FDA Clears Visunex Newborn Vision Imaging System

FDA has cleared a Visunex Medical Systems 510(k) for its Visunex Medical Systems PanoCam Pro Wide-field Imaging System for imaging newborn infants for vision disorders. The wireless device can help detect external, anterior, and posterior segment vision disorders that may have long-term effects, according to the company. The test is performed before a newborn is discharged to home.

“Newborn vision screening is already a clinically valued and established method for evaluating Retinopathy of Prematurity and Retinoblastoma, which are life-threatening and can lead to newborn vision loss,” Visunex says. The device allows for complete visualization of surface and sub-surface retinal pathologies, it says, adding that “many clinicians believe the vision screening of newborns with the PanoCam Pro may help shed additional light on the significance of disorders such as retinal hemorrhages which may be a precursor to amblyopia.”