First Neonatal MRI device approved by FDA

MRISCAN

The US FDA has cleared the first neonatal MRI device for head and brain imaging in NICU the device is known as Embrace Neonatal MRI System. Vasum Peiris, M.D., M.P.H., chief medical officer for pediatrics and special populations at FDA’s Center for Devices and Radiological Health said “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,” he also said that “Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population.”

The New MRI unit can be used on neonates with a head circumference up to 38 cm (15 in) and weighing between 1 and 4. 5 kg (2.2 to 10 lbs). it has a temperature controlled incubator place in the MRI system directly which minimizes the baby movement. As the system is fully enclosed it does not require radio frequency shielded room or safety zone.

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

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