U.S. health regulators said on Wednesday it will allow sale of the first medical device that uses artificial intelligence (AI) software to detect greater than a mild level of the most common cause of vision loss among more than 30 million Americans living with diabetes.
The device, called IDx-DR and produced by Iowa-based IDx LLC, is the first to receive Food and Drug Administration authorization that provides a screening decision without need for a clinician to also interpret the image or results. That makes it usable by health care providers not normally involved in eye care, such as primary care physicians who interact far more frequently with patients with diabetes.
It was reviewed under new FDA regulations designed to speed to market some devices seen as low- to moderate-risk and for which there is no prior legally marketed device, part of Commissioner Scott Gottlieb’s efforts to streamline approvals on a variety of fronts, including generic drugs and cheaper versions of costly biotech medicines.
“The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed health care,” Malvina Eydelman, who oversees the agency’s division of ophthalmic, and ear, nose and throat devices, said in a statement.
IDx-DR will be used to detect diabetic retinopathy, in which high levels of blood sugar lead to damage in the blood vessels of the retina and vision loss.
The IDx-DR program uses AI software to analyze images of the eye taken with a retinal camera. The software tells the doctor that the patient either has more than mild diabetic retinopathy and should be referred to eye care professional for possible treatment, or is “negative” for more than mild diabetic retinopathy and should be rescreened in 12 months.
“Many patients with diabetes are not adequately screened for diabetic retinopathy since about 50 percent of them do not see their eye doctor on a yearly basis,” Eydelman said, noting that early detection is important for managing care.
In a clinical trial, IDx-DR was able to correctly identify the presence of more than mild diabetic retinopathy 87.4 percent of the time and identify those who did not have more than mild disease 89.5 percent of the time.
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