The iPredict AI Eye Screening System will provide a fully automated age-related macular degeneration (AMD) screening report in less than 60 seconds.
iHealthScreen has submitted an application for an FDA 510K clearance for the iPredictTM AI Eye Screening System, which provides fully automated age-related macular degeneration (AMD) screening. The screening includes retinal imaging and immediate reporting of actionable results, providing an easier path to accurately and efficiently screen people over 50 for AMD.
Once high-resolution images of the patient’s eyes have been captured using a color fundus camera and submitted to the iPredictTM AI System, the screening results are available in a fully automated report in less than 60 seconds. The entire test can easily and reliably be completed within 5 minutes.
iHealthScreen conducted a prospective trial in the general population to prospectively assess the product’s accuracy, sensitivity, and specificity. The completed pivotal trial of the device demonstrated that iPredict-AMD achieved excellent accuracy with a sensitivity of 86.86% and a specificity of 94.13%.
These prospective study results were initially presented at the Annual Meeting of the American Academy of Ophthalmology (AAO) and selected for Panel Discussion as outstanding work.
In its 510(k) application to the FDA iHealthScreen has proposed the following indication for iPredict’s use:
“This technology could be particularly useful in identifying someone who has slipped across the boundary for progression into severe AMD,” Theodore Smith, MD, PhD, Professor in Ophthalmology and Neuroscience at Icahn School of Medicine at Mount Sinai, New York said in the press release.
“This is a major milestone for iHealthScreen. iPredictTM eye disease diagnostic tools can help prevent blindness for millions of people and save insurers countless millions of dollars in avoidable healthcare cost,” said Alauddin Bhuiyan, PhD, the founder and CEO of the company in the press release.