World’s first CE-certified AI retinal-screening tool

July 3, 2023 Staff reporters

iPredict, an automated artificial intelligence (AI) retinal screening system, has received CE certification and Australian approval for early detection of age-related macular degeneration (AMD), diabetic retinopathy (DR) and glaucoma. The system can also screen and refer individuals at risk of developing cardiovascular heart disease and stroke, said iHealthScreen, the US company behind iPredict.  


A prospective trial of iPredict demonstrated a sensitivity of 86.86% and a specificity of 94.13% in detecting more-than-early AMD (mteAMD) in adults above 50 years of age from colour fundus images, the company reported, adding the entire test can be completed within five minutes. “This technology could be particularly useful in identifying someone who has slipped across the boundary for progression into severe AMD,” said Dr Theodore Smith, professor of ophthalmology and neuroscience at Icahn School of Medicine at Mount Sinai, New York. 


iHealthScreen said it has also received UAE approval for iPredict’s use in AMD, DR and glaucoma screening, while it expects US Food and Drug Administration approval for AMD and DR screening in the third quarter of 2023. 


iPredict is one of several emerging AI screening systems. Closer to home, a multicentre trial of Kiwi company Toku Eyes’ product Theia showed it did not miss any referable cases and had an overall accuracy of 98% when screening for ‘more-than-mild DR’ and sight-threatening disease.