Diabetic Retinopathy AI Screening System RetinaScan: Screening Available at the Optician

RetinaScan, the AI screening system released by US digital diagnostics company Digital Diagnostics, has been deployed at 5,800 optical stores and pharmacy chains across the US. Using a portable fundus camera and cloud-based AI analysis, the system completes diabetic retinopathy screening within 90 seconds at 94.7 percent accuracy.

Diabetic retinopathy, sometimes called DR, is one of the most common complications of diabetes and the leading cause of blindness in working-age people. The US has more than 37 million people living with diabetes, but only about half of them get an annual eye exam as recommended by the American Diabetes Association. The main reason is that specialist visits require appointments with ophthalmologists, with long wait times and high cost.

RetinaScan's choice of optical stores and pharmacies as deployment sites is designed to break that barrier. Users can walk into any deployment site, book a simple appointment, and complete the screening within 90 seconds. The procedure does not require pupil dilation and uses a new non-mydriatic fundus camera to capture clear retinal images.

Once the image is uploaded to the cloud, the AI model begins analysis immediately. The model is trained on a dataset of 2.2 million annotated fundus images and can identify early, intermediate, and late-stage DR lesions. The system generates a screening report right away, and if abnormalities are found, users can book a specialist ophthalmologist directly through the system.

On the business model, Digital Diagnostics partners with optical chains LensCrafters and Target Optical and pharmacy chains CVS and Walgreens to deploy the devices. Screening costs are covered by insurance, and uninsured users can pay 49 dollars out of pocket. Company CEO John Bertrand said the distribution network makes screening 60 percent cheaper than traditional routes.

On clinical validation, RetinaScan has been rigorously evaluated in a multi-center study sponsored by the US National Institutes of Health. Results show 94.7 percent sensitivity and 91.3 percent specificity, in close agreement with specialist ophthalmologists. The FDA cleared the system for diabetic retinopathy screening in 2024.

On international expansion, Digital Diagnostics has signed agreements with local partners in India, Brazil, and Mexico. These countries have large diabetic populations but scarce specialist eye care resources, and RetinaScan could meaningfully lift early detection. In India, the company plans to cover 30,000 optical stores within two years.

RetinaScan still has limits. It only identifies a few fundus conditions such as DR and macular degeneration, with limited ability to detect glaucoma and other blinding diseases. John Bertrand said the team is expanding the diagnostic range and aims to support screening for 10 major eye diseases by 2027.

On privacy, RetinaScan image data storage complies with HIPAA. All data transmission is encrypted, and AI analysis runs in an isolated secure environment. The company commits not to use user fundus images for AI model training without explicit consent.