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AI-based diabetic retinopathy diagnostic tool achieves FDA trial endpoints

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A pivotal FDA trial of an artificial intelligence-based system for the autonomous detection of diabetic retinopathy has met its endpoints, according to a press release from IDx.

The IDx-DR system, developed to assess for diabetic retinopathy during routing office visits with primary care providers, was granted expedited review under the FDA’s breakthrough device program.

The trial, which included 900 patients with diabetes, was conducted at 10 primary care sites across the United States. It evaluated the diagnostic accuracy of IDx-DR in detecting moderate to severe diabetic retinopathy, including macular edema, the release said.

“We are very pleased with the diagnostic accuracy and look forward to FDA’s expedited review,” Michael Abràmoff, MD, PhD, IDx’s founder and president, said in the release.