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FDA Grants 510(k) Approval To EyeIC’s MatchedFlicker Retinal Aid Detection Technology

EyeIC announced that its MatchedFlicker technology has received US FDA 510(k) clearance. MatchedFlicker is a device-agnostic, software-only solution that uses time series retinal photographs to help doctors monitor the advent and progress of glaucoma faster and with accuracy now available to only a few experts.

The technology assists eye care professionals to compare two retinal images taken at different visits from the same patient from nearly any source and see change brought to life as motion. After the doctors make their evaluations, they have the ability to mark the changes on the flicker and on the images. The software also translates markings made on any image in a Flicker project to the appropriate location on all other images in the same project. All images and annotations are saved in an electronic format and can be printed.

We are very optimistic that our MatchedFlicker technology will address the pervasive problem of early change detection in glaucoma, said Ira Wallace, CEO of EyeIC. Currently, the gold standard for detecting retinal changes is done by glaucoma trained experts that compare separate pairs of stereo photos side by side, which makes it difficult to find and document changes between images. MatchedFlicker provides eye care professionals with a technology for faster detection, improved documentation and an easy-to-use electronic format that enables collaboration among multiple doctors across town or across the globe.

EyeIC’s MatchedFlicker offers ophthalmologists a powerful new tool for the detection of progressive glaucoma, said Nathan Radcliffe, M.D., Director of Glaucoma at Weill Cornell Medical College and New York-Presbyterian Hospital. MatchedFlicker automatically aligns and alternates serial optic disc photographs, allowing the clinician to quickly inspect each photographic set for small changes of the neuroretinal rim and vasculature.

Radcliffe added, Subtle features that might escape detection on side by side review of photographs, such as faint disc hemorrhages or peripapillary atrophy progression, can be spotted easily and in a matter of seconds. The software package is intuitive to use and offers a variety of mark-up tools that facilitate report generation and will work well with most EMRs. In my practice, MatchedFlicker has allowed me to make excellent use of historical optic nerve photos and plays a unique role in the detection of progressive glaucoma.

We are extremely pleased with EyeIC’s the 510(k) clearance for MatchedFlicker, said Michael B. Aronson, a Board Member of the Company and Managing Director of MentorTech Ventures. I am impressed by the Company’s business model for developing innovative software products that will dramatically improve the diagnostic standard of care for a large number of people afflicted with eye disorders.