Eyas Medical Imaging has received 510(k) FDA clearance for its Ascent3T neonatal MR system, a 3 Tesla scanner designed specifically for imaging infants in the neonatal intensive care unit.

The Cincinnati-based company says the Ascent3T is the first dedicated 3T neonatal MR system on the market. Unlike conventional MR scanners, which are typically designed for adults, the Ascent3T is built for neonatal anatomy and can image the brain, heart, lungs and other vital organs in newborns. It also features a compact footprint suitable for installation directly within the NICU, reducing the risks associated with transporting fragile patients across the hospital.

A major design consideration, according to Eyas, was minimizing the use of liquid helium. The system operates with less than 2 liters and does not require a quench pipe or external venting, easing installation requirements. It also includes a detachable patient table that can be used for transport within the NICU.
The system was developed using clinical data from more than 1,700 infant scans at Cincinnati Children’s Hospital, where prototype systems were tested. Charles Dumoulin, a professor of pediatrics and radiology at Cincinnati Children’s and the company’s founder, said the technology is intended to “bring an unprecedented level of MR imaging and access to the most vulnerable patients when and where they need it.”

The Ascent3T incorporates imaging components and software from Philips Medical Systems Nederland B.V. Eyas expects to begin commercialization in the U.S. later this year. The device is not yet cleared for use outside the country.

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