FDA Clears Eyas Medical’s Ascent3T Neonatal MRI System

Eyas Medical Imaging Inc. has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its Ascent^3T Neonatal Magnetic Resonance Imaging (MRI) System, a whole-body magnetic resonance scanner designed and optimized specifically for neonate and infant anatomy, including head, body, and extremities.

“510(k) clearance marks a significant milestone for the company and reflects our mission to enable healthcare professionals to save more babies’ lives with state-of-the-art, precision imaging,” Eyas Medical President/CEO Matt Storer stated.

The Ascent^3T is billed as the world’s first high-field, 3 Tesla (3T) dedicated neonatal MRI system. It uses a 3T magnet, enabling a more comprehensive and precise diagnostic tool that provides healthcare professionals with detailed imaging of vital anatomy, including the brain, lungs, heart, and abdomen. The Ascent^3T addresses the technical limitations of using an adult-size MRI system to image babies and provides clinicians with improved ability to visualize and diagnose disease in the neonatal patient population.

A significant barrier to using MRI for neonates has been the risk of transporting fragile newborns from the neonatal intensive care unit (NICU) to alternate MRI locations within the hospital. Eyas’ engineering solves that problem by delivering a whole-body 3T neonatal MRI system with a compact footprint that allows direct installation in the NICU without sacrificing image quality. Unlike most conventional MRI systems, the Ascent^3T is virtually helium-free¹ and does not require a quench pipe or outside venting.

The Ascent^3T was conceived at Cincinnati Children’s Hospital, incorporating learning from the more than 1,700 infant MRI scans on prototype systems. It includes features such as a detachable patient table that can serve as a patient transport device, providing flexibility in NICU workflow based on hospital needs and preferences. The system also leverages advanced electronics, operating software, and pulse sequences from Philips Medical Systems Nederland B.V.

“We took great care in the design of the Ascent^3T. Our goal is to transform neonatal care by bringing an unprecedented level of MR imaging and access to the most vulnerable patients when and where they need it,” said MR physicist Charles Dumoulin,² Ph.D., a professor of Pediatrics and Radiology at Cincinnati Children’s and Eyas Medical Imaging founder.

The company is currently scaling up operations and expects to be in commercialization in the United States later in the year. The device is not yet commercially available in other countries.

Founded in 2014, Eyas Medical Imaging is comprised of experienced MR scientists and engineers committed to bringing the best MRI technology to babies. Its Ascent^3T Neonatal MRI System is designed specifically for neonate and infant anatomy and can be installed directly within the NICU. The company is based in Cincinnati.

References
¹ The Ascent3T requires less than 2 liters of helium.
² Dr. Dumoulin has a financial interest in the success of the Ascent^3T.