FDA approves primary care AI imaging device to detect eye disease in diabetics

Primary care physicians may now be able to identify moderate to severe levels of retinopathy in adult patients with diabetes with a recently FDA-approved artificial intelligence (AI) imaging device.

According to an April 11 release, the AI imaging device, called IDx-DR, provides a screening decision without the need for a clinician to also interpret the image and results. 

Diabetic retinopathy is the most common cause of vision loss, vision impairment and blindness among the more than 30 million Americans living with diabetes. 

With IDx-DR, primary care physicians can analyze images of the patient's eye taken with a retinal camera upload the images onto the cloud server which IDx-DR is installed on and. If the images are sufficient in quality, they can suggest preventative treatment options or make a diagnosis.  

“Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50 percent of them do not see their eye doctor on a yearly basis,” said Malvina Eydelman, MD, director of the division of ophthalmic and ear, nose and throat devices at the FDA's Center for Devices and Radiological Health, in a prepared statement. “Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office.” 

Retinal images from 900 patients with diabetes at 10 primary care sites were evaluated by the FDA prefacing the approval of IDx-DR. In the study intended to evaluate the accuracy of IDx-DR in detecting patients with more than mild diabetic retinopathy, the device identified patients with more than mild diabetic retinopathy 87.4 percent of the time and those without 89.5 percent of the time, according the press release.  

In addition to its approval, the FDA strongly advises that patients who have the following conditions or medical history should not be screened with IDx-DR: 

  • Medical history of laser treatment, surgery or injections in the eye.  
  •  Persistent vision loss, blurred vision, floaters, previously diagnosed macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion. 
  • Patients with diabetes who are pregnant.