FDA approves Eyas Medical Imaging’s neonatal MRI system
The U.S. Meals and Drug Administration (FDA) has granted 510(ok) clearance for Eyas Medical Imaging’s Ascent³ᵀ Neonatal Magnetic Resonance Imaging (MRI) System, a tool particularly designed for the anatomy of newborns and infants.
The Ascent³ᵀ is claimed to be the primary excessive area three Tesla (3T) MRI system devoted to new child and toddler imaging.
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It encompasses a 3T magnet that permits intensive and detailed scans of important organs equivalent to the center, lungs, stomach and mind.
The system addresses the constraints related to utilizing grownup MRI programs for neonates by offering improved imaging and diagnostic choices to physicians treating these sufferers.
Eyas Medical Imaging states {that a} main problem in neonatal MRI is the necessity to transport susceptible newborns from the neonatal intensive care unit (NICU) to separate MRI suites in hospitals.
The design solves this downside by providing a compact whole-body 3T MRI system that may be put in straight within the NICU.
The system operates just about helium-free and doesn’t require a fireplace extinguisher or exterior venting.
The Ascent³ᵀ was developed primarily based on the experience of Cincinnati Kids’s, the place greater than 1,700 MRI scans of infants had been carried out utilizing prototype programs. Options embody a detachable affected person desk that doubles as a transport system, enhancing workflow flexibility throughout the NICU.
The expertise additionally integrates management software program, superior electronics and pulse sequences from Philips Medical Methods Netherlands.
Eyas Medical Imaging president and CEO Matt Storer stated, “510(ok) clearance marks an vital milestone for the corporate and displays our mission to empower healthcare professionals to avoid wasting the lives of extra infants with state-of-the-art, precision imaging.”
Eyas Medical Imaging is at present scaling its enterprise with plans to launch Ascent³ᵀ within the US later this yr. The system has but to be commercially accessible in different nations.
