iHealthScreen has announced FDA 510(k) submission for iPredict- AMD tool

iPredict AI Eye Screening System revolutionises the screening process for age-related macular degeneration (AMD) by providing a fully automated solution that includes retinal imaging and instant reporting of actionable results. This innovative system enables primary care physicians and specialists to efficiently and accurately screen individuals over the age of 50 for AMD, facilitating timely referrals to ophthalmologists.

The introduction of iPredictTM marks a significant milestone for iHealthScreen, as its eye disease diagnostic tools have the potential to prevent blindness in millions of people while saving insurers substantial sums of money in avoidable healthcare costs.

The procedure begins with the capture of high-resolution images of the patient's eyes using a colour fundus camera. These images are then submitted to the iPredictTM AI System, which generates a comprehensive and automated report in under 60 seconds. The entire screening process can be completed reliably and easily within just 5 minutes.

To evaluate the accuracy, sensitivity, and specificity of the iPredict-AMD system, iHealthScreen conducted a prospective trial in the general population. The pivotal trial demonstrated outstanding results, with iPredict-AMD achieving an impressive sensitivity of 86.86% and specificity of 94.13%.

If referable stage disease is detected for any of the identified conditions, the iPredict automated report recommends a visit to an ophthalmologist for appropriate treatment. Otherwise, as per standard care guidelines, a follow-up visit in one year is suggested.

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