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Fully Automated Diagnostic Device Receives CE Certification; IDx LLC Planning For Rollout Across Europe
Date:5/6/2013

IOWA CITY, Iowa, May 6, 2013 /PRNewswire/ -- IDx LLC, a company focused on deploying cutting-edge technology to make medical diagnostics more effective, announced earlier today that its first commercial product, IDx-DR, has received CE approval as a Class IIa medical device.  CE marking clears IDx-DR for sale in 31 countries that comprise the European Economic Area.     

Developed over the course of two decades by a team of the world's leading retina experts, IDx-DR software runs on a small computer and is capable of detecting diabetic retinopathy with greater sensitivity than trained physicians.  It works by running standard fundus photographs through a series of highly-advanced image filters that identify signs of the disease.  By tallying these measurements and comparing them to a disease index, the algorithms built into IDx-DR have been able to consistently outperform trained physicians in diagnosing referable diabetic retinopathy.

"This is a game-changer," said IDx CEO, Gary Seamans .  "CE IIa certification allows us to market a first-of-its-kind 'doc in a box' that heralds a new era for medicine."

"IDx-DR is also going to help keep a whole lot of people from going blind," Seamans added. Diabetic retinopathy is currently responsible for almost two million cases of blindness across the planet. The World Health Organization – along with many national health programs across Europe – recommends that every diabetic patient be screened regularly for the disease.   If diagnosed early enough, vision loss associated with diabetic retinopathy can be prevented in most cases. 

"Replacing a specialist's annual eye exam with software-based triage is good for doctors, it's good for patients, and it's good for anyone worried about the rising cost of healthcare," said IDx's co-founder and President,
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SOURCE IDx LLC
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