FDA approves first teleretinal screening system

The U.S. FDA has cleared retinal screening software for use in a telemedicine platform to screen for diabetic retinopathy, macular edema, glaucoma and other suspected conditions.

Called Intelligent Retinal Imaging Systems (IRIS), the screening service is run and supervised by retina specialtists. The company says non-physicians can be trained to use the non-mydriatic fundus camera to screen most patients in less than 15 minutes.

The digital images are then enhanced and sent instantly to a screening specialist using secure cloud computing. IRIS technology detects and screens for potential pathology and indicates any areas of concern for the screening specialist to review. IRIS says the system has a sensitivity rate of 97% and that it is continuously refining its algorithms.

IRIS says its integrated grading module follows American Academy of Ophthalmology classification criteria, allowing real-time reading and classification of the image.

The platform also allows any healthcare professional to generate a detailed patient report that can then be printed or e-mailed for easy referral to a specialist.  A copy of the report is given to the patient and emailed to the primary care doctor. The physician is then referred to a board-certified retina specialist in the region.

“The recent FDA clearance underscores just how unique our service is,” said IRIS CEO Jason Crawford. “Healthcare providers and payers across the country who are seeking to improve their quality scores – r specifically increasing their screening rates for diabetic retinopathy – can rely on the expertise of our team to guide them through the process.”