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Konan Medical Introduces EvokeDx, a Next Generation VEP + ERG Vision Diagnostics Platform


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Product: EvokeDx
Top Line: Konan Medical is launching its newest device, EvokeDx, a next-generation visual pathway diagnostics platform to assess visual evoked potentials (VEP) and electroretinograms (ERG).
Close Up: VEPs are vision-produced, 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 five 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 percent,” 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 this data was recently granted for the icVEP strategy in China. EvokeDx is FDA 510(k) cleared and the CE Mark is anticipated the first half of 2015 (an application for glaucoma diagnostic indication has not yet been submitted to FDA for review).
Vital Stats: EvokeDx 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.; (949) 521-7730