iPredict Eye Screening

by iHealthScreen  · Based in United States → — AI-powered screening tools for early detection of retinal and systemic diseases.
Family Medicine Internal Medicine Ophthalmology

Contact for pricing
Regulatory Status Disclosed

Overview

iHealthScreen harnesses artificial intelligence and retinal imaging to provide a HIPAA-compliant platform for the early diagnosis of various eye and systemic diseases. The company’s flagship product, iPredict, offers automated screening for Age-Related Macular Degeneration (AMD), Diabetic Retinopathy (DR), and Glaucoma in primary care settings. Beyond ophthalmic conditions, iHealthScreen also provides an online risk prediction system for systemic diseases such as diabetes, stroke, and heart attack. The technology aims to prevent blindness and save lives by making screening accessible and affordable, delivering fast and accurate results in minutes. iHealthScreen also offers Electronic Health Record (EHR) solutions and AI-based telemedicine services to streamline healthcare delivery and improve patient outcomes.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-Based Screening for Diabetic Retinopathy (DR), Age-related Macular Degeneration (AMD), and Glaucoma
  • Electronic Health Record (EHR) Solutions
  • AI-Based Telemedicine Service
  • Image Analyzer for Retinal Vessel, Retinal Pathology, and OCT Inspector
  • Online Health Risk Prediction System for Diabetic, Stroke, and Heart Attack patients
  • Fast results: test completed in less than 5 minutes, report in under 60 seconds
  • High accuracy: approximately 95% on average (AMD sensitivity 86.86%, specificity 94.13%)
  • Easy to operate, non-invasive, with an advanced touchscreen interface
  • Accessible for use in primary care settings
  • Digital Prescription capabilities integrated within EHR

Use Cases

  • Early screening and diagnosis of Age-Related Macular Degeneration (AMD)
  • Early screening and diagnosis of Diabetic Retinopathy (DR)
  • Early screening and diagnosis of Glaucoma
  • Prediction of risk for stroke and heart attack
  • Telemedicine consultations and remote patient care
  • Retinal image analysis for various pathologies

Details

Category Cardiology AI, Neurology AI, Ophthalmology AI
Pricing Contact for pricing
  • Per patient screening on a Software as a Service (SaaS) model, estimated $10-$20 per patient (20%-40% of Medicare/commercial payor reimbursement)
DeploymentCloud-based (Software as a Medical Device), accessible in primary care settings, clinics, hospitals, and online for telemedicine and prediction apps.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

FDA 510(k) cleared for age-related macular degeneration (AMD) in patients aged 50 years and older (K231454, cleared June 2023). FDA 510(k) submitted for Diabetic Retinopathy (DR) with clearance expected by mid-2025. The system is also CE Certified in Europe, UK, Australia, and UAE for AMD, DR, and Glaucoma screening.

Integrations
EHR Not specified
Specialties Family Medicine, Internal Medicine, Ophthalmology

What the Web Says

iPredict Eye Screening, developed by iHealthScreen, is an AI-powered, cloud-based software that screens for diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucoma using retinal color fundus images. It aims to provide early diagnosis and facilitate timely referrals, particularly in primary care settings. The system is designed to be fast, accurate, and easy to operate, with reports generated in less than a minute and the entire test completed within five minutes.

Overall: Positive

Strengths

  • Early detection and diagnosis of DR, AMD, and glaucoma, potentially preventing blindness.
  • Fast and efficient screening process, with results in under a minute and the full test in under five minutes.
  • Can be integrated into primary care practices, increasing accessibility to eye screenings.
  • Minimally invasive and easy to operate, requiring less than an hour of training for staff.
  • High accuracy rates reported for detecting various eye conditions.
  • Received CE certification, TGA approval (Australia), MHRA approval (UK), and US patents for AMD and glaucoma detection, with FDA 510(k) clearance for iPredict-DR.

Limitations

  • Further future studies are required to assess the impact and efficacy of the system, especially regarding report quality in the presence of media opacities like cataracts.
  • While the model is not designed to detect diseases other than AMD, it has identified some concomitant diseases, which could be an added benefit but also highlights a potential limitation in its specific diagnostic scope.
  • Some Reddit discussions about eye screening photos in general mention potential concerns about optional charges and whether they replace traditional dilation, suggesting a need for clear communication on benefits and insurance coverage.
  • One Reddit thread discusses AI eye scans for predicting cognitive decline and dementia, which, while a positive use of AI, is a different application than iPredict's primary focus on DR, AMD, and glaucoma, indicating a broader landscape of AI in ophthalmology that iPredict currently doesn't cover.

Based on reviews from: Health Technology Review, Optometry Times, iHealthScreen receives US patent for iPredict glaucoma detection model, iPredict-DR Automated Diabetic Retinopathy Screening Tool to Help Prevent Blindness, A prospective study for validating an automated AI-based system for detecting age-related macular degeneration in clinical settings - PMC, iHealthScreen submits AI-based AMD screening tool to FDA for 510(k) clearance, iHealthScreen Inc. applies for FDA 510K Submission for iPredictu2122, an AI-based, software as a medical device tool to diagnosis AMD | Eye Care Network - Modern Retina - Ophthalmology Times, iHealthScreen Website, Study Details | NCT07084883 | Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration, AI-powered AMD screening tool receives FDA clearance - Healio, A scoping review of artificial intelligence as a medical device for ophthalmic image analysis in Europe, Australia and America - PMC, An Artificial-Intelligence- and Telemedicine-Based Screening Tool to Identify Glaucoma Suspects from Color Fundus Imaging - PMC, IHealthScreen nabs FDA nod for AI-backed dx to spot mild diabetic retinopathy, Fully Automated Software for Glaucoma Screening iPredictu2122 which utilizes retinal color fundus image and AI based tool - iHealthScreen, FDA clears iHealthScreen's AI diabetic retinopathy screening software, Breakthrough AI-powered eye scan predicts risk of cognitive decline and dementia - The Brighter Side of News - Reddit, iHealthScreen Receives U.S. FDA 510(k) Clearance (K253704) for iPredict-DR, an AI-Powered Software for Automated Diabetic Retinopathy Screening - Business Wire, Researchers have found that artificial intelligence (AI) can help identify serious lung and heart complications in premature infants by analyzing images already collected during routine eye screenings. : r/science - Reddit, AI tool can scan your retina and predict your risk of heart disease 'in 60 seconds or less', School's eye screener test detected eye issue in kindergartner despite passing standard eye test at pediatrician : r/kindergarten - Reddit, Yearly Eye Exam - they want to charge me $40 for 'Eye Screening Photo' - Legit? - Reddit

Last updated: 2026-08-13

Ratings & Reviews

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Press & Coverage

Business Wire
iHealthScreen Receives U.S. FDA 510(k) Clearance (K253704) for iPredict-DR, an AI-Powered Software for Automated Diabetic Retinopathy Screening
iHealthScreen announced FDA 510(k) clearance for iPredict-DR, an AI-powered software that automatically detects more than mild diabetic retinopathy in adults with diabetes. This clearance is a significant milestone for the company, aiming to make AI-powered retinal screening accessible in primary care.
2026-07
Fierce Biotech
IHealthScreen nabs FDA nod for AI-backed dx to spot mild diabetic retinopathy
iHealthScreen received FDA 510(k) clearance for its AI-powered diagnostic that detects mild diabetic retinopathy in adults with diabetes. The iPredict-DR system is non-invasive and can be used by minimally skilled healthcare workers.
2026-07
Medical Device Network
FDA clears iHealthScreen's AI diabetic retinopathy screening software
iHealthScreen obtained US FDA clearance for iPredict-DR, an AI-based screening software for diabetic retinopathy, which analyzes color retinal fundus images. The company is also pursuing additional FDA clearances for age-related macular degeneration, glaucoma, hypertensive retinopathy, and cardiovascular disease risk.
2026-07
Optometry Times
iHealthScreen awarded US patent for iPredict glaucoma detection model | Optometry Times
iHealthScreen Inc. was awarded a US patent for its iPredict glaucoma detection model, which uses AI and color fundus imaging. This makes them the first company to receive two US patents for AMD and glaucoma screenings.
2024-04
Business Wire
iHealthScreen Inc. Announces UK Medicines and Healthcare Products Regulatory Agency (MHRA) Certification and registration for iPredictu2122 - Automated AI System for Early Diagnosis of DR, AMD, and Glaucoma
iHealthScreen announced MHRA certification and registration for its iPredictu2122 AI Eye Screening System, providing automated screening for diabetic retinopathy, age-related macular degeneration, and glaucoma. The system is already in use in Australia, UAE, and Bangladesh.
2023-12
Healio
AI-powered AMD screening tool receives FDA clearance - Healio
iHealthScreen's iPredict Eye Screening System, an AI-powered tool for age-related macular degeneration (AMD) in patients 50 and older, received FDA 510(k) clearance. The system provides screening results within 60 seconds.
2023-06
Medical Device News by Guided Solutions
iHealthScreen receives FDA 510(k) for AI-enabled eye screening ...
iHealthScreen received FDA 510(k) clearance for its iPredict Eye Screening System, an AI-enabled software for retinal imaging. This system leverages AI to screen for eye conditions.
2023-05
iHealthScreen
iHealthScreen Seeks FDA Approval for AI-Powered AMD Tool
iHealthScreen submitted for FDA 510(k) clearance for iPredict, aiming to be the first company to seek FDA approval for screening Age-Related Macular Degeneration (AMD). The iPredict AI Eye Screening System offers a comprehensive solution for AMD screening with immediate results.
2023-05

Videos

Product demos, reviews, and walkthroughs for iPredict Eye Screening.

View all on YouTube

Frequently Asked Questions

iPredict integrates by having a trained medical assistant capture high-resolution retinal images using a color fundus camera, which are then uploaded to the cloud-based system for AI analysis. The system provides an automated report in under 60 seconds, with the entire test completed in less than five minutes. Technical requirements include an FDA-approved color fundus camera, such as the DRSPlus, and a validated web-based platform accessible via standard browsers for image submission and report viewing.
iPredict has received CE certification in Europe, approval from Australia's Therapeutic Goods Administration (TGA), and Abu Dhabi Health approval for detecting AMD, DR, and glaucoma suspect. It also obtained FDA 510(k) clearance in June 2023 for screening age-related macular degeneration (AMD) in adults aged 50 and older. iHealthScreen states that iPredict is a HIPAA-compliant software product, designed for secure handling of patient data.
iPredict offers high efficiency, delivering automated reports in under 60 seconds and completing the entire test in less than five minutes, which is faster than traditional teleretinal screenings relying on human readers. For AMD, it boasts a sensitivity of 86.86% and specificity of 94.13%, while for DR, it shows 86.9% sensitivity and 94.1% specificity. The system aims for cost-effectiveness through early detection and prevention of advanced disease, supported by CPT code 92229 for AI-based retinal imaging.
While specific pricing details are not explicitly stated, iHealthScreen emphasizes providing 'low-cost, advanced screening software' and is actively raising capital. The availability of CPT code 92229 for automated AI analysis of retinal images provides a clear reimbursement pathway, which is a significant factor for a practice's return on investment. The system's ability to facilitate early detection and potentially prevent blindness can lead to substantial savings in avoidable healthcare costs, contributing to a positive ROI.
iPredict is indicated for the automatic detection of diabetic retinopathy, age-related macular degeneration, and glaucoma suspect, with its FDA clearance specifically for AMD in adults over 50. A noted limitation is its specificity as a disease reporting tool, which may pose challenges in patients with multiple pathologies. Further studies are also recommended to assess its efficacy, particularly regarding report quality in the presence of media opacities like cataracts.
Clinical evidence for iPredict includes a pivotal prospective trial for AMD, demonstrating a sensitivity of 86.86% and a specificity of 94.13%. For diabetic retinopathy screening, a prospective trial showed 86.9% sensitivity and 94.1% specificity. The glaucoma detection model has achieved an accuracy of 89.67%, with 83.33% sensitivity and 93.89% specificity.
Physicians remain ultimately responsible for patient care decisions, even when utilizing AI tools like iPredict. If a physician follows an AI-suggested diagnosis without applying independent clinical judgment, they remain liable for the outcome. Most AI vendors limit their liability, placing the legal risk primarily on the healthcare provider, emphasizing the need for critical clinical oversight.

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Suggest an Edit → | Last Verified: 2026-05-13 | First Added: 2026-05-13
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