FDA grants clearance for Eyas Medical Imaging’s neonatal MRI system

Eyas Medical Imaging is currently scaling up operations with plans to commercialise the system in the US later this year.

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.

It features a 3T magnet that enables comprehensive and detailed scans of vital organs such as the heart, lungs, abdomen, and brain.

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