Fremont, Calif-based ophthalmic information system developer Visunex Medical said it won FDA 510(k) clearance for its Panocam LT wide-field imaging system for newborns.
The PanoCam LT is a small wireless imaging system designed to detect external, anterior and posterior segment vision disorders that could have long-term effects on children’s vision, the company said.
“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,” CEO Dr. Wei Su said in prepared remarks.
Vision screening is not currently provided as a standard of care in most neonatal centers, Visunex said, but research suggests that 1 in 70 children born may have some form of vision disorder.
“The advent of effective hardware and software solutions can facilitate detection and monitoring of ocular disease in babies,” Dr. Darius Moshfeghi of Stanford University said in a press release.