Diabetic retinopathy detection system IDx-DR approved by the US FDA
According to foreign media reports, IDX, located in Iowa, has revealed that it has obtained approval from the Food and Drug Administration (FDA) of the US health regulatory agency to launch its artificial intelligence IDx-DR diabetic retinopathy detection system. This is the first device approved in the United States to diagnose medical conditions independently without the need for a specially trained clinician to review.
The device is designed to provide simple screening options for general practitioners and other physicians who treat diabetes but do not receive eye diagnostic training. This performance of the device may greatly increase the number of diabetic patients being screened because many of them do not often visit an ophthalmologist.
The system uses a fundus camera to take two color photos at a 45-degree angle and then transfer those images to an online server, which will receive an online diagnostic report. The patient can then go home or be referred to an eye care professional for treatment.
The system has been approved for use in Europe since 2016, and a recent trial showed that nearly 90% of its ability to detect diabetic retinopathy promotes current FDA approval.
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