Brigham and Women's installs first neonatal MRI in US
Brigham and Women’s Hospital has become the first health center in the U.S. to install an MRI machine for use in its neonatal intensive care unit (NICU).
Installation of the Aspect Imaging scanner aims to help physicians to image the brains of newborns without moving them out of the NICU.
Aspect secured FDA clearance for the scanner last year to cut the risk of generating images that show whether neonates have suffered brain injuries.
The ability of MRI equipment to generate detailed images of soft tissues makes them the scanners of choice for teams caring for people with brain injuries. However, when the person being treated is an infant in their first few weeks of life the question of whether to perform an MRI scan is complicated by certain factors.
As MRI machines are based outside of NICUs, physicians need to move vulnerable newborns across hospitals to perform scans. At the MRI unit, the equipment is ill-suited to the needs of neonates, who are far smaller than most patients, may move about a lot and often require vital sign monitoring.
These characteristics of neonates complicate the task of safely generating high-quality MRI scans in standard equipment. Recognizing that, Aspect developed Embrace. The scanner is designed to be installed in NICUs, eliminating the need to transfer neonates, and has multiple features tailored to the needs of newborns and the teams that care for them. Babies enter the scanner in an incubator bed that controls the temperature, minimizes their movement and monitors their vital signs.
Terrie Inder, chair of the department of pediatric newborn medicine at Brigham and Women's Hospital sees benefits to installing the scanner within the NICU.
"Locating this technology within the NICU will reduce time and patient risk associated with transporting newborns to a traditional MRI and allow MRI access from the first hours of life through the challenging, sometimes life threatening, time within the NICU," Inder said in a statement. The hospital will initially only use the scanner in applied medical research.
Aspect secured 510(k) clearance for Embrace in July 2017 on the strength of a filing that compared it to the company's existing equipment for generating MR images of adult wrists and hands. The two machines differ in multiple ways, from the size of the bore opening to the number of radiofrequency coils, but have more in common with each other than conventional MRI scanners. Both of Aspect's scanners are notably smaller than traditional full-body MRI machines.
Natus Medical is distributing Embrace in the U.S. for Israel-based Aspect.
- Brigham and Women’s BWH Receives First NICU-installed MRI system in U.S. on Sept. 8
- FDA 510(k) Summary