FDA Grants Approval For First-Ever Neonatal MRI Device
Aspect Imaging is happy to announce that the U.S. Food and Drugs Administration has granted its Embrace Neonatal magnetic resonance imaging device clearance for commercial and medical use inside hospital neonatal intensive care units.
The Embrace Neonatal MRI System is designed specifically for head and brain imaging for babies and has passed standards despite a non-clinical testing. However, its 510(k) clearance means that the approved device is already substantially equivalent to a commercially available, legally marketed device.
Embrace MRI is also deemed safe enough to be placed inside the NICU so babies don't need to be taken to MRI suites since doing so could present health risks for the already frail baby.
"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," Vasum Peiris, M.D., M.P.H. explained. Dr. Peiris is FDA's chief medical officer for pediatrics and special populations at the Center for Devices and Radiological Health.
How Safe Is Embrace MRI?
According to the FDA, the neonatal MRI system was assessed for its performance as well as mechanical and technical safety. The agency has also deemed the fully enclosed MRI system safe enough that it does not even require a safety zone, which is why the full system can be placed with vulnerable babies in the NICU.
The system is equipped with a temperature-controlled incubator to minimize the baby's movement while the device is in the middle of a scan. Embrace was also designed to allow the technician to remove the baby from inside the MRI in 30 seconds or less in case of an emergency so that proper care can be given with little delay.
Limitations Of Embrace MRI
According to the FDA and Aspect Imaging, the neonatal MRI can only accommodate babies weighing between 1 and 4.5 kg (2.2 to 9.9 pounds) and with a head circumference of up to 38 cm.
Embrace should also not be used on babies with metallic and/or electronically active implants in order to avoid causing the implant to malfunction or the tissue surrounding it to heat up.
As mentioned above, the neonatal MRI system was approved based on non-clinical testing, which means clearance was achieved by demonstrating the device's effectiveness using infant brain simulations that were approved by an independent board-certified radiologist as being of sufficient quality for diagnostic use.
Watch Aspect Imaging's video below to know more about the Embrace Neonatal MRI system.