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The product, IDx-DR, is an AI-based diagnostic system meant to be used as a standalone screening tool for diabetic retinopathy. Last week, the company announced that it submitted an application with the FDA, which the agency accepted with a “breakthrough device” designation. In other words, based on its ability to address an unmet medical need, FDA will provide a faster review.
Early screening and treatment of diabetes-related eye damage can prevent blindness in more than 90 percent of cases. Yet it’s often asymptomatic in the early stages and once it progresses, there’s no going back.
Regular screening is, therefore, a critical part of managing the disease. But that’s easier said than done. Patients with diabetes are usually treated in a primary care setting. The doctor will examine their feet and kidneys for signs of damage; they’ll check their blood sugar and insulin levels, and write any necessary prescriptions.To screen for retinopathy, patients need to be referred out to a specialist. The challenge isn’t the science, it’s ensuring patients can access and afford an annual eye test on top of their healthcare needs.
Abràmoff’s idea was to develop an algorithm that could interpret images of the retina and diagnose the disease without the need for a trained retinal specialist.If approved, the company believes IDx-DR would be the first autonomous, AI device intended for use in the front lines of healthcare. Unlike other medical imaging technologies that use AI, the system made by the Iowa company, is designed to make a directive, not a recommendation.
