Forus Health has received regulatory approval from the Central Drugs Standard Control Organization (CDSCO) for its AI-based diabetic retinopathy screening solution, FH-POISE DRT (Diabetic Retinopathy Tools), marking a significant milestone in the use of regulated artificial intelligence for preventive eye care in India.
FH-POISE, short for Precision Ocular Intelligence for Systemic & Eye Health, is an AI-powered retinal image analysis platform developed by Forus Health to support the detection and screening of ocular and systemic diseases using advanced algorithms. With CDSCO clearance, FH-POISE DRT can now be deployed as a screening tool to identify individuals at risk of diabetic retinopathy, enabling earlier clinical evaluation and timely intervention to help prevent diabetes-related vision loss.
The software uses deep learning models to analyse retinal images and predict disease severity, supporting more clinically relevant screening outcomes. It has been approved as a Class C Software as a Medical Device (SaMD), one of the highest risk categories under India’s medical device regulatory framework. The system has been validated using real-world retinal images across a diverse demographic population, demonstrating its suitability for deployment in real-world healthcare settings.
India bears one of the world’s largest diabetes burdens. Data from the International Diabetes Federation indicate that around 89.8 million adults in the country were living with diabetes in 2024, placing sustained pressure on the healthcare system. Population-based studies and meta-analyses suggest that 12% to 17% of people with diabetes in India develop diabetic retinopathy, with prevalence varying based on geography and access to care. Despite this, published research shows that a large proportion of people with diabetes do not undergo regular retinal screening, particularly outside major urban centres where specialist availability is limited.
Beyond clinical impact, the economic burden of vision impairment further highlights the importance of early detection. Peer-reviewed studies estimate that vision impairment and blindness in India lead to annual productivity losses exceeding ₹11,000 crore, underscoring the societal cost of delayed diagnosis and treatment.
Designed for point-of-care deployment, FH-POISE DRT supports AI-assisted retinal screening across general hospitals, diabetes clinics, community health centres and outreach programmes. By enabling early identification of patients who require further ophthalmic evaluation, the platform aims to improve utilisation of limited specialist resources and strengthen preventive eye-care delivery.
Following CDSCO approval, Forus Health plans to deploy FH-POISE DRT across hospitals, public health initiatives and screening programmes, in alignment with India’s broader push towards preventive healthcare and digital health-enabled early diagnosis.
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