IDx’ AI-Based Diagnostics System Meets Endpoints in Pivotal Trial for DR

March 9, 2018: By Joan McKenna

IDx, a privately held artificial intelligence (AI) diagnostics company, announced Feb. 22 that its AI-based system for detection of diabetic retinopathy met its endpoints in a pivotal FDA trial of 900 people with diabetes.

The Iowa City, Iowa, company said the IDx-DR was developed to assess for diabetic retinopathy during routine office visits with primary care providers, with results available in minutes.

The trial was conducted at 10 primary care sites across US to evaluate the diagnostic accuracy of the IDx-DR in detecting moderate to severe diabetic retinopathy, including macular edema.

The company said it expects FDA clearance in 2018.

IDx also has products in development for the detection of macular degeneration, glaucoma, Alzheimer’s disease, cardiovascular disease, and stroke risk.

The company was founded by retina specialist Michael Abramoff, MD, PhD. It has a strategic partnership with IBM Watson Health to distribute its products in the EU.

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