Embrace™ Neonatal MRI Device Gains FDA Clearance

Knobbe Martens

Knobbe Martens

On July 20, 2017, the Food and Drug Administration announced the clearance of “the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU)” to Aspect Imaging Ltd.

Image result for embrace aspect imagingAccording to the news release, the Embrace™ Neonatal MRI gained premarket clearance through a 510(k) submission, demonstrating that the new device is substantially equivalent to a legally marketed predicate device.

The Embrace™ system is purported to be a fully enclosed system that does not required a safety zone or a radiofrequency shielded room, and can therefore be placed within the NICU itself.  

According to Vasum Peirius, chief medical officer for pediatrics and special populations at the FDA’s Center for Devices and Radiological Health,

“Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population.”

The Embrace™ system’s specifications indicate that it can be used on newborn infants from 2 to 10 pounds and having a head circumference of up to 38 centimeters.  According to Aspect Imaging, major applications of Embrace™ include hypoxic-ischemic encephalopathy, periventricular leukomalacia, cerebral infraction, germinal matrix and intraventricular hemorrhage, cerebral hemorrhage, sinus thrombosis, white matter injury, deep gray matter injury, and brain development.

Image result for embrace aspect imagingAspect Imaging Ltd. states on its website that it designs and develops compact magnetic resonance imaging (MRI) and nuclear magnetic resonance (NMR) systems for preclinical, medical, and advanced industrial applications. According to its website, Aspect Imaging has developed compact high-performance permanent magnets that overcome many of the primary drawbacks of traditional MRI systems, including reducing the cost, reducing the complexity, and improving the safety of MRI systems.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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