Forus Health Receives CDSCO Approval for AI-Powered Diabetic Retinopathy Screening Tool in India
Key Insights
Forus Health (search) has secured regulatory approval from India's CDSCO (search) for its FH-POISE DRT (search), an AI-powered diabetic retinopathy (search) screening tool designed to identify at-risk patients and prevent vision loss.
The software received Class C SaMD approval, the most stringent risk category, and uses deep learning models to assess retinal images and predict disease severity across diverse healthcare settings.
With approximately 89.8 million adults living with diabetes (search) in India and 12-17% developing diabetic retinopathy (search), the tool addresses a critical gap in screening access outside major urban centers.
Forus Health (search), a global medical technology company focused on transforming eye care through innovative devices and AI-powered solutions, has received regulatory approval from India's Central Drugs Standard Control Organization (search) (CDSCO (search)) for its FH-POISE DRT (search) (Diabetic Retinopathy (search) Tools). The approval marks a significant milestone in addressing India's substantial diabetes (search)-related vision care challenges through artificial intelligence technology.
AI-Powered Screening Technology
FH-POISE (Precision Ocular Intelligence for Systemic & Eye Health) represents Forus Health (search)'s AI-powered retinal image analysis platform designed to support the detection and screening of ocular and systemic diseases using state-of-the-art algorithms. The software employs deep learning models to assess retinal images and predict disease severity, enabling more nuanced and clinically relevant screening outcomes.
The technology has received CDSCO (search) approval as Class C SaMD (Software as a Medical Device), representing one of the most stringent risk categories. The validation approach utilized real-world retinal images spanning diverse demographics, demonstrating the tool's suitability for real-world healthcare settings across India's varied population.
Addressing India's Diabetes Burden
India faces one of the world's largest diabetes (search) burdens, with approximately 89.8 million adults living with diabetes in 2024, according to the International Diabetes Federation (search). This massive patient population places sustained pressure on the healthcare system, particularly in the area of diabetic complications screening.
Multiple population-based studies and meta-analyses indicate that around 12%-17% of people with diabetes (search) in India have diabetic retinopathy (search), with prevalence varying by geography and access to care. Despite this significant disease burden, published research highlights that a majority of people with diabetes do not undergo regular retinal screening, particularly outside major urban centers where specialist availability is limited.
Clinical and Economic Impact
The approval enables FH-POISE DRT (search) to function as a screening tool to identify patients at risk of diabetic retinopathy (search), supporting earlier clinical evaluation and timely intervention to help prevent diabetes (search)-related vision loss. This capability addresses a critical gap in India's healthcare delivery system.
"India's challenge with diabetic retinopathy (search) is not awareness alone, but scale," said Chandrasekhar K., Founder and CEO of Forus Health (search). "Embedding reliable screening into routine diabetes (search) care is essential if we are to prevent avoidable vision loss. Regulatory approval for FH-POISE DRT (search) enables technology-focused screening closer to where patients already receive care, helping strengthen early detection while making better use of limited specialist capacity."
The economic implications of delayed diagnosis are substantial. Peer-reviewed studies estimate that vision impairment (search) and blindness (search) in India result in productivity losses exceeding ₹11,000 crore annually, highlighting the societal cost of inadequate screening and treatment infrastructure.
Regulatory Validation and Deployment Plans
From a regulatory perspective, the CDSCO (search) approval reflects rigorous validation processes and alignment with India's clinical and safety requirements. "This CDSCO approval reflects rigorous validation, quality systems, and alignment with India's clinical and safety requirements," stated RJ Venkataraman, Chief Manufacturing and Regulatory Officer at Forus Health (search). "This clearance allows us to responsibly scale deployment across diverse healthcare settings while maintaining consistency, reliability, and patient safety."
The FH-POISE DRT (search) system is designed for deployment at the point of care, supporting AI-assisted retinal screening across general hospitals, diabetes (search) clinics, community health centers, and outreach programs. By enabling earlier identification of patients requiring further evaluation, the technology supports more efficient use of ophthalmology resources and strengthens preventive eye-care delivery.
With CDSCO (search) approval secured, Forus Health (search) plans to deploy FH-POISE DRT (search) across hospitals, public health initiatives, and screening programs, aligning with India's focus on preventive healthcare and digital health-enabled early diagnosis. This deployment strategy aims to bridge the gap between diabetes (search) care and specialized ophthalmology services, particularly in underserved regions where access to eye care specialists remains limited.