Fremont, Calif-based ophthalmic information system developer Visunex Medical said it won FDA 510(k) clearance for its PanoCam Pro Wide-field Imaging System designed for imaging newborn infants.
The PanoCam Pro is a wireless imaging system deisgned to help detect external, anterior and posterior segment vision disorders in newborns, which the company says may have long term effects on chilren.
“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,” CEO Dr. Wei Su said in a press release.
Visuneex Medical said the PanoCam Pro allows for the visualization of the surface and sub-surface retinal pathologies, which they claim is “unlike any other device on the market.”
“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. Darius Moshfeghi of Stanford University said in prepared remarks.
In November, Visunex 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.