops affordable and user-friendly MR imaging and NMR systems for application in preclinical, medical, and advanced industrial sectors.