Visunex Medical Wins FDA Approval for Revolutionary Imaging Device for Vision Screening of All Newborn Infants
- First completely wireless, hardware and software solution for imaging all newborns
FREMONT, Calif., Nov. 18, 2015 /PRNewswire-iReach/ -- Visunex Medical Systems, Inc. today announced the FDA clearance of the PANOCAM LT Wide-field Imaging System for the imaging of all newborn infants.
PanoCam LT is a compact, wireless imaging system that is designed to detect a number of 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. Clinical data suggests that vision disorders may affect between 10 and 20 percent of all newborns globally.
"We are launching the Panocam LT which is the first completely wireless, hardware and software solution to help Ophthalmologists and Maternal Clinicians identify vision disorders in newborns. Our PanoCam LT and the PanoCam Review Software will help clinicians identify newborn vision disorders, and if treated earlier it may preserve healthy vision," Visunex Medical Systems CEO, Dr. Wei Su.
An estimated four million children are born each year in the United States and approximately 130 million globally. At birth, newborns are subject to a number of mandatary tests which include hearing screening and bilirubin testing. Hearing impairment is detected in approximately 1 in 300 infants prior to being discharged from the hospital. Vision screening is not currently provided as standard of care in most neonatal centers. Early research conducted in Asia, Brazil and the United States suggests that 1 in 70 children born may have some form of vision disorder.
Most commonly, the first eye test performed on a child is prior to Kindergarten at the age of five or six. While many visual disorders may be transient, a growing number of clinicians believe that the screening of newborns may provide early detection of vision disorders, such as retinal hemorrhages, which may be a precursor to amblyopia. This serious vision disorder may have long-term effects or even permanently impair vision through adulthood. If detected early, retinal hemorrhages as well as many other serious disorders, can lead to early therapeutic intervention and potentially prevent vision loss.
Darius M. Moshfeghi, MD, Director of Pediatric Vitreoretinal Surgery and Ophthalmologic Telemedicine at Stanford University, stated, "The advent of effective hardware and software solutions can facilitate detection and monitoring of ocular disease in babies."
About the Company: Visunex Medical Systems is a pioneer in developing the best technology and information systems for preserving healthy vision for all newborn babies around the world. Based in Fremont, California, the Company will continue to deliver products and services to enhance global vision. For more information, visit www.visunexusa.com
Media Contact: Shalini Swamy, Visunex Medical Systems, 5109964720, shalini.swamy@visunexusa.com
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- vision disorders