FDA News

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,” Jonathan Stevenson, vice president and chief information officer at IRIS, 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.

Ingrid Zimmer-Galler, MD, board member, American Telemedicine Association, said in the release, “IRIS has delivered a major step forward in the global advancement of telemedicine technology, and is yet another validation of a system with the potential to significantly expand access for the millions of patients with diabetes who fail to receive annual retinal assessments.”

Disclosures: Stevenson is vice president and chief information officer at IRIS. Zimmer-Galler reports no relevant financial disclosures.

Editor's Note: On April 13, we corrected the quotes within this article to clarify the sources. The Editors regret this error.

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,” Jonathan Stevenson, vice president and chief information officer at IRIS, 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.

Ingrid Zimmer-Galler, MD, board member, American Telemedicine Association, said in the release, “IRIS has delivered a major step forward in the global advancement of telemedicine technology, and is yet another validation of a system with the potential to significantly expand access for the millions of patients with diabetes who fail to receive annual retinal assessments.”

Disclosures: Stevenson is vice president and chief information officer at IRIS. Zimmer-Galler reports no relevant financial disclosures.

Editor's Note: On April 13, we corrected the quotes within this article to clarify the sources. The Editors regret this error.