Devices & Diagnostics, Health IT

Digital imaging may bring diabetic eye disease screening to primary care

For America’s 25 million-plus diabetics and their insurers, annual visits to ophthalmologists for diabetic retinopathy […]

For America’s 25 million-plus diabetics and their insurers, annual visits to ophthalmologists for diabetic retinopathy screenings are costly and often unneeded. But a medical device startup’s disruptive technology could simplify and cheapen that costly screening and bring it into a primary care physician’s office.

IDx LLC’s first products are a hand-held retinal camera that takes digital photos through undilated pupils and a software system that uses proprietary algorithms to analyze those images. The IDx-DR software and RetiCam hardware would allow for diabetes patients to be screened for diabetic retinopathy, the most common diabetic eye disease that can cause visual disturbances and blindness, in a primary care physician’s office.

Screening for this condition, which is characterized by damage to the blood vessels in the retina, is traditionally conducted with expensive equipment by a specialist during a comprehensive dilated eye exam. Because there are often no early symptoms for this condition, the American Optometric Association recommends that diabetes patients get screened once a year.

Although nearly 30 percent of 25 million Americans with diabetes develop diabetic retinopathy, only 10 percent to 12 percent of them are actually recommended for treatment during that appointment. For most patients, this is a costly additional exam, said IDx Chairman and CEO Gary Seamans.

Seamans said the company is in the early stages of a clinical trial designed to show the effectiveness of the IDx-DR algorithm. It’s also in the process of raising $4.35 million. He declined to provide any time line for U.S. Food and Drug Administration filings, but said he is confident this trial will be very successful.

Other systems using digital retinal images to diagnose diabetic retinopathy are being developed or studied, including Automated Medical Diagnostics’ method, which sends digital pictures of the retina to a server to be compared with other images representing various stages of the disease.

But Seamans added that IDx’s algorithm has other applications in screening for cardiovascular disease and systemic infections.

“The retina is the only place in the human body where you can see in vivo arteries and veins without some kind of dye,” he said. “There is a whole bunch that can be obtained by looking into the back of the eye, and if you have a device that can take high-quality images and algorithms that can analyze them, that will fundamentally enhance the diagnostic process.”

IDx was founded by a group of four vision experts based on algorithms developed at the University of Iowa.

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