Eyas™ Medical Imaging Receives FDA 510(k) Clearance for the Ascent3T Neonatal Magnetic Resonance Imaging System

CINCINNATI--(BUSINESS WIRE)--Eyas Medical Imaging, Inc. has received 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,” said Matt Storer, President and CEO of Eyas Medical Imaging.

The Ascent^3T is the first high-field, 3 Tesla (3T) dedicated neonatal MRI system in the world. It utilizes 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’ innovative 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 one of the world’s top children’s hospitals, Cincinnati Children’s, incorporating learning from their over 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 Dumoulin², Ph.D., a professor of Pediatrics and Radiology at Cincinnati Children’s and the founder of Eyas Medical Imaging.

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.

^1 The Ascent^3T requires less than 2 liters of helium.

^2 Dr. Dumoulin has a financial interest in the success of the Ascent^3T.

About Eyas Medical Imaging:

Eyas Medical Imaging, founded in 2014, is comprised of an experienced team of MR scientists and engineers committed to bringing the best MRI technology to babies where and when they need it. Our Ascent^3T Neonatal MRI System is designed specifically for neonate and infant anatomy and can be installed directly within the NICU. It is the only high-field, 3T dedicated neonatal MRI system in the world, advancing our mission to enable healthcare professionals to save more babies’ lives with state-of-the-art, precision imaging. Eyas Medical Imaging: Where Neonatal Care Begins. For more information, please visit: eyasmri.com

Forward Looking Statements:

This press release may contain forward-looking statements, including statements regarding the commercialization and potential benefits of the Ascent^3T Neonatal Magnetic Resonance Imaging System, as well as our plans, expectations, and timelines. Forward-looking statements are based on current assumptions and involve risks and uncertainties that could cause actual results to differ materially. Factors that may cause such differences include risks related to manufacturing and supply, market adoption and payer coverage, regulatory requirements and post‑marketing commitments, safety or efficacy findings in real‑world use, competitive developments, intellectual property, and our ability to execute our plans. We undertake no obligation to update these statements except as required by law.