- The U.S. Food and
Drug Administration cleared the first magnetic resonance imaging (MRI)
device to be used on neonates
- Called the
Embrace Neonatal MRI System, it is designed specifically for neonatal head
and brain imaging
- This device can
be placed inside the premises of neonatal intensive care units
The U.S. Food and Drug
Administration cleared the first magnetic resonance imaging (MRI) device called
the Embrace Neonatal MRI System
that can be used on newborns or
neonates. The device is specifically going to be used for neonatal brain and
head imaging in neonatal intensive care units (NICU).
The neonatal period refers to the first four weeks of the child
after birth. It is a very critical period when important events like bonding
with parents and feeding patterns are established. Chances of infections that
could indicate serious conditions, and congenital defects surface during this
period. Hence, a safe and effective imaging device that can be used on newborns
to diagnose the precise condition is much needed during this period.
‘US FDA has cleared the first magnetic resonance imaging device to be used for neonates inside neonatal intensive care units thus minimizing chances of any infections that might occur while transporting them to MRI scanner rooms.’
Magnetic Resonance Imaging (MRI) Devices
procedure is a medical
imaging procedure that is useful to diagnose as well as treat an array of
conditions in the body. It uses strong magnetic fields, radio waves (radiofrequency
energy) and a computer to produce detailed pictures of
the internal structures of the body.
waves manipulate the magnetic position of the atoms
(mainly the protons in fat and water molecules in the body). The signals are picked up by a
powerful antenna and sent to a computer. The computer performs millions of
calculations, and produces clear, cross-sectional black and white images of the
body from which three-dimensional (3-D) pictures are drawn of the scanned area.
These pictures are then interpreted by a trained physician who diagnoses the
condition.Uses of an MRI
MRI devices can detect a variety
of conditions including problems of the brain,
spinal cord, chest, lungs, abdomen, pelvis, and limbs. An MRI of the brain in
particular can be used to detect cysts, tumors, bleeding, swelling,
developmental and structural abnormalities, infections, inflammatory
conditions, or problems with the blood vessels. Sometimes it is used to
determine the cause of symptoms like persistent headaches, dizziness, weakness,
and blurry vision or seizures
may bog down the infant.
Advantages and Disadvantages of
MRI is considered
a fairly safe imaging technique with no evidence of serious harm to human
tissue reported even when used on neonates. MRI devices
are the only imaging procedures that provide clinicians and researchers objective,
superior, in vivo information about brain anatomy, pathology and also
functional and physiological characteristics in neonates.
aid in fetal diagnosis, management of a fetus with a
known diagnosis and help to provide additional information in cases where
termination is considered and when there is any uncertainty over the diagnosis.
Some of the general disadvantages
of an MRI are the time
required for preparation, complex scheduling, loud acoustic noise and high
costs. But these can be overlooked because of the safety of an MRI
and the fact that it can provide clear images of the organs that cannot be seen
as well with an X-ray, CAT scan, or ultrasound.
A couple of drawbacks of using the MRI scanner seen particularly in
neonates are the following. These can hopefully be eliminated in the Embrace Neonatal MRI System.
There should be no movement during an MRI as it can cause image
artifact or distortion, prolong the examination and cause a misdiagnosis due to
poor image quality. Since, it is not possible for infants to stay still, they are often
sedated during MRI studies, which prolongs the time of imaging. Sedating agents
could also pose a risk to the infant.
Also, up until now, neonates had to be transported to the rooms that
housed the MRI scanners. This could expose them to infections. So having MRI
scanners inside the premises of NICUs suitable is the need of the hour.
"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."
Embrace Neonatal MRI System
The Embrace Neonatal MRI System is designed specifically for imaging of
the neonatal head.
Some of the features of the Embrace Neonatal MRI System are:
- It may be used on
neonates who have a head circumference up to 38 centimeters and a weight
of anywhere from 1 to 4.5 kilograms.
- It has a
temperature-controlled incubator placed directly into the MRI system that
helps in minimizing movement of the baby. If there is a need to access or
remove the baby urgently during the imaging process, it can be done in
less than 30 seconds.
- It can be placed
directly inside a NICU environment since an MRI system is fully closed,
and hence does not require a safety zone or a radiofrequency shielded room
to protect other medical device implants in close proximity to the system.
There are some contraindications of the Embrace Neonatal MRI System:
- It cannot be used
on patients who weigh more than 4.5 kilograms or who have a head
circumference of more than 38 centimeters
- It cannot be used
on infants with metallic or electronically active implants since it may
heat up the tissue near the implant or cause the implant to
The functionality and quality of the Embrace Neonatal MRI System was
demonstrated on non-clinical testing that included imaging phantoms (objects
used to test imaging devices) that simulated an infant brain; this was done so
as to not put patients at risk. It was then certified for diagnostic use by a
board-certified radiologist. The safety was demonstrated through performance
testing that included a review of electrical and mechanical safety measures.
FDA granted clearance of Embrace Neonatal MRI System to Aspect Imaging Ltd,
a world leader in
design and development of MRI systems.
- FDA clears first neonatal magnetic resonance imaging device - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm567840.htm)
- MRI fo the preterm infant - (http://www.pedrad.org/Portals/5/Events/2013/KlineFathPretermBrain-NEW.pdf)
- Fetal and Neonatal Brain Magnetic Rsonance Imaging - (http://www.bapm.org/publications/documents/guidelines/BAPM%20MRI%20standards%20for%20fetal%20neonatal%20brain%20imaging_FINAL%20SUBMISSION%20080216.pdf)
- Smyser CD, Kidokoro H, Inder TE. MRI of the brain at term equivalent age in extremely premature neonates - to scan or not to scan? Journal of paediatrics and child health. 2012;48(9):794-800. doi:10.1111/j.1440-1754.2012.02535.x.