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iHealthScreen submits AI-based AMD screening tool to FDA for 510(k) clearance

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3 min read

iHealthScreen Inc. announced it has submitted 510(k) clearance to the FDA for the iPredict Artificial Intelligence (AI) Screening System for age-related macular degeneration (AMD).

Refresh me on iHealthScreen.

Founded in 2015, iHealthScreen is focused on developing novel, innovative software for eye- and systemic-disease screening and prediction services. In the ophthalmic space, the company is targeting retinal image grading as well as early-stage screening and diagnosis of ocular diseases such as AMD, glaucoma, and diabetic retinopathy (DR).

Now talk about the iPredict.

The screening system is designed to provide a fully automated screening for AMD via retinal imaging for instant results in a clinical setting.

Exactly how fast is this process?

High-resolution images of the eye with a color fundus camera are captured before submitting to the iPredict system, which then provides screening results in a fully-automated report in under 1 minute.

According to the company, the entire test can be completed within 5 minutes.

Then what?

If the system detects a referable disease, the report provides an ophthalmologist-visit recommendation for treatment; if no disease is detected, a 1-year follow-up visit is recommended.

Any clinical data on it?

Yes! A prospective trial (NCT05324189) evaluated the use of the screening system among the general population (n = 1,000; 18+ years of age) for accuracy, sensitivity, and specificity in early diagnosis for DR.

Results thus far have found that iPredict demonstrated 86.9% sensitivity and 94.1% specificity.

According to Clinical Trials, the study is slated to conclude by December 2024.

See here for additional research.

What does this 501(k) application include?

The application includes proposals to indicate the iPredict system for the following:

  • For use by healthcare providers (HCPs) to automatically detect more-than-early-stage AMD (mteAMD) in adults 50+ years of age with no previous late AMD diagnosis.
  • For use with the DRSPlus color fundus camera (iCare USA Inc.) in both primary and eye care settings.

What should I know?

The system received CE certification in 2021 for detecting mild and non-proliferative DR, proliferative and diabetic macular edema (DME), as well as glaucoma suspects based on abnormal optic discs and in patients over the age of 50 for AMD.

And outside of the U.S., the iPredict was approved in 2022 by the Australian Health Therapeutics goods Administration—the equivalent to the FDA.

So what’s next?

The FDA has 90 days to make a medical device user fee amendments (MDUFA) decision for pre-market approval.

Significance?

iHealthScreen is now the first company to apply for FDA clearance in AMD screening.