The US Food and Drug Administration (FDA) has granted 510(k) clearance for Eyas Medical Imaging’s Ascent³ᵀ neonatal magnetic resonance imaging (MRI) system, a device engineered specifically for the anatomy of neonates and infants.
The Ascent³ᵀ is said to be the first high-field, three Tesla (3T) MRI system dedicated to neonatal and infant imaging.
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It features a 3T magnet that enables comprehensive and detailed scans of vital organs such as the heart, lungs, abdomen, and brain.
The system addresses limitations found in using adult-size MRI systems for neonates by offering improved imaging and diagnostic options for clinicians treating these patients.
Eyas Medical Imaging stated that a major challenge in neonatal MRI has been the need to transport fragile newborns from the neonatal intensive care unit (NICU) to separate MRI suites within hospitals.
Its design overcomes this issue by offering a compact whole-body 3T neonatal MRI system that can be installed directly in the NICU.
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By GlobalDataThe system operates virtually helium-free and does not need a quench pipe or external venting.
The Ascent³ᵀ was developed based on expertise from Cincinnati Children’s, where more than 1,700 infant MRI scans were conducted using prototype systems. Its features include a detachable patient table that doubles as a transport device, aiding workflow flexibility within the NICU.
The technology also integrates operating software, advanced electronics, and pulse sequences from Philips Medical Systems Nederland.
Eyas Medical Imaging president and CEO Matt Storer said: “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 Imaging is currently scaling up operations with plans to commercialise Ascent³ᵀ in the US later this year. The device is yet to be commercially available in other countries.
