CST: 31/08/2016 10:57:19   

Visunex Receives FDA Clearance on PANOCAM PRO Wide-Field Imaging System

174 Days ago

Revolutionary Vision Diagnostic System for Newborns in the Neonatal Intensive Care Unit, Operating Room and Maternity Clinics All Over the World

FREMONT, CA --(Marketwired - March 09, 2016) - Visunex Medical Systems, Inc. today 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.

"We are launching the PanoCam Pro, which is a key product to help Ophthalmologists and Maternal Clinicians identify vision disorders to help preserve vision in the NICU, OR, Birthing Centers and Clinical Offices. Our PanoCam Pro and PanoCam Review Software will help clinicians identify vision disorders that may be reversed to preserve healthy vision," said Visunex Medical Systems CEO, Dr. Wei Su.

In the United States there are an estimated 4 million children born each year. The number of newborn infants each year has been approximately 130 million for the past three years. These newborns are subject to a number of required tests that are mandatory which include hearing screening and bilirubin testing. Hearing screening figures show that approximately 1 in 300 children born may have hearing impairment. The test is performed before the newborn is discharged to home. Early research done in Asia, Brazil and the United States suggests that 1 in 70 children born may have some form of vision disorder.

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. 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. While many of these catalogued disorders may be thought of transient, 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 which is a significant vision disorder which may have long-term effects of a patient's vision. Other vision disorders may be detected, and if detected early, can give caregivers the opportunity to intervene and provide the treatment and can to thwart vision loss and improve care pathways and newborn vision into adulthood.

Darius M. Moshfeghi, MD, Director of Pediatric Vitreoretinal Surgery and Ophthalmologic Telemedicine at Stanford University, stated, "The advent of technology that helps assess the structures and function of the retina, combined with software solutions that elevate patient care is a huge step forward." Dr. Moshfeghi runs the Stanford University Network for the Diagnosis of Retinopathy of Prematurity (SUNDROP) which is the largest network looking at the care of premature infants who may be at the greatest risk of newborn vision disorders.

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.visunexmedical.com

Company contact:
Shalini Swamy
Director of Marketing
Phone: 510-996-4720 X412
shalini.swamy@visunexusa.com