Yesterday, the FDA cleared for marketing a product called IDx-DR, the first medical device that uses artificial intelligence (AI) to detect “greater than mild” diabetic retinopathy (DR) in adults with diabetes. It is marketed by privately owned start-up venture IDx, LLC, of Coralville, Iowa.
An FDA release says IDx-DR “provides a screening decision without the need for a clinician to also interpret the image or results, which makes it usable by health care providers who may not normally be involved in eye care.”
The system uses an AI algorithm to analyze images taken with a Topcon NW400 retinal camera and uploaded to a cloud server. The software then provides one of two results: (1) “more than mild diabetic retinopathy detected: refer to an eye care professional” or (2) “negative for more than mild diabetic retinopathy; rescreen in 12 months.”
As part of the decision, the FDA evaluated data from a clinical study of retinal images obtained from 900 patients with diabetes at 10 primary care sites. In the study, IDx-DR correctly identified the presence of more than mild diabetic retinopathy 87.4% of the time and correctly identified those who did not have more than mild diabetic retinopathy 89.5% of the time.
The approval comes with contraindications, however. Patients who shouldn’t be screened with the device include those with a history of laser treatment, surgery or injections in the eye or who have persistent vision loss, blurred vision, floaters, previously diagnosed macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion. Other contraindications include patients with diabetes who are pregnant.
|US Food and Drug Administration. FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604357.htm. April 11, 2018. Accessed April 12, 2018.|