The FDA (American Food and Drug Administration) allowed an artificial intelligence to perform a medical diagnosis for the first time and this, without having a doctor checking the results afterwards.
It is the first time the FDA allows the operation and the marketing of a system provided with artifical intelligence. This tool, called iDx-DR, can detect whether or not an examined patient is affected by diabetic retinopathy. This disease is caused by high sugar levels damaging the blood vessels. It can result in partial or complete blindness and is a common diabetes complication.
To proceed and determine whether a patient is affected by this infection or not, the health personnel of an medical establishment has to capture the patient’s retina thanks to the Topcon NW400 camera and adds these shots to the iDx-DR servers. The machine then has two possible outcomes, either “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 also explains that no doctor or nurse has to check the results or to proceed to a new test after the IA test. The tool wa granted the “Breakthrough Device” designation, allowing to non-specialists (general practitioners or nurses) to run this test without having to send patients to specialists. As of today, very few diabetes patients get their view examined regularly.
In a press release, the American administration adds that every American person has to get its vision checked by a professional care giver at 40 and 60, or everytime a vision problem is witnessed.