The device can detect more than mild level of the eye disease diabetic retinopathy in adults who have diabetes, FDA said in a statement.
Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye.
It is the most common cause of vision loss among the more than 30 million Americans living with diabetes and the leading cause of vision impairment and blindness among working-age adults, according to FDA.
"Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50 per cent of them do not see their eye doctor on a yearly basis," said Malvina Eydelman from FDA's Center for Devices and Radiological Health.
"The decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor's office," said Eydelman.
Using the device, a doctor uploads the digital images of the patient's retinas to a cloud server on which IDx-DR software is installed.
If the images are of sufficient quality, the software provides the doctor with one of two results: "more than mild diabetic retinopathy detected: refer to an eye care professional" or "negative for more than mild diabetic retinopathy; rescreen in 12 months."
If a positive result is detected, patients should see an eye care provider for further diagnostic evaluation and possible treatment as soon as possible.
IDx-DR is the first device authorised for marketing that provides a screening decision without the need for a clinician to also interpret the image or results, which makes it usable by health care providers who may not normally be involved in eye care.
The FDA evaluated data from a clinical study of retinal images obtained from 900 patients with diabetes at 10 primary care sites.
The study was designed to evaluate how often IDx-DR could accurately detect patients with more than mild diabetic retinopathy.
In the study, IDx-DR was able to correctly identify the presence of more than mild diabetic retinopathy 87.4 per cent of the time.
It was able to correctly identify those patients who did not have more than mild diabetic retinopathy 89.5 per cent of the time.
Those with persistent vision loss, blurred vision, floaters, previously diagnosed macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion, should also refrain, the statement said.
Patients will still need to get a complete eye examination at the age of 40 and at the age of 60 and also if they have any vision symptoms, according to FDA.
(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)