Bengaluru, India — 22 October 2025 — Remidio Innovative Solutions, 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.

“Securing CE Marking is not just a regulatory milestone; it validates our mission,” said Dr. Anand Sivaraman, CEO, Remidio. “Detecting two major causes of blindness from the same image makes eye care more efficient, scalable, and accessible.”

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.

The Global and European Burden of Eye Disease

• Diabetes:More than 420 million people worldwide live with diabetes; up to 1 in 3 will develop diabetic retinopathy, a leading cause of vision loss.
• Glaucoma:Over 76 million people are affected globally today, rising to an estimated 110 million by 2040.
• Europe:64 million adults have diabetes, putting millions at risk of sight-threatening complications; nearly 8 million people are estimated to have glaucoma, many undiagnosed.

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.

“This reflects the rigor and discipline in our systems,” said Sundeep Agarwal, Senior Vice President, Quality and Regulatory Affairs, Remidio. “EU MDR is among the most stringent frameworks globally, and this achievement demonstrates that our quality and risk management meet world-class standards.”

Real-world evidence

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.

In an independent study led by a glaucoma specialist from the Netherlands, on nearly 4,000 subjects, the AI achieved a sensitivity of 88.7% and specificity of 90.8%, and ~80% sensitivity at 95% specificity. High specificity helps prevent over-referrals, while accurately identifying patients with referable glaucoma for further management.

“CE Marking materially accelerates our roll-out in Europe. With Medios, we aim to free up much-constrained ophthalmologist capacity and reduce long waiting lists, introduce preventative screening for high-risk patients at their doorsteps, and build intermediate-care capacity to provide outpatient specialist eye care outside the hospital,” said Jérôme Koelewijn, European partner OculomiX.ai.

“Glaucoma screening only works at scale if specificity is high, while sensitivity remains strong - otherwise the eye care system drowns in false positives. CE Marking enables us ophthalmologists to bring AI-guided Glaucoma screening to both secondary ánd primary care. Now we can refocus: from screening healthy eyes, to the sick eyes that demand our utmost attention,” said Dr. Hans Lemij, The Rotterdam Eye Hospital.

From Eye Care to Health Care Through the Eye

With CE Marking secured, Remidio is advancing into oculomics for the next billion. By using the eye as a window to systemic health, the company’s pipeline aims to screen for cardiovascular disease (CVD), chronic kidney disease (CKD), liver disorders, and more moving from eye care to health care through the eye.

By bridging ophthalmology and systemic health, Remidio aims to move from eye care to holistic health care through the eye, enabling early intervention and prevention for millions worldwide.