Eyas Medical Imaging has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company's Ascent3T neonatal MRI system.
The system includes a whole-body magnetic resonance scanner designed for neonate and infant anatomy, including the head, body, and extremities.
The Ascent3T uses a 3-tesla magnet and addresses the technical limitations of using an adult-size MRI system to image babies. The system is also virtually helium-free and does not require a quench pipe or outside venting.
Ascent3T neonatal MRI systemEyas Medical Imaging
Features include a detachable patient table that can serve as a patient transport device, as well as advanced electronics, operating software, and pulse sequences from Philips Medical Systems Nederland B.V.
Eyas in 2023 installed the Ascent3T system within Cincinnati Children's Hospital's neonatal intensive care unit (NICU) and reported success from over 1,700 infant MRI scans on its prototype systems.
The company said it is scaling up operations and expects to bring the system to market in the U.S. later in 2026. The Ascent3T is not yet commercially available in other countries.
