The FDA approves the first device to detect eye diseases among diabetics
The FDA approves the first device to detect eye diseases among diabetics
The US Food and Drug Administration (FDA) has approved the first device - using artificial intelligence - to detect eye diseases among diabetics.
The new device is able to detect a higher level of mild retinal eye disease, a loss of vision that could affect more than 30 million Americans suffering from diabetes.
This is the main cause of visual impairment and blindness among working-age adults, including cases of "macular edema".
High blood sugar levels, in cases of retinopathy, damage the retinal blood vessels, the sensitive tissue of the back of the eye.
"The early detection of retinopathy is important in the health care of millions of people with diabetes," said Dr. Malfina Idelman, Ophthalmology, Nose and Throat (Ophthalmology) Director of the Department of Medicine and Radiation of the US Food and Drug Administration. Of patients are not adequately screened for diabetic retinopathy, because about 50% of patients do not go to the ophthalmologist on an annual basis. "
"The new device can be used to use AI technology at the doctor's clinic for primary care, and the US Food and Drug Administration will continue to facilitate the provision of safe and effective digital health devices that may improve access to the patient's healthcare."
The new device uses an artificial intelligence algorithm to analyze eye images taken with a network camera called Topcon NW400. The digital retinal images of the patient are then uploaded to the IDx-DR server. If a positive result is detected, patients can be referred to the eye care provider for more Diagnostic evaluation and treatment possible as soon as possible.