Embrace™ Neonatal MRI Device Gains FDA Clearance

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 imaging

According 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.

Robert Hilton
Dr. Robert J. Hilton is an associate in our San Diego office. Dr. Hilton's practice focuses primarily on patent prosecution in the chemistry and life sciences fields. Dr. Hilton earned his J.D. at the J. Reuben Clark Law School at Brigham Young University. While in law school, Dr. Hilton was the president of the Student Intellectual Property Law Association. Dr. Hilton worked at the University Technology Transfer Office during law school, where he gained experience with patent protection and technology licensing. Prior to attending law school, Dr. Hilton earned his Ph.D. in biochemistry. Dr. Hilton's research involved the studies of metals in biological systems. This work required an in depth understanding and training in a variety of chemistry biochemisty techniques such as electron microscopy, ICP-MS, PCR, cell culture, protein purification, and gel electrophoresis. Dr. Hilton was a summer associate for the firm in 2013, and joined the firm in 2014.
Click here to read full bio
View all posts published by Robert Hilton »

Leave a Reply

By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.