Eyeworld

26 EW NEWS & OPINION by Liz Hillman EyeWorld Senior Staff Writer country. 6 In the study, the AI system was evaluated by the Wisconsin Fundus Photograph Reading Center (FPRC). Of the participants who could be evaluated by both the AI system and FPRC (819 patients), the AI system was shown to detect more than mild diabetic retinopathy at a sensitivity of 87.2% and specificity of 90.7%. Imageability was 95.6%. The study has been submitted for peer-review publication. There are many groups work- ing on assistive AI (AI that can help the physician decide on a certain diagnosis or treatment plan) that Dr. Abramoff said might make physi- cians better doctors, but it doesn't make them more productive. "I think an autonomous AI, which makes a decision by itself, is crucial," he said, giving an example of one of the clinical trial sites in New Mexico. It was at a clinic where patients, prior to this technology, could have all other aspects of their diabetes exam performed, except their eye exams. For that, an oph- thalmologist was 4 hours away. As a result, Dr. Abramoff said patients were foregoing retinal exams and losing vision. "We came in, trained clinic staff, and left, and then the staff was able to do high diagnostic- quality exams right there for anyone with diabetes in their practice. Now, instead of having to come to a retinal specialist, it's being done by the AI system right there. I think it's crucial." In addition to being the first AI medical diagnostic tool approved by the FDA, IDx-DR was reviewed through the FDA's Breakthrough De- vices Program, a program that seeks to expedite the FDA's review pro- cess for technologies that are more effective in diagnosis or treatment of life-threatening or debilitating diseases. 7 Malvina Eydelman, MD, director, Division of Ophthalmic and Ear, Nose and Throat Devices, Office of Device Evaluation, FDA's Center for Devices and Radiological Health, said at the 2018 OIS@ASCRS meeting that the review process for IDx-DR took 85 days after accep- tance into the program. camera (Topcon Medical Systems, Oakland, New Jersey). In the pivotal clinical trial, Dr. Abramoff and co-in- vestigators showed that those who had never seen or taken a retinal im- age before could be trained within 4 hours to use the IDx-DR system. The AI system guides the operator to take high-quality retinal images with the NW400 camera, and the diagnostic AI analyzes the images. "It says, this image was a little bit to the left of the disc, so you need to center it more, or retake this image because it was out of focus. It helps guide the operator to quickly get high-quality images," Dr. Abramoff said, explaining that after four high-quality images are obtained, the diagnostic AI software determines a diagnosis. This, he said, happens automatically at the point of care with a few clicks, and the information is then sent to the patient's electronic medical record and/or provided physically to a legally authorized provider who can discuss the results with the patient. It takes about 30 seconds for the AI system to make the clinical diagno- sis, Dr. Abramoff said. The pivotal trial for this tech- nology, which led to FDA approval, included 900 patients with diabetes from 10 primary care sites across the are not coming to eye care provid- ers for exams to identify disease in the first place. "I thought, this is an ideal way of using AI to improve this process, make it more efficient, better quality, and hopefully lower cost." In 2017, the American Dia- betes Association recommended that patients with type 1 and type 2 diabetes, after an initial retinal exam within 5 years of diagnosis and upon diagnosis, respectively, be screened for diabetic retinopathy every 2 years. 1 If diabetic retinopa- thy is detected, annual screening by an ophthalmologist or optometrist is recommended. The American Acade- my of Ophthalmology recommends annual dilated fundus exams for all patients with diabetes, and more of- ten for those with advanced diabetic retinopathy. 2 According to the Cen- ters for Disease Control and Preven- tion (CDC), 30.3 million Americans have diabetes. 3 The CDC's National Health Interview Survey in 2008 found that 53.4% of adult patients with diabetes had received a dilat- ed eye exam within the past year. 4 Other estimates have placed non-ad- herence to retinal exam recommen- dations at as high as 60%. 5 The IDx-DR system uses the Topcon NW400 robotic retinal IDx-DR is the first autonomous AI device to receive FDA approval for reaching a diagnosis without physician input A rtificial intelligence (AI) technology that detects diabetic retinopathy (DR) without oversight from a specialist became the first of its kind to receive approval from the U.S. Food and Drug Administra- tion (FDA) in April 2018. Since then, IDx-DR (IDx, Coralville, Iowa) has been imple- mented at primary care clinics that are part of large hospital systems, bringing fully automated, easy-to- use technology that can detect more than mild DR or macular edema into areas that might prove more accessi- ble and convenient to patients with diabetes. "I think it's huge. I've been working on this for 22 years. I start- ed this as scientific research because I realized how terrible this problem is of people with diabetes going blind," IDx founder and president Michael Abramoff, MD, PhD, said, adding that diabetic retinopathy can be managed to preserve vision, but the problem is that these patients First artificial intelligence system approved by the FDA to detect diabetic retinopathy IDx-DR is the first FDA-approved diagnostic device that uses artificial intelligence technology to reach a diagnosis without physician input. Source: IDx June 2018

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