FDA Grants 510(k) Clearance to Eyas’ Ascent3T Neonatal MRI System
Eyas Medical Imaging has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Ascent3T neonatal MRI system.
The system features a whole-body magnetic resonance scanner specifically designed for neonates and infants, enabling imaging of the head, torso, and extremities.
The Ascent3T is powered by a 3-tesla magnet and is engineered to overcome the technical challenges associated with using adult-sized MRI systems for infant imaging. It is virtually helium-free and does not require a quench pipe or external venting.
Key features include a detachable patient table that can also function as a transport device, along with advanced electronics, operating software, and pulse sequences developed by Philips Medical Systems Nederland B.V.
The system’s design is informed by experience gained from more than 1,700 infant MRI scans performed on prototype systems at Cincinnati Children’s Hospital. In 2023, Eyas installed a research-use-only Ascent3T system in the neonatal intensive care unit (NICU) at Cincinnati Children’s.
Eyas Medical Imaging stated that it is scaling its operations and plans to introduce the Ascent3T to the U.S. market later in 2026. The system is not yet commercially available outside the United States.
Source: Eyas Medical
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