The next generation of visual pathway diagnostics.
Irvine, California (PRWEB) November 14, 2014
Konan Medical, a global leader in innovative diagnostic devices for the ophthalmic industry today announced that it has launched its newest device, EvokeDx – the next-generation visual pathway diagnostics platform to assess visual evoked potentials (VEP) and electroretinograms (ERG).
VEPs are visually-elicited, electrophysiological signals recorded near the brain’s visual cortex. EvokeDx provides highly quantitative, objective measures of visual function. ERG signals are used to differentially assess retina-specific dysfunction, reflecting the integrity of the eye’s optics, photoreceptors, bipolar cells and retinal ganglion cells, providing a limited assessment of the visual pathway.
icVEP is the patented, isolated-check stimulus and analysis strategy that was the subject of an NIH-sponsored, multi-center clinical trial at four prestigious US sites and two international locations to rapidly and objectively assess glaucomatous damage. “In the NIH-sponsored trials, our icVEP strategy had a classification accuracy of 89 to 94%,” said Vance Zemon, PhD, a professor at Yeshiva University, Albert Einstein College of Medicine Campus and co-inventor of EvokeDx. A glaucoma diagnostic indication based upon these data was recently granted for the icVEP strategy in China. EvokeDx is FDA 510(k) cleared and the CE Mark is anticipated in the first half of 2015 (an application for glaucoma diagnostic indication has not yet been submitted to FDA for review).
EvokeDx was recently unveiled at the world’s largest Ophthalmology meeting, the American Academy of Ophthalmology (AAO) in Chicago. “We worked closely with Dr. Zemon’s team to develop a visual pathway diagnostics platform that is elegantly designed, easy to use, reasonably priced and, most importantly, exceeded the high technical standards essential for clinical electrophysiology of vision.” said Dr. Charles Stewart, chief executive officer at Konan Medical. “The strong positive response to EvokeDx from the global ophthalmic communities at AAO and the ESCRS is a good indication that we achieved that goal.”
EvokeDx market-leading features include patented test strategies that are designed to isolate and test various visual pathways and visual functions, with Fourier-transform frequency analysis methods, and an all-in-one design incorporating a state of the art organic LED stimulus display and an automated gaze tracking system that helps ensure patients are fixated correctly during the procedure. Synchronized data collection combined with proprietary analysis of the entire EEG waveform provides detailed information about visual pathway function not available with previous generation devices.
About Konan Medical USA, Inc.
Headquartered in Irvine, California, Konan Medical USA Inc. develops specialized diagnostic products for eye care clinicians and eye banks. The company also provides diagnostic equipment and support services to many of the leading ophthalmic manufactures in support of sponsored FDA clinical trials research in the United States and Internationally. For more information visit http://www.KonanMedical.com