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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears iHealthScreen's iPredict-DR AI Software for Diabetic Retinopathy Screening

The 510(k) clearance pairs the software with one retinal camera, iCare's DRSplus, and rests on an 871-subject pivotal study summarized by the FDA.

By News DeskJuly 9, 20262 min read
Photograph of the back of the eye showing small blood vessel changes of diabetic retinopathy
A fundus photograph showing background diabetic retinopathy, from the National Eye Institute. Not an image produced by iPredict-DR. National Eye Institute, National Institutes of Health, Public domain, via Wikimedia Commons · Public domain
FDA cleared510(k) · K253704FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared iPredict-DR under 510(k) K253704, finding it substantially equivalent to the IDx-DR system.
  • The software flags more than mild diabetic retinopathy in adults with diabetes who have not previously been diagnosed with the eye disease.
  • In the pivotal study summarized by the FDA, the software showed 85.58% sensitivity and 91.77% specificity.

The U.S. Food and Drug Administration has cleared iPredict-DR, artificial intelligence software from Richmond Hill, New York-based iHealthScreen that screens retinal photographs for diabetic retinopathy, according to the agency's 510(k) decision letter and summary for submission K253704. The letter is dated July 2, 2026, and the company announced the clearance this week.

The FDA found iPredict-DR substantially equivalent to a predicate device, the IDx-DR retinal image analysis system (K203629). The software is a Class II device under the regulation for retinal diagnostic software devices and is restricted to prescription use.

What the clearance covers

According to the FDA summary, iPredict-DR is intended for use by healthcare providers "to automatically detect more than mild diabetic retinopathy in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy." The clearance is tied to a single camera: the software is indicated for use with iCare's DRSPlus color fundus camera.

The software returns one of two results for each patient, "mtmDR detected" or "mtmDR not detected," where mtmDR stands for more than mild diabetic retinopathy. The FDA summary says the user manual is written for healthcare providers at primary care or endocrinology clinics.

PharmaShots, in a July 9 summary of the company's announcement, reported that iPredict-DR is commercially available across the U.S. and that iHealthScreen is developing the software for age-related macular degeneration, glaucoma, hypertensive retinopathy and cardiovascular disease risk. None of those uses is part of this clearance.

The pivotal study

The FDA summary describes a prospective pivotal trial that enrolled 922 participants, of whom 886 completed the study procedures and 871 were included in the primary analysis. Photos of each participant's undilated eyes were taken with the DRSPlus camera. For comparison, dilated photographs and optical coherence tomography images were graded by three masked expert graders at the Wisconsin Reading Center using the ETDRS severity scale.

Against that reference standard, the software showed sensitivity of 85.58% and specificity of 91.77%, according to the summary. Its positive predictive value was 77.31% and its negative predictive value was 95.10%. About a quarter of subjects in the analysis, 24.68%, had more than mild retinopathy by the reference standard. The software produced a usable result for 99.08% of subjects.

The study population had a median age of 64, and 843 of the 886 participants had type 2 diabetes, according to the summary. The FDA document also describes a separate precision study of 50 subjects in which retinal photos were repeated by three different operators on two units of the same camera model.

Same use, different camera

The FDA summary says iPredict-DR has the same intended use and indications for use as IDx-DR, which is indicated for use with the Topcon NW400 retinal camera. The comparison table lists a different camera for each system and states that the clinical performance data support the use of iPredict-DR with its indicated camera.

The decision letter notes that a 510(k) clearance allows the company to market the device subject to the FDA's general controls, and that changes to the device may require a new submission.

Sources

  1. 510(k) decision letter and summary, K253704 (iPredict-DR), U.S. Food and Drug Administration, July 2, 2026
  2. iHealthScreen Reports FDA Clearance of iPredict-DR for Diabetic Retinopathy Screening, PharmaShots, July 9, 2026