EyeIC Receives FDA 510(k) Clearance For MatchedFlicker(TM) Retinal Aid Detection Technology

Main Category: Eye Health / Blindness
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 11 Jun 2009 - 5:00 PDT

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EyeIC, an innovator of eye care solutions for ophthalmologists and optometrists, announced today that its MatchedFlicker(TM) technology has received FDA 510(k) clearance from the United States Food & Drug Administration (FDA). 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 enables 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 technology is an aid to change detection that addresses a rapidly growing market for glaucoma monitoring. In the U.S., glaucoma is the second leading cause of irreversible blindness with 10% of the population over the age of 40 at risk (World Glaucoma Association). It is estimated that over four million Americans have glaucoma, but only half of those know they have it (Prevent Blindness America). The U.S. Department of Labor estimates approximately 56,000 eye care professionals in the U.S. today.

"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."

EyeIC was founded in 2004 with a portfolio of intellectual property from the University of Pennsylvania. In November, the company completed a Series A round of $1.9 million in fundraising from MentorTech Ventures, Ben Franklin Technology Partners, private investors and its founder.

"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."

EyeIC expects to make available a commercial solution that fully integrates into the current workflow of the eye doctor's office by July of 2009. The company will exhibit at the World Glaucoma Congress on July 8-11 in Boston.

About EyeIC

EyeIC is a medical device company focused on eye care solutions. The company has developed its MatchedFlicker(TM) technology that allows eye care professionals to better monitor the progression of glaucoma and other eye diseases through faster detection and improved interpretation and documentation of retinal photographs. EyeIC was founded in 2004 with a portfolio of intellectual property from the University of Pennsylvania and recently completed a Series A round of $1.9 million in fundraising from MentorTech Ventures, Ben Franklin Technology Partners, private investors and its founder.

Source: EyeIC