FDA Clears 3T MRI Device for Neonates and Infants

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Ascent^3T Neonatal Magnetic Resonance Imaging (MRI) System, which has been designed for whole-body imaging of neonates and infants.

Noting that the Ascent3T Neonatal MRI System is the first high-field 3T MRI platform geared to neonate and infant imaging, Eyas Medical Imaging, the developer of the device, said it provides enhanced detail of the heart, brains, lungs and abdomen in this patient population.

The company added that the Ascent^3T Neonatal MRI System was developed at Cincinnati Children’s Hospital Medical Center and incorporates advanced electronics and pulse sequences from Philips.

In addition to a compact design that facilitates installation in neonatal intensive care units (NICUs), the Ascent^3T Neonatal MRI System offers a detachable table that can facilitate patient transfers, according to Eyas Medical Imaging.

“We took great care in the design of the Ascent^3T. Our goal is to transform neonatal care by bringing an unprecedented level of MR imaging and access to the most vulnerable patients when and where they need it,” said MR physicist Charles Dumoulin, Ph.D., a professor of Pediatrics and Radiology at Cincinnati Children’s and the founder of Eyas Medical Imaging.