Eyas™ Medical Imaging Receives FDA 510(k) Clearance for Ascent3T™ Neonatal MRI System

Eyas Medical Imaging, Inc. has received U.S. Food and Drug Administration 510(k) clearance for its Ascent3T™ Neonatal Magnetic Resonance Imaging System. 

The system is designed specifically for neonates and infants, enabling detailed imaging of the head, body, and extremities.

The Ascent3T is the first high-field, 3 Tesla (3T) MRI system dedicated entirely to neonatal imaging. Its high-field magnet provides precise, comprehensive imaging of critical anatomy, including the brain, lungs, heart, and abdomen. 

Unlike adult-sized MRI systems, it overcomes technical limitations in imaging newborns, allowing clinicians to better visualise and diagnose conditions in this vulnerable population.

A major challenge for neonatal MRI has been safely transporting fragile infants from the neonatal intensive care unit (NICU) to conventional MRI locations. 

The Ascent3T addresses this by offering a compact, whole-body 3T system that can be installed directly in the NICU. It is almost helium-free and does not require quench pipes or outside venting. 

The system also includes a detachable patient table that doubles as a transport device, improving workflow and patient safety.

Developed with expertise from Cincinnati Children’s Hospital and advanced imaging technology from Philips, the Ascent3T is designed to bring high-quality MRI to neonates when and where it is needed.