The US Food & Drug Administration (FDA) has just delivered its first authorisation for AI-based equipment to make an autonomous medical diagnosis without the intervention of a doctor.
IDx-DR software, which can diagnose diabetic retinopathy by analysing retinal images of patients, has just been approved by the FDA. This authorisation is the first of its kind for artificial intelligence, and should mean that this severe diabetes-related condition, caused by the blood vessels in the retina being affected and which can lead to blindness, can be better taken care of. The disease affects 50% of people suffering from type 2 diabetes in France according to the French Diabetic Federation and is the leading cause of blindness among the under-65s, says website Frenchweb.fr.
Better access to testing for diabetic retinopathy
According to an official press release from the FDA, IDx-DR is "the first piece of equipment authorised for commercial sale which provides a decision on a test without a clinical practitioner also having to interpret the image or the results, meaning that it can be used by health professionals who are usually not involved in eye care". The software can therefore be used by nurses and doctors trained in other fields.
The new equipment should make it easier to test diabetic patients, of whom only 50% consult an eye doctor at least once a year according to the FDA, who will "continue to work towards easier access to safe and efficient digital health possibilities which could improve patients’ access to the health care they need".
Correct diagnosis in 89.5% of cases
The IDx-DR has been tested as part of a clinical study on retinal images from 900 diabetic patients in 10 health centres, and in 87.5% of cases, diabetic retinopathy was correctly diagnosed. The software was able to detect patients who were not affected in 89.5% of cases.
Retinal photos, which need to be taken using a specific piece of equipment, are downloaded by the software which first of all determines if their quality is sufficient for a correct analysis, before being transmitted to a server where they are processed by the artificial intelligence in IDx-DR. If the diagnosis is negative, the patient can wait for up to a year before having another test, otherwise they will be put in touch with a specialist.
It should be noted that the FDA has nevertheless laid down certain restrictions. The equipment is not authorised for use on pregnant women, patients having undergone laser surgery or those suffering from blurred or a persistent loss of vision. It should also notreplace the full sight tests that need to be carried out at the ages of 40 and 60.
However, FDA approval for IDx-DR still represents an important new chapter in the use of artificial intelligence in the medical domain, with other advances in ophthalmology no doubt just around the corner, particularly since Google is currently training its "DeepMind" IA to detect eye disease.
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