FDA Clears iHealthScreen’s AI Diabetic Retinopathy Screening Software

iPredict-DR uses artificial intelligence to analyse retinal images and support earlier detection of diabetic eye disease.

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, developed by New York-based Software as a Medical Device (SaMD) company iHealthScreen, analyses retinal fundus images captured by the iCare DRSplus camera to identify cases of more than mild diabetic retinopathy (mtmDR).

The FDA clearance marks another milestone in the adoption of AI-based medical imaging technologies, with companies increasingly using artificial intelligence to support earlier diagnosis, improve screening capacity and help address healthcare workforce pressures.

How iPredict-DR Detects Diabetic Retinopathy

Diabetic retinopathy is one of the most common complications associated with diabetes and occurs when prolonged high blood sugar levels damage blood vessels in the retina.

The condition can affect people with:

• Type 1 diabetes

• Type 2 diabetes

• Gestational diabetes
  

In its early stages, diabetic retinopathy can be difficult to identify without regular eye examinations.

iPredict-DR uses AI algorithms to assess colour retinal fundus images and detect signs of disease progression.

The software is designed to work with the iCare DRSplus camera, which is already widely used in ophthalmology clinics and optician practices across the US.

By analysing retinal images automatically, the technology aims to support healthcare providers in identifying patients who may require further assessment or referral.

FDA Clearance Based on Clinical Validation

iHealthScreen said the FDA clearance was supported by a clinical validation trial assessing the software’s diagnostic performance, safety and usability.

The company said the approval supports its wider ambition to expand AI-powered retinal screening into primary care and community healthcare settings.

Dr Alauddin Bhuiyan, CEO of iHealthScreen, said the clearance reinforces the company’s goal of improving access to retinal screening and enabling earlier detection of vision-threatening disease.

Following the approval, iHealthScreen is continuing development work on additional AI-based diagnostic applications.

The company is seeking future FDA clearances for technologies focused on detecting:

• Age-related macular degeneration (AMD)

• Glaucoma

• Hypertensive retinopathy

• Cardiovascular disease risk
  

The Growing Need for Diabetic Eye Screening

Diabetic retinopathy remains a significant global healthcare challenge.

The condition is a leading cause of preventable blindness worldwide, but early detection and treatment can help reduce the risk of severe vision loss.

The International Diabetes Federation (IDF) estimates that the global number of people living with diabetes could reach 700 million by 2045.

Despite the importance of regular eye screening, many patients do not complete recommended examinations.

Research from the American Academy of Ophthalmology (AAO) estimates that around six in 10 people with diabetes miss annual screenings that could identify early signs of diabetic retinopathy.

AI-powered screening tools are increasingly being viewed as a potential solution to improve access, particularly in primary care and community settings where specialist ophthalmology resources may be limited.

AI Transforming Medical Imaging

The FDA clearance for iPredict-DR highlights the expanding role of artificial intelligence in healthcare imaging.

AI technologies are being developed across multiple areas of diagnosis, including:

• Eye disease detection

• Cancer imaging

• Cardiovascular risk assessment

• Neurological disease identification
  

Medical imaging has become one of the fastest-growing applications for healthcare AI, with algorithms capable of analysing large volumes of clinical images and identifying patterns that may be difficult to detect through traditional approaches.

According to GlobalData analysis, the healthcare AI market is forecast to reach a valuation of $57.4bn by 2029.

The Future of AI-Powered Eye Diagnostics

The use of AI in ophthalmology continues to expand beyond diabetic retinopathy.

Researchers and healthcare companies are exploring whether retinal imaging can provide insights into a wider range of conditions.

For example, a research team at the University of Edinburgh is developing AI software designed to help optometrists identify potential dementia risk through routine eye examinations.

As healthcare systems look for scalable approaches to early disease detection, AI-powered retinal screening could become an increasingly important tool in expanding access to preventative care.

What iHealthScreen’s FDA Clearance Means for Digital Health

The approval of iPredict-DR represents another step towards integrating AI-powered diagnostics into everyday healthcare environments.

By combining retinal imaging hardware with automated analysis software, iHealthScreen aims to make diabetic retinopathy screening faster, more accessible and easier to deploy outside specialist settings.

As diabetes rates continue to rise globally, technologies that support earlier detection and intervention could play an increasingly important role in preventing avoidable vision loss.

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