FDA Clearance Sets Retinal Screening Company Apart

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Intelligent Retinal Imaging Systems (IRIS), a retinal screening solution for primary care, has received clearance by the United States Food and Drug Administration (FDA), a distinction that comes after months of self-imposed FDA scrutiny.

Intelligent Retinal Imaging Systems (IRIS), has been cleared by the FDA for retinal screenings in primary care

"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 patients with diabetes." — Ingrid Zimmer-Galler, M.D.

IRIS is the first and only FDA Cleared Class II device indicated for use as a telemedicine platform for screening patients for Diabetic Retinopathy, Macular Edema, Glaucoma and other suspected conditions.

Ingrid Zimmer-Galler, M.D., Associate Professor at Wilmer Eye Institute and board member of American Telemedicine Association stated, "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."

“We are very pleased to announce this major milestone for IRIS,” said Jonathan Stevenson, VP and Chief Information Officer of 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.”

The FDA indications for use statement explains: The IRIS Intelligent Retinal Imaging Systems is a comprehensive web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data and images from computerized diagnostic instruments or systems. Original and color amplified images can be viewed by trained healthcare professionals.

“The recent FDA Clearance underscores just how unique our service is,” said Jason Crawford, CEO of IRIS. “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.”

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