Technology | Pediatric Imaging | July 21, 2017

FDA Clears First Neonatal Magnetic Resonance Imaging Device

Embrace Neonatal MRI System indicated for neonates with head circumference less than 38 centimeters, weight between 1 and 4.5 kilograms

July 21, 2017 — The U.S. Food and Drug Administration (FDA) has cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU).

“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,” said Vasum Peiris, M.D., M.P.H., chief medical officer for pediatrics and special populations at 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 Neonatal MRI System from Aspect Imaging is designed specifically for imaging of the neonatal head. The system may be used on neonates with a head circumference up to 38 centimeters and weight between 1 and 4.5 kilograms. It has a temperature-controlled incubator placed directly into the MRI system, minimizing movement of the baby. If urgent access to the baby is necessary during the imaging process, the baby can typically be removed from the system in less than 30 seconds.

The Embrace Neonatal MRI System can be placed inside a NICU environment because the system does not require a safety zone or a radiofrequency shielded room. Since the system is fully enclosed, medical device implants in close proximity to the system are not required to be MR-conditional or MR-safe.

To avoid putting vulnerable patients at risk, the efficacy of the system was demonstrated primarily based on non-clinical testing, including images of phantoms simulating an infant brain that were determined to be of sufficient quality for diagnostic use by an independent board-certified radiologist. The safety of the Embrace Neonatal MRI System was demonstrated through performance testing, including a review of electrical and mechanical safety measures.

The system is contraindicated for patients weighing more than 4.5 kilograms or with a head circumference of more than 38 centimeters. It is also contraindicated for all infants with metallic or electronically active implants since the MRI may cause tissue near the implant to heat or the implant to malfunction.

The Embrace Neonatal MRI System was reviewed through the premarket clearance (510(k)) pathway. A 510(k) is a premarket submission made to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

The FDA granted clearance of Embrace Neonatal MRI System to Aspect Imaging Ltd.

For more information: www.aspectimaging.com

Related Content

A brain MRI. Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns.
Feature | Magnetic Resonance Imaging (MRI) | February 16, 2018 | Dave Fornell
One of the biggest concerns in radiology in recent years is the safety of gadolinium-based contrast agents (GBCAs) us
Arterys Receives First FDA Clearance for Oncology Imaging Suite With Deep Learning
Technology | Artificial Intelligence | February 15, 2018
February 15, 2018 — Arterys Inc. announced its fifth 510(k) clearance from the U.S.
AHRA and Canon Medical Systems Announce 2017 Putting Patients First Grant Winners
News | Patient Engagement | February 14, 2018
The Association for Medical Imaging Management (AHRA) and Canon Medical Systems recently announced the tenth annual...
Videos | Pediatric Imaging | February 14, 2018
ITN Associate Editor Jeff Zagoudis demonstrates several mobile apps designed to help pediatric patients learn what an
Vantage Galan 3T XGO Edition MRI system was cleared by the FDA.
Technology | Magnetic Resonance Imaging (MRI) | February 12, 2018
February 12, 2018 — Physicians now have access to more neuro and cardiac...
MedyMatch Receives FDA Device Designation for Intracranial Hemorrhage Software
News | Computed Tomography (CT) | February 01, 2018
February 1, 2018 – MedyMatch Technology, a company focused on helping physicians provide accurate patient assessment
Machine Learning Techniques Generate Clinical Labels of Medical Scans
News | Artificial Intelligence | January 31, 2018
Researchers used machine learning techniques, including natural language processing algorithms, to identify clinical...
Indian Man Killed in MRI Accident. MRI magnet safety is key, the magnet is always on.
News | Magnetic Resonance Imaging (MRI) | January 30, 2018 | Jeff Zagoudis, Associate Editor
Investigations are underway at a hospital in Mumbai, India, after a man was killed when he was sucked into a magnetic...
Bracco Diagnostics' MultiHance Contrast Agent Earns Expanded Approval for Pediatric MRI
News | Contrast Media | January 30, 2018
Bracco Diagnostics Inc. announced the labeling of its contrast agent MultiHance has obtained U.S. Food and Drug...
FDA Releases New Guidance on Children's X-ray Exams
Feature | Pediatric Imaging | January 26, 2018
Most people have had an X-ray taken at some time during their lives — perhaps checking for a possible broken bone or...
Overlay Init