Pioneering diabetic retinopathy device gets US approval

Benedict Jephcote
Thu, 12 Apr 2018
Pioneering diabetic retinopathy device gets US approval
A device that uses artificial intelligence to detect diabetic retinopathy in its early stages has been given the go ahead for use in America.

The innovative software programme called IDx-DR works with a specialised retina camera analysing images taken of the back of the eye. The technology is able to provide the healthcare team with results which either suggests the person has mild retinopathy starting to develop or that their eyes are clear and no problem has been found.

Diagnosing diabetic retinopathy early means the person can be referred to a specialist straightaway, meaning treatment can be sought fast, preventing the condition from getting worse.

The device is thought to be a game changer for the medical profession as it alleviates the need to have an expert evaluate the image results. This means the technology could be used by healthcare teams who do not normally work within eye care.

The decision to make the device available to people in America was made by the US Food and Drug Administration (FDA). The IDx-DR was subject to a clinical study where researchers used 900 retinal images from across 10 different sites. The programme was correct in identifying mild diabetic retinopathy 87.4 per cent of the time and was 89.5 per cent accurate in identifying those who did not have the condition.

Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health, said: "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 percent of them do not see their eye doctor on a yearly basis.

"Today's decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor's office."

Diabetic retinopathy is a complication of diabetes that develops when a person experiences high blood sugar levels frequently and the retina's blood vessels become damaged as a result. The condition is the leading cause of blindness or visual impairment among adults in both the UK and the US but can be prevented through keeping sugar levels in a healthy range.

Many people have found Diabetes.co.uk's Low Carb Program helps them to get blood sugar levels down to healthy levels. Following the program has also helped a significant proportion of people to reduce the amount of diabetes medication they take.
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