Here’s How the FDA Approval of IDx-DR Will Impact Patients

Here's How the FDA Approval of IDx-DR Will Impact Diabetics

There are currently over 4 million people living with permanent vision loss from diabetes. This is especially sad because, according to the National Institutes of Health, the risk of vision loss from diabetes can be reduced by 95% with regular access to eye care. In this article, I’m going to review what diabetic retinopathy is as well as talk about the recent FDA approval of the artificial intelligence system IDx-DR.

How diabetes damages the eye

The disease associated with vision loss from diabetes is called diabetic retinopathy. It’s a condition that affects the retina, a tissue located inside the eye that is responsible for processing light so you can see. The disease damages the retina by weakening the blood vessels that nourish the tissue. This leads to the leaking of blood and fluid from these vessels into the back of the eye. If untreated, this process can lead to scarring of the retina and causes permanent vision loss.

Fortunately, the condition can be treated with medications available today. But, if it is not diagnosed and treated, permanent vision loss can occur (even to the point of blindness).

This is what diabetic retinopathy looks like.

Using IDx-DR to diagnose diabetes

There are many approaches that are being explored to address the problem of undiagnosed diabetic retinopathy. The most recent of which is the use of artificial intelligence to screen individuals with diabetes for diabetic retinopathy. This process involves computers that are programmed to detect diabetic retinopathy in photos of the back of the eye. Scientists do this by training the computers to identify features of the disease found in thousands of photos.

Recently, the artificial intelligence approach received a large boost with the FDA approval of a system called IDx-DR (listen to a podcast where I interview the company founder here). The system can screen individuals for diabetic retinopathy and accurately diagnose the diseases (without the help of an eye doctor that is specifically trained in retinal disease). This FDA approval is the first of its kind and we can expect to see many more applications of this technology in healthcare in the near future!

Will IDx-DR replace diabetic eye exams?

No. However, the technology can make a big difference today by increasing access to eye care for people with diabetes who currently don’t receive it. It’s estimated that 50% of people with diabetes don’t get their recommended yearly eye exam. IDx-DR is positioned well to help these individuals get a screening for diabetic retinopathy during their routine visits to their primary care doctor. This can provide entry into the eye care system for individuals who are at risk of permanent vision loss from diabetes, but who would not have otherwise seen an eye doctor.

Lastly, as mentioned above, this technology does not replace the need to see an eye doctor. While it has been shown to be effective in diagnosing diabetic retinopathy, it does not evaluate patients for other eye diseases that people with diabetes have a higher risk of developing (i.e. glaucoma, cataracts, etc.). As a result, I highly recommend you continue visiting your eye doctor for routine, comprehensive eye care!