First magnetic resonance imaging device authorised for U.S neonates

The U.S Food and Drug Administration (FDA) has cleared Embrace Neonatal Magnetic Resonance Imaging (MRI) system for scanning the neonatal head.

An MRI is a medical scan that uses strong magnetic fields and radio waves (radiofrequency energy) to produces detailed images of the internal structures of the body. It can be used to examine almost any part of the body (e.g. brain, spinal cord, joints, bones, breasts, heart and blood vessels, liver, womb, etc.), with the results useful in diagnosing health conditions, planning treatments and assessing how effective previous treatment has been.

The Embrace Neonatal Magnetic Resonance Imaging System is the first MRI device for scanning neonatal brain and head in neonatal intensive care units (NICU). It has a temperature-controlled incubator placed directly into the MRI system, minimising movement of the baby. If access to the baby is urgently necessary during the imaging process, the baby can quickly be removed from the system in less than 30 seconds.

The Embrace Neonatal MRI system is indicated for neonates with a head circumference up to 38 centimetres and weight between 1 and 4.5 kilograms and contraindicated for infants weighing more than 4.5 kilograms or with a head circumference of more than 38 centimetres. The system cannot be used in infants with metallic or electronically active implants because the MRI may cause tissue near the implant to heat or the implant to malfunction.

The clearance of the Embrace Neonatal MRI system was granted to Aspect Imaging Ltd through the premarket clearance (510(k)) pathway.

The efficacy of the System was based on nonclinical 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. While the safety was demonstrated through performance testing, including a review of electrical and mechanical safety measures.

For more details on the clearance, click Embrace Neonatal MRI system


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