FDA approves the sale of the first medical device using AI to detect diabetic retinopathy

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The US Food and Drug Administration (FDA) gaves its approvalon April 11 for the launch of a first medical device using artificial intelligence to detect adiabetic retinopathy from a photo.

This device was developed by the American company IDx, founded by the ophthalmologist Dr. Michael Abramoffin 2010.

Aiming to provide access to eye care to as many people as possible,the FDA, affirms that it « will continue to facilitate the availability of safe and effective digital health devices that can improve patient access to necessary health care ».

The detection of diabetic retinopathy, only allowed in adults from the age of 22, will be done through an algorithm able to detect ophthalmic pathology by analyzing photos.

The FDA affirms “This program allows the commercialization of an AI device that makes it usable by health professionals who are not normally licensed to provide eye care. »

The health professional consulted will upload the pictures of the patient’s retinas to a cloud server on which the IDx-DR software is installed.

If the quality of the images is high enough, the software will compare them to the thousands of others it contains and provide the doctor two results options: “diabetic retinopathy detected: refer to an eye care professional” or “retinopathy negative diabetic: see a professional in 12 months “.

Before authorizing this new device, the FDA tested the device which was effective in 9 out of 10 cases.

There are however restrictions and patients who have undergone laser eye treatment, patients with ocular degeneration or pregnant women should not use IDx-DR, whose results would be less reliable.

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