IHealthScreen hauled in FDA 510(k) clearance for its AI-powered diagnostic that detects mild diabetic retinopathy in diabetic adults who have gone undiagnosed with the condition.
The Richmond Hill, New York-based software and medical device company’s iPredict-DR leverages AI to review color retinal fundus images using its iCare DRSplus camera.The system is non-invasive and is easy to use by any minimally skilled healthcare worker or nurse, the company said in a press release.
The platform was designed to meet an unmet global need to address what is a preventable outcome if detected.
“This achievement reinforces our mission to make AI-powered retinal screening accessible in primary care and community healthcare settings, enabling earlier detection, faster referral, and helping prevent avoidable vision loss,” Alauddin Bhuiyan, founder and CEO of iHealthScreen, said in a statement.
The regulatory approval is the first commercial milestone the company hit that is part of its overall plan for AI-powered SaMD (Software as a Medical Device) in retinal imaging.
iHealthScreen, which was founded in 2015, is currently working on FDA clearances for early detection of age-related macular degeneration, glaucoma, hypertensive retinopathy, and cardiovascular disease risk.
With the approval, the iPredict-DR system is commercially available throughout the U.S., the company said.
Last November, Optain Health, which also uses artificial-intelligence-powered retinal screening technology, snapped up EyePACS for an undisclosed price. The deal gave Optain to add EyePACS’ teleophthalmology network and expand access to eye disease screening in primary care.
That deal, executives said, would provide access to early disease detection in the U.S. as well as globally in order to prevent avoidable blindness.