FDA clears neonatal MRI system designed for NICU use

Eyas Medical Imaging Inc. has received U.S. Food and Drug Administration 510(k) clearance for a neonatal magnetic resonance imaging system designed specifically for newborns and infants, the company announced.

The Ascent3T Neonatal Magnetic Resonance Imaging System is a whole-body scanner optimized for neonatal and infant anatomy, allowing imaging of the head, body and extremities. The company said the system is the world’s first dedicated high-field 3 Tesla neonatal MRI platform.

“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 chief executive officer of Eyas Medical Imaging.

The system uses a 3T magnet designed to produce detailed imaging of vital anatomy, including the brain, lungs, heart and abdomen. According to the company, the technology addresses limitations associated with using adult-sized MRI systems to image newborns and aims to improve clinicians’ ability to diagnose disease in neonatal patients.

Transporting fragile newborns from neonatal intensive care units to separate MRI suites has long posed safety challenges. The Ascent3T system is engineered with a compact footprint that allows installation directly in NICUs, reducing the need for transport. The scanner is also designed to be virtually helium-free and does not require a quench pipe or external venting, features intended to simplify installation in hospital units.

The technology was conceived at Cincinnati Children’s Hospital Medical Center and incorporates lessons from more than 1,700 infant MRI scans performed on prototype systems. It also includes a detachable patient table that can serve as a transport device, allowing hospitals flexibility in NICU workflows. The system incorporates advanced electronics, software and pulse-sequence technologies from Philips Medical Systems Nederland B.V.

“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,” said Charles Dumoulin, Ph.D., professor of pediatrics and radiology at Cincinnati Children’s and founder of Eyas Medical Imaging.

The company said it is scaling up operations and expects to begin U.S. commercialization later this year. The device is not yet commercially available outside the United States.

Advances reshape neonatal imaging and NICU diagnostics

Rapid technological innovation is transforming neonatal imaging, enabling clinicians to diagnose congenital conditions, neurological injuries and developmental abnormalities earlier and with greater precision than ever before.

Historically, imaging newborns has posed significant challenges. Conventional MRI systems were built for adults, often requiring infants to be transported out of the NICU, sedated and carefully monitored during lengthy scans. These logistical hurdles limited the frequency of MRI use in neonatal care, pushing clinicians toward alternatives such as ultrasound or computed tomography, which may offer lower diagnostic resolution for certain neurological and soft-tissue conditions.

In recent years, manufacturers and academic medical centers have focused on developing specialized neonatal imaging platforms that prioritize safety, accessibility and workflow integration. Compact MRI units designed for NICU installation allow scanning to occur near the infant’s bedside, reducing transport risks and minimizing interruptions to critical care monitoring. Improvements in coil design, motion-correction software and faster pulse sequences have also shortened scan times and improved image clarity in patients who cannot remain perfectly still.

At the same time, advances in artificial intelligence–assisted image reconstruction and analysis are helping radiologists detect subtle abnormalities earlier, particularly in areas such as hypoxic-ischemic brain injury, congenital heart disease and pulmonary disorders. Integration of neonatal imaging systems with hospital data platforms is also enabling more streamlined clinical workflows and longitudinal monitoring of infant development.

Together, these innovations are expanding the clinical role of MRI and other advanced imaging modalities in neonatal medicine. As specialized systems become more widely available, clinicians expect earlier diagnosis, improved treatment planning and potentially better long-term outcomes for premature and critically ill newborns.