US FDA Grants De Novo Request for IDx-DR’s AI Diagnostic System for Diabetic Retinopathy

April 13, 2018: By Jon Swedien
IDx-DR artificial intelligence diagnostic system

IDx-DR artificial intelligence diagnostic system

The FDA has granted IDx’ De Novo request to market the IDx-DR, an artificial intelligence (AI) diagnostic system for the autonomous detection of diabetic retinopathy, the agency announced April 12.

IDx-DR is the first autonomous, AI-based diagnostic system the FDA has authorized for commercialization, the agency said.

IDx-DR is designed to provide an immediate, reliable screening test for diabetic retinopathy, including macular edema, during a routine office visit in a primary care setting, Iowa-based IDx said. The IDx-DR makes an assessment without the need for a clinician to also interpret the image or results, making it usable by health care providers not normally involved in eye care, the company said.

“Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50 percent of them do not see their eye doctor on a yearly basis,” said Malvina Eydelman, MD, director of the FDA’s Division of Ophthalmic and Ear, Nose, and Throat Devices.

The exam is performed on site in minutes and produces a diagnostic interpretation and associated report, including care instructions that are aligned with American Academy of Ophthalmology guidelines for diabetic retinopathy, IDx said.

This enables primary care providers to counsel patients on follow-up care while they are still in the office, the company said.

IDx-DR received expedited review under the FDA’s Breakthrough Devices program following a pivotal clinical trial conducted at 10 primary care sites across the US, the company said.

IDx-DR is intended for use by health care providers to automatically detect more than mild diabetic retinopathy in adults above age 22 who are diagnosed with diabetes and have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400, IDx said.

A team of ophthalmologists at the University of Iowa Hospitals and Clinics founded IDx in 2010. The IDx-DR is the company’s first product.

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