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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.
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The Wire takeaway
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.
Read the full story at yahoo.com →
Topics: Digital Health · fda-clearance · ai-diagnostics · diabetic-retinopathy · medical-devices · primary-care-screening