IDx, a company out of Coralville, Iowa, won FDA de novo clearance to introduce its artificial intelligence-powered IDx-DR diabetic retinopathy detection system. This is the first device cleared in the United States to autonomously diagnose a medical condition without requiring a review by a specially trained clinician.
It’s intended to provide an easy screening option for general practitioners and other doctors that deal with diabetic patients but are not trained in ophthalmic diagnostics. The new capability may drastically increase the number of diabetic people receiving screenings, as many of them don’t visit the ophthalmologist’s often enough.
The system uses a fundus camera to capture two color photos at 45 degree angles of each eye. These images are then transferred to an online server where they are processed and a report returned with a diagnosis. The patient is then sent home or referred to an eye care professional.
The system is already cleared for use in Europe since 2016 and a recent trial that showed its almost 90% ability to spot diabetic retinopathy led to the current FDA clearance.
Product page: IDx-DR…
Via: IDx…