Aspect Imaging has secured approval from the US Food and Drug Administration (FDA) for its Embrace Neonatal magnetic resonance imaging (MRI) device, which it claimed to be the first MRI device specifically designed for neonatal brain and head imaging.
The Embrace Neonatal MRI system is designed for imaging neonatal heads, and may be used on nenonates with a head circumference of up to 38 cm and a weight between 1 and 4.5 kg.
The system features a temperature-controlled incubator which can be placed directly into the MRI system to reduce movement.
The system allows for urgent access to the neonates if required, with the baby typically able to be removed from the system in less than 30 seconds.
Aspect Imaging’s system is designed to be placed inside an NICU environment and does not require that devices or implants in close proximity be MR Conditional or MR Safe as the system is fully enclosed and shielded, the FDA said.
The system’s efficacy was demonstrated primarily depending on non-clinical testing including images of phantoms simulating an infant brain that were verified to be of adequate quality for diagnostic use by an independent board-certified radiologist.
Its safety was demonstrated by performance testing, including a review of electrical and mechanical safety measures.
FDA’s Center for Devices and Radiological Health chief medical officer for pediatrics and special populations 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.”
In April this year, Aspect Imaging raised $30m to support the development of its Embrace system and a new, stroke-dedicated MRI system.
Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.