FDA Clears AI-Powered Diabetic Retinopathy Screening Software from iHealthScreen

The AI-powered software analyses retinal images captured by the widely used iCare DRSplus camera, supporting earlier detection of diabetic retinopathy in primary care and community healthcare settings.

iHealthScreen has received US Food and Drug Administration (FDA) clearance for iPredict-DR, an artificial intelligence (AI)-powered screening software designed to detect diabetic retinopathy in adults with diabetes.

The software analyses colour retinal fundus images captured using the iCare DRSplus camera to identify more than mild diabetic retinopathy (mtmDR), one of the leading causes of preventable blindness worldwide.

AI Supports Earlier Disease Detection

iPredict-DR has been developed as a Software as a Medical Device (SaMD) and uses AI algorithms to analyse retinal images without requiring manual interpretation during the initial screening process.

The software is intended to help healthcare professionals identify patients who require further ophthalmic assessment, enabling earlier referral and intervention.

The FDA clearance was supported by a clinical validation study evaluating the software's diagnostic performance, safety and usability.

Addressing a Growing Healthcare Challenge

Diabetic retinopathy is a common complication of diabetes caused by prolonged high blood sugar levels damaging blood vessels in the retina.

If left undiagnosed and untreated, the condition can lead to progressive vision loss and blindness.

According to the International Diabetes Federation, the global number of people living with diabetes is expected to reach 700 million by 2045, increasing demand for scalable screening solutions.

Despite recommendations for annual eye examinations, studies from the American Academy of Ophthalmology suggest that approximately 60% of people with diabetes miss their yearly retinal screening appointments, creating opportunities for disease progression before diagnosis.

Expanding the AI Eye Screening Platform

Following the FDA clearance, iHealthScreen plans to expand its AI platform into additional ophthalmic and systemic diseases.

The company is pursuing further regulatory clearances for software designed to detect:

• Age-related macular degeneration (AMD)

• Glaucoma

• Hypertensive retinopathy

• Cardiovascular disease risk
  

CEO Dr Alauddin Bhuiyan said the approval supports the company's goal of making AI-powered retinal screening more widely available in primary care and community healthcare settings to enable earlier diagnosis and referral.

AI Continues to Transform Medical Imaging

The clearance reflects the growing adoption of artificial intelligence across medical imaging and diagnostic workflows.

AI technologies are increasingly being used to improve disease detection, reduce diagnostic workloads and expand access to specialist screening services.

Market forecasts suggest the global AI in healthcare sector will continue to grow rapidly over the coming years, while researchers are also exploring additional ophthalmic AI applications, including software capable of identifying dementia risk through routine eye examinations.

Why the Clearance Matters

The FDA decision highlights several broader trends shaping digital healthcare:

• AI-powered screening tools are becoming increasingly integrated into routine clinical practice.

• Earlier detection of diabetic retinopathy could help reduce preventable vision loss.

• Software as a Medical Device continues to expand across ophthalmology and diagnostic imaging.

• Retinal imaging is emerging as a valuable platform for identifying both eye disease and wider systemic health conditions.
  

Summary

The FDA has cleared iHealthScreen's AI-powered iPredict-DR software to screen adults with diabetes for more than mild diabetic retinopathy using retinal images captured by the iCare DRSplus camera.

The approval expands the use of AI in ophthalmology and supports earlier detection of one of the leading causes of preventable blindness, while laying the groundwork for future AI-based screening tools targeting additional eye and systemic diseases.

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