First AI-based device to detect diabetic retinopathy approved by FDA

23 April 2018 (Last Updated April 23rd, 2018 11:48)

The US Food and Drug Administration (FDA) has authorised for marketing the first medical device to use artificial intelligence (AI) to detect diabetic retinopathy (DR).

First AI-based device to detect diabetic retinopathy approved by FDA

The US Food and Drug Administration (FDA) has authorised for marketing the first medical device to use artificial intelligence (AI) to detect diabetic retinopathy (DR).

Leading cause of vision impairment and blindness

Diabetes mellitus is a chronic metabolic disorder that affects 422 million people worldwide and accounts for 2.6% of global blindness.

The main cause of vision loss associated with diabetes is DR, where the poor control of blood sugars and high blood pressure can lead to the damage of blood vessels inside the retina.

DR is the leading cause of blindness in working age populations but is neglected in healthcare research and planning in low-income countries, where access to eye-care professionals and services are in short supply.

A software program that uses an AI algorithm

The IDx-DR medical device uses AI to analyse images of the eye taken with a retinal camera, which are then uploaded to a cloud server where the program is installed.

Once analysed, two results are provided: “more than mild diabetic retinopathy detected: refer to an eye care professional” or “negative for more than mild diabetic retinopathy; rescreen in 12 months.”

The FDA evaluated data from a clinical study that found that the IDx-DR was able to correctly identify the presence of more-than-mild DR 87.4% of the time and identify those patients who did not have more-than-mild DR 89.5% of the time.

 

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