India Pharma Outlook Team | Friday, 02 May 2025
Remidio Innovative Solutions Pvt. Ltd., a leader in ophthalmic technology, has announced that it has received approval from the State FDA, Karnataka (CDSCO), the regulatory authority for medical devices, for its Medios HI (Humanizing Intelligence) Glaucoma AI and Medios HI AMD AI. This approval represents an important advancement in the use of artificial intelligence (AI) for early detection of glaucoma and age-related macular degeneration (AMD) in diverse healthcare settings.
Following the success of the CDSCO-approved Medios DR HI, AI for diabetic retinopathy, which has impacted nearly 2,50,000 patients in the past year, the newly approved AI solutions for glaucoma and AMD are also designed to function offline. This offline capability allows real-time analysis without relying on internet access, making it useful for providing eye care in remote and underserved areas with limited access to specialized ophthalmic diagnostics.
Medios HI Glaucoma AI exceeds conventional screening methods by analyzing optic nerve head and RNFL structures, generating heat map–based reports to detect early signs of referable glaucoma. This is vital in a country like India, which accounts for 12 million glaucoma patients, nearly one in eight globally. Yet over 90% of these cases remain undiagnosed, often leading to irreversible vision loss. Early detection using portable, AI-enabled tools can drastically change this trajectory.
The Medios HI AMD AI, detects early-stage age-related macular degeneration (AMD), a major cause of vision impairment among the elderly. With 2.1% of Indians over age 60 affected, amounting to nearly 6.7 million people at risk, this tool plays a crucial role in enabling timely referrals and preventive care by highlighting lesions with AI generated heat maps.
Medios HI Glaucoma and Medios HI AMD Al has been clinically validated across tertiary hospitals, eye institute and vision centres showcasing high level of sensitivity and specificity. With Medios HI on Remidio’s FOP NM 10, a single tap delivers results for screening AMD, Glaucoma, and DR in few seconds. Three critical insights, one seamless experience.
Dr. R. Kim, Chief Medical Officer, Senior Medical Consultant, Retina & Vitreous Services Director, Aravind Eye Hospital, Madurai said “The Remidio fundus camera isn't just an imaging device; it's a portable gateway to early detection and prevention of vision-threatening conditions, bringing quality eye care closer to those who need it most”
Dr Anand Sivaraman, CEO and Founding Director, Remidio said "The CDSCO's approval of our Medios HI Glaucoma AI and Medios HI AMD AI builds upon the foundation laid by our Medios HI DR AI, which was the first ophthalmic AI software to receive such approval in India. This achievement has enabled us to screen patients, particularly in underserved regions, bringing early detection and intervention to those who need it most. The success of Medios DR AI has demonstrated the transformative potential of AI in ophthalmology, and with these new approvals, we're poised to further enhance eye care accessibility and precision across the country."
Dr Divya Rao, Chief Medical Officer, Remidio added, “These CDSCO approvals are a testament to the clinical rigor and precision that underpins our AI solutions. Both the glaucoma and AMD algorithms have been evaluated through robust prospective studies and have demonstrated strong concordance with specialist diagnosis. What excites us is their ability to bring specialist-grade diagnostics to the primary care level, empowering early intervention, particularly in settings where access to ophthalmologists is limited.”
Sundeep Agarwal, Senior Vice President - Regulatory Affairs & Quality Assurance, Remidio, stated: "Securing CDSCO approvals for our Medios HI Glaucoma AI and AMD AI reflects Remidio's deep commitment to regulatory rigor and patient safety. Navigating the complexities of AI regulation in India requires not just innovation, but robust documentation, compliance, and quality assurance at every stage. These approvals reaffirm our ability to deliver cutting-edge, regulatory-compliant solutions that meet the highest national standards, ensuring safe and scalable adoption in diverse healthcare settings."
Remidio's AI-powered solutions are integrated with its portable fundus imaging devices, facilitating seamless deployment in various clinical settings. The offline capability ensures that healthcare providers can conduct screenings without reliance on internet infrastructure, making it feasible to implement these solutions in rural and resource-limited environments.
With these approvals, Remidio continues to lead in the development of AI-driven ophthalmic diagnostics, aiming to bridge the gap in eye care delivery and contribute to the global effort in combating vision impairment.
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