US approves first AI-based device to detect diabetic eye disease

The US Food and Drug Administration (FDA) has permitted marketing of the first artificial intelligence (AI)-based medical device to detect certain diabetes-related eye problems.

The device can detect more than mild level of the eye disease diabetic retinopathy in adults who have diabetes, FDA said in a statement.

Called IDx-DR, the device is a software programme that uses an artificial intelligence algorithm to analyse images of the eye taken with a retinal camera called the Topcon NW400.

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."