Remidio Secures CE Marking for Dual Offline Ophthalmic AI Developed in India

Bengaluru-based medtech innovator Remidio Innovative Solutions has achieved a major milestone with its Medios HI Glaucoma AI and Medios HI DR AI receiving CE Marking as Class II Software as a Medical Device (SaMD) under the EU Medical Device Regulation (MDR).

The certification validates Remidio’s dual offline AI, capable of detecting diabetic retinopathy and glaucoma from a single retinal image — all in under 10 seconds, without internet or cloud access.

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

According to the company, it is India’s only CDSCO-approved ophthalmic AI company, expanding its global footprint by addressing Europe’s growing burden of vision-related diseases.

Over 420 million people globally live with diabetes, with one in three at risk of diabetic retinopathy, while glaucoma affects 76 million, rising to 110 million by 2040. In Europe, 64 million have diabetes and 8 million have glaucoma. Remidio’s offline AI tool enables early, accessible detection to prevent avoidable blindness.

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

In a European study of 4,000 patients, the AI achieved 88.7% sensitivity and 90.8% specificity, demonstrating clinical reliability. Dr. Hans Lemij from The Rotterdam Eye Hospital noted, “Glaucoma screening only works at scale if specificity is high... CE Marking enables us to bring AI-guided screening to both secondary and primary care.”

Remidio now plans to advance into oculomics, using the eye as a diagnostic window for systemic diseases like CVD, CKD, and liver disorders, continuing its mission to transform eye care into holistic health care through the eye.