FDA clears first NICU-friendly neonatal MRI system
The FDA has cleared an MRI system for head and brain imaging in neonatal intensive care units (NICUs).
The agency announced Thursday that Aspect Imaging’s Embrace Neonatal MRI system proved safe and efficacious in testing that included phantom image review by an independent board-certified radiologist.
FDA says the system, the first neonatal MRI to prove NICU-ready, uses a temperature-controlled incubator and enables removal of the baby from the scanner in fewer than 30 seconds in case of emergency.
Further, the Embrace system does not require a safety zone or a radiofrequency shielded room. The system is fully enclosed, allowing its use near people with medical implants that are not designated as MR-safe or -compatible, according to the announcement.
“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,” says Vasum Peiris, MD, MPH, chief medical officer for pediatrics and special populations at FDA’s Center for Devices and Radiological Health, in prepared remarks. “Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population.”
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.