World's first 3T MRI dedicated to neonatal imaging earns FDA clearance
A new MRI system designed specifically for imaging of neonates and infants has just been cleared by the U.S. Food and Drug Administration.
Cincinnati-based Eyas Medical Imaging announced the clearance of its Ascent3T on Thursday. Eyas cited the clearance as the first in the world for a 3T neonate-specific MRI system.
Cincinnati Children’s Hospital played a pivotal role in the scanner’s design and development. Experts there observed over 1,700 infant MRI scans on prototypes to get a better idea of how to design the system so it could achieve diagnostic quality in real-world settings.
“We took great care in the design of the Ascent3T. 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,” MR physicist Charles Dumoulin, PhD, a professor of pediatrics and radiology at Cincinnati Children’s and the founder of Eyas Medical Imaging, said in an announcement.
The clearance addresses numerous issues related to imaging of infants, including those pertaining to the challenging task of transporting newborns and babies from the neonatal intensive care unit to the radiology department. Ascent3T was designed with smaller spaces in mind, enabling installation in or very near NICUs. Its helium-free engineering also reduces space and infrastructure-related installation barriers, as it does not require specialized ventilation.
“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,” added Matt Storer, president and CEO of Eyas Medical Imaging.
Eyas is in the process of increasing production to commercialize the system in the U.S. That is expected to come later this year.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.