Remidio Innovative Solutions, a Bengaluru based med-tech innovator, has announced that its Medios HI Glaucoma AI and Medios HI DR AI have received CE Marking as Class II Software as a Medical Device (SaMD) under the EU Medical Device Regulation (MDR).

The CE Approval marks a major milestone for Remidio, validating its  offline AI that can simultaneously detect diabetic retinopathy and glaucoma from a single retinal image. Delivering results in under 10 seconds without internet connectivity or cloud inferencing.

With this achievement, Remidio strengthens its position as India’s only CDSCO-approved ophthalmic AI company and a leader in making advanced eye screening more accessible and affordable.

As the burden grows, a shortage of specialists limits timely screening. For the first time, a powerful offline AI-based tool can help bridge this gap bringing early detection to the point of care and protecting millions from avoidable vision loss.

Remidio’s Medios HI Glaucoma AI goes beyond traditional screening methods. Instead of relying solely on the cup-to-disc ratio, it analyzes structural changes in the optic nerve head and retinal nerve fiber layer, similar to assessments done by specialists using high-end imaging tools.

The AI also uses Class Activation Maps (CAMs) to highlight regions of interest, helping doctors quickly identify potential signs of glaucoma.

To ensure its accuracy for global use, the AI was validated on over 100,000 real-world images, including data from diverse populations across India and Europe.