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.
Go deeper with GlobalData
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.”
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataThe 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.
For more insight and data, visit the GlobalData Report Store – Verdict Medical Devices is part of GlobalData Plc.
