The device, called IDx-DR and produced by Iowa-based IDx LLC, is the first to receive Food and Drug Administration authorization that provides a screening decision without need for a clinician to also interpret the image or results. That makes it usable by health care providers not normally involved in eye care, such as primary care physicians who interact far more frequently with patients with diabetes. It was reviewed under new FDA regulations designed to speed to market some devices seen as low- to moderate-risk and for which there is no prior legally marketed device, part of Commissioner Scott Gottlieb's efforts to streamline approvals on a variety of fronts, including generic drugs and cheaper versions of costly biotech medicines. "The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed health care," Malvina Eydelman, who oversees the agency's division of ophthalmic, and ear, nose and throat devices, said in a statement. IDx-DR will be used to detect diabetic retinopathy, in which high levels of blood sugar lead to damage in the blood vessels of the retina and vision loss.

Google Explores Use Of Machine Learning To Detect Diabetic Eye Disease By Jaikumar Vijayan Posted 2016-11-29 Print Researchers from the company this week published a paper describing a new deep learning algorithm for detecting signs of diabetic retinopathy. Google is hoping to apply its machine learning expertise to help doctors identify patients at risk of diabetic retinopathy (DR) early enough in the disease cycle to be able to treat them effectively. Researchers from the company this week published a paper in the Journal of the American Medical Association (JAMA) describing a deep learning algorithm for interpreting early signs of DR from retinal photographs. The paper titled "Development and Validation of a Deep Learning Algorithm for Detection of Diabetic Retinopathy in Retinal Fundus Photographs" is based on data that Google researchers developed with help from doctors and researchers in various hospitals and universities in the U.S. and India. The goal is to help doctors screen and identify patients in need for DR treatment especially in areas where the specialized ophthalmological skills needed for such diagnosis are in short supply.

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