Fully Automated Diagnostic Device Receives CE Certification; IDx LLC Planning For Rollout Across Europe
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, Dr. Michael Abramoff.
"It means one less doctor's visit for patients with diabetes, who will now be able to have screening done at their primary care or optometrist's office. It means a new source of revenue for the practitioners providing these screenings – which we think is going to drive adoption. And for the health care system as a whole, there are going to be tremendous cost savings associated with better screening compliance, increased early detection, and more efficient deployment of medical specialists."
IDx-DR represents the first in a series of diagnostic algorithms that IDx believes will ultimately transfer eye-related disease screening from the offices of ophthalmologists to patients' medical homes – whether those be family doctors or retail health clinics.
"The back of the eye is very much a 'window' into human health," explained Dr. Abramoff. "Retinal images allow doctors literally to peek inside the body, where blood vessels and nerve tissue provide a wealth of data about a patient's physical health status." Some of this information can be used to diagnose eye diseases, like retinopathy, macular degeneration and glaucoma, but fundus photos can also be used to determine which patients are at an increased risk for stroke and heart attack.
"The appearance of retinal veins and arteries are real-time health indicators that can all be measured rapidly, painlessly, and non-invasively, using advanced algorithms. IDx-DR is the first in a series of diagnostic algorithms this company is developing."
Software for these diagnostic technologies will be based on a series of exclusively licensed patents held by the University of Iowa, where the company's two principal founders, Dr. Michael Abramoff and Dr. James Folk, both retina specialists, hold clinical and academic appointments.
IDx's Recent History
In 2010, the company came under the veteran leadership of CEO Gary Seamans. Prior to joining IDx, Mr. Seamans directed operations, engineering, marketing, sales, human resources, finance, and strategic planning divisions during a thirteen-year executive management career with AT&T, served with distinction in the U.S. Air Force, and more recently led Westell Technologies as chairman and CEO. Mr. Seamans has been involved with vision research for a number of years as a founding board member of the Institute for Vision Research.
"We have been able to assemble funding for IDx in a relatively short time frame from investors around the country thanks to the advanced stage of the products and also because people are sympathetic to the greater good that's going to result from deploying IDx's algorithms," Seamans said. "People recognize that technology holds the potential to bend the health care cost curve and at the same time preserve, and even enhance, patient care."
The next step for the company, which is already ISO13485 certified, will be obtaining approval for the IDx-DR from the United States Food and Drug Administration. A clinical trial is underway and conversations with the FDA are ongoing.
IDx is currently in discussions with several major healthcare device manufacturers and distributors with both domestic and international networks. The company hopes to conclude major distribution partnership arrangements this year.
"CE approval for IDx-DR is a major leap forward for improving healthcare efficiency," said President Dr. Abramoff, "But we're just getting started."
SOURCE IDx LLC