FDA clears iHealthScreen's AI diabetic retinopathy screening software

iHealthScreen received FDA clearance for iPredict-DR, an AI-based software that detects diabetic retinopathy from retinal images captured by widely-used iCare DRSplus cameras in optometry clinics. The company plans to pursue additional clearances for AMD, glaucoma, hypertensive retinopathy, and cardiovascular disease screening. If you build AI for eye imaging or disease detection from retinal scans, you now have a live FDA pathway and a competitor with cleared software. iHealthScreen has de-risked the regulatory route and proven the hardware (iCare cameras) will work with AI software — that's your market definition and your go-to-market route.