The U.S. Food and Drug Administration (FDA) in April 2018 gave its first approval of an artificial intelligence (AI) algorithm for the detection of diabetic retinopathy (DR) in the offices of non-ophthalmic healthcare practitioners.1
IDx-DR (IDx, LLC) is paired with a non-mydriatic retinal camera (TRC-NW400, Topcon) and captures images that are sent to a cloud-based server. That server then utilizes IDx-DR software and a “deep-learning” algorithm to detect retinal findings consistent with DR based on autonomous comparison with a large dataset of representative fundus images.
The FDA statement says that if captured images “are of sufficient quality,” the software provides the doctor with one of two results:
• If more than mild DR detected, refer to an eyecare professional (ECP)
• If the results are negative for more than mild DR, rescreen in 12 months
1. U.S. Food & Drug Administration. FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604357.htm. Accessed 6/21/18.
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