The FDA said Wednesday it will permit marketing of IDx-DR for the detection of diabetic retinopathy in adults, the first medical device that uses artificial intelligence (AI) in this setting. It occurs when high blood sugar damages blood vessels in the retina. On the server, IDx-DR applies an AI algorithm to analyze the images and determines whether the patient has more than a mild case of diabetic retinopathy.
A regulatory milestone: The FDA has recently cleared a few other products that use AI. The device and software can be used by health care providers who don't normally provide eye care services.
If the software detects more than mild diabetic retinopathy, it suggests referring the patient to an eye care professional for more in-depth diagnostic evaluation.
"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.
The automatically shading contact lenses are recommended to be used on a daily basis to correct vision impairments in those people who are nearsighted or farsighted.
FDA reviewed scientific evidence including a clinical study of 24 patients that evaluated daytime and nighttime driving performance while wearing the contact lenses. The study was created to evaluate how often IDx-DR could accurately detect patients with more than mild diabetic retinopathy. IDx-DR accurately identified the presence of diabetic retinopathy 87.4 percent of the time, and accurately identified those without the disease 89.5 percent of the time. Patients should also not get IDx-DR screening if they have floaters, macular edema, retinal vein occlusion, persistent vision loss, blurred vision, proliferative retinopathy, severe non-proliferative retinopathy, or radiation retinopathy.
Patients who have a history of laser treatment, surgery or injections in the eye should not be screened for diabetic retinopathy with IDx-DR, FDA said.
It was reviewed under new FDA regulations created 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. It was developed by privately held IDx LLC.