Research & Development
IDx to market first autonomous, AI-based US FDA approved diabetic retinopathy diagnostic system IDx-DR
13 April 2018 -

Diagnostics company IDx reported on Thursday the receipt of the US Food and Drug Administration's (FDA) De Novo request to market the AI-based diagnostic system IDx-DR for the autonomous detection of diabetic retinopathy, a leading cause of blindness.

According to the company, IDx-DR is the first autonomous, AI-based diagnostic system authorised for commercialisation by the US FDA. IDx-DR makes an assessment without the need for a clinician to interpret the image or results, making it usable by health care providers who may not be involved in eye care.

The company said IDx-DR can be used to provide an immediate, reliable assessment for diabetic retinopathy, including macular edema, during a routine office visit in a primary care setting. The exam is performed on site in minutes and produces a diagnostic interpretation and associated report, including care instructions that are aligned with the American Academy of Ophthalmology preferred practice pattern for diabetic retinopathy.

This US FDA's marketing approval is based on IDx-DR's pivotal clinical trial conducted at ten primary care sites across the US under the US FDA's Breakthrough Devices programme. The primary care physician Michele Birch, MD, of CMC-Elizabeth Family Medicine and the University of North Carolina School of Medicine was one of the trial's principal investigators.

In conjunction with the approval, IDx-DR is available for immediate installation and is indicated for use with the Topcon NW400, concluded the company.

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