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FDA approves marketing of first AI device to detect diabetic eye disease

IANS  |  Washington 

The US (FDA) permitted on Wednesday the marketing of the first to use (AI) to detect greater than a mild level of the eye disease in adults who have

Diabetic retinopathy, the most common cause of vision loss for people living with diabetes, 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, reported.

"Early detection of is an important part of managing care for the millions of people with diabetes, yet many patients with are not adequately screened for since about 50 percent of them do not see their eye doctor on a yearly basis," said Malvina Eydelman, M.D., of Ophthalmic, and Ear, Nose and Throat Devices at the for Devices and Radiological

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

The device, called IDx-DR, is a that uses an to analyse images of the eye taken with a retinal camera called the NW400, according to FDA.

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, either "more than mild detected: refer to an eye care professional" or "negative for more than mild diabetic retinopathy: re-screen in 12 months."

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 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 at 10 primary care sites.

In the study, IDx-DR was able to correctly identify the presence of more than mild 87.4 per cent of the time and was able to correctly identify those patients who did not have more than mild 89.5 per cent of the time.

--IANS

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Thu, April 12 2018. 01:44 IST
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