Visunex Receives FDA Clearance On Panocam Pro Wide-Field Imaging System
Visunex Medical Systems, Inc. announced the FDA clearance of the Visunex Medical Systems PanoCam Pro Wide-field Imaging System for the imaging of all newborn infants.PanoCam Pro is a wireless imaging system that fills an unmet need in the imaging of all newborn babies that may help detect external, anterior, and posterior segment vision disorders that may have long-term effects on the vision of millions of children around the world each year.
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Newborn vision screening is already a clinically valued and established method for evaluating Retinopathy of Prematurity (ROP) and Retinoblastoma (RB) which are life-threatening and can lead to newborn vision loss.
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The PanoCam Pro allows for complete visualization of the surface and sub-surface retinal pathologies unlike any other device on the market. Being able to detect and monitor vision disorders with this technology represents a significant breakthrough. Newborn eye testing is most commonly performed when a child enters Kindergarten at the age of 5 or 6 year old. There is clinical data that suggests that newborn vision disorders may affect between 10 and 20 percent of newborns around the world.