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# FDA Clears ‘First’ Neonatal MRI System
- URL: https://www.fdaweb.com/fda-clears-first-neonatal-mri-system/
- Published: 2017-07-20T12:00:00.000Z
- Updated: 2026-09-14T22:35:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139184

FDA has cleared an Aspect Imaging 510(k) for the Embrace Neonatal MRI System, which [FDA describes](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm567840.htm?ref=fdaweb.com) as the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units. It has a temperature-controlled incubator placed directly into the MRI system, minimizing movement of the baby. If urgent access to the baby is necessary during the imaging process, the baby can typically be removed from the system in less than 30 seconds, the agency says.