iHealthScreen Inc. Announces FDA 510K Submission for iPredict™ AMD tool – An Automated AI-based Software as a Medical Device for Early Diagnosis of Age-Related Macular Degeneration (AMD)

iHealthScreen is the first company to apply for an FDA 510K clearance for screening AMD, which is a leading cause of blindness in the developed world

NEW YORK, May 23, 2023--(BUSINESS WIRE)--iPredictTM AI Eye Screening System provides fully automated age-related macular degeneration (AMD) screening, including retinal imaging and immediate reporting of actionable results. Using the iPredictTM System, primary care and various specialty practices can accurately and efficiently screen people over 50 for AMD and refer them to a specialist (i.e., an ophthalmologist).

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.

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:

iPredict-AMD is indicated for use by health care providers to automatically detect more than early age-related macular degeneration (mteAMD) in adults above 50 years of age who have not been previously diagnosed with Late AMD (i.e., not legally blind or not showing blind spots in their visual field).

iPredict-AMD is indicated for use with the DRSPlus color fundus camera (iCare Inc. K192113) in both primary care and eye care settings.

If referable stage disease is detected for any of these conditions, the iPredict automated report recommends a visit to an Ophthalmologist for appropriate treatment. Otherwise, in accordance with standards of care, a follow-up visit in one year is suggested.