First diabetic retinal screening device receives FDA clearance

Information about IRIS: 

IRIS is the only screening service run and supervised by retina specialists, giving patients and physicians unprecedented access to the highest quality retinal care available.

Diabetic Retinopathy Screenings in Primary Care

  • Diabetic retinopathy is the leading cause of preventable blindness in the United States in people 20 to 65 years of age.
  • The American Academy of Ophthalmology recommends that anyone with diabetes receive a retinal eye exam every year.
  • Early detection can reduce the risk of severe vision loss by 90% and significantly reduce long-term healthcare costs.
  • Unfortunately, fewer than 50% of patients with diabetes get a diabetic eye screening annually.
  • An IRIS retina exam is painless, takes less than 10 minutes to complete, and is administered in a primary care physician’s office.

First diabetic retinal screening device receives FDA clearance

The FDA granted clearance to Intelligent Retinal Imaging Systems, a retinal screening software for primary care, according to a press release.

As a telemedicine platform for screening patients with diabetic retinopathy, macular edema, glaucoma and other potential conditions, Intelligent Retinal Imaging Systems (IRIS) is currently the only FDA cleared Class II device.

“We are very pleased to announce this major milestone for IRIS. FDA Clearance is an important differentiator about our service and underscores our commitment to go above and beyond with our technology. We have worked very hard to build scalable systems that protect patient health information and support our mission to end preventable blindness,” Ingrid Zimmer-Galler, MD,board member, American Telemedicine Association, said in a press release.

The FDA detailed that IRIS will be used for storing, managing and displaying patient data, diagnostic data and images from computerized diagnostic instruments or systems.

Additionally, trained health care professionals will be able to view original and color amplified images on the web-based software system.

IRIS CEO, Jason Crawford, said in a press release, “The recent FDA clearance underscores just how unique out service is. Healthcare providers and payers across the country who are seeking to improve their quality scores — specifically increasing their screening rates for diabetic retinopathy – can rely on the expertise of our team to guide them through the process. We will continue to innovate systems that improve access for patients while decreasing the total cost of care.”

Read more: 

Source: Healio