Bengaluru-based medtech innovator Forus Health has obtained CDSCO clearance for its AI-driven diabetic retinopathy screening solution, FH-POISE DRT, classified as a high-risk Class C Software as a Medical Device. The tool uses deep learning to analyze retinal images for early risk detection, addressing India’s massive diabetes burden and enabling scalable, preventive eye care in routine clinical settings
Glimpse:
Forus Health’s FH-POISE DRT has received regulatory nod from India’s Central Drugs Standard Control Organization (CDSCO) as a Class C SaMD, validated on diverse real-world retinal datasets. The AI platform analyzes fundus images to predict diabetic retinopathy severity, identify at-risk patients, and support timely interventions to prevent vision loss. With India home to nearly 90 million adults with diabetes in 2024, the tool aims to integrate into hospitals, public health programs, and diabetes clinics optimizing specialist resources and tackling the scale challenge in early detection amid significant economic losses from diabetes-related blindness.
Forus Health, a leading Bengaluru-based medical technology company specializing in AI-powered ophthalmic solutions, has announced regulatory approval from the Central Drugs Standard Control Organization (CDSCO) for its FH-POISE DRT Precision Ocular Intelligence for Systemic & Eye Health Diabetic Retinopathy Tools. This clearance, granted for a Class C Software as a Medical Device (one of the highest risk categories under Indian regulations), paves the way for widespread deployment of the AI tool to screen for diabetic retinopathy, a leading cause of preventable blindness in people with diabetes.
The FH-POISE platform employs advanced deep learning algorithms to process retinal fundus images, accurately predicting disease severity and flagging patients who require earlier clinical evaluation. Unlike traditional methods that rely heavily on specialist ophthalmologists, this solution enables nuanced, clinically relevant outcomes even in non-specialist settings. Validation involved real-world retinal images from diverse Indian demographics, confirming its robustness and suitability for everyday healthcare environments.
India faces a staggering diabetes epidemic, with approximately 89.8 million adults affected in 2024 according to the International Diabetes Federation. Diabetic retinopathy contributes to substantial vision impairment and blindness, resulting in productivity losses exceeding Rs 11,000 crore annually as per peer-reviewed studies. The challenge extends beyond awareness to scalability—embedding reliable screening into routine diabetes care is critical to prevent avoidable vision loss and ease pressure on limited eye specialists.
With CDSCO approval secured, FH-POISE DRT is now poised for integration across hospitals, public health screening initiatives, and diabetes management programs nationwide. It supports India’s preventive healthcare goals by bringing AI-enabled early detection closer to where patients already seek care, ultimately improving outcomes and resource efficiency in the fight against diabetes-related complications.
This milestone reinforces Forus Health’s commitment to innovative eye care technologies, building on its portfolio of AI solutions for conditions like glaucoma, retinopathy of prematurity, and more.
“India’s challenge with diabetic retinopathy is not awareness alone, but scale. Embedding reliable screening into routine diabetes care is essential if we are to prevent avoidable vision loss. Regulatory approval for FH-POISE™ DRT enables technology-focused screening closer to where patients already receive care, helping strengthen early detection while making better use of limited specialist capacity.”
By
HB Team
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