Forus Health secures CDSCO approval for AI-led Diabetic Retinopathy screening tool in India

New Delhi: Forus Health, a leading global medical technology company dedicated to transforming eye care through innovative devices and AI-powered solutions, has received regulatory approval from the Central Drugs Standard Control Organization (CDSCO) for its FH-POISE™ DRT (Diabetic Retinopathy Tools).

FH-POISE™ (Precision Ocular Intelligence for Systemic & Eye Health) is Forus Health’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 approval enables FH-POISE™ DRT to be used as a screening tool to identify patients at risk of diabetic retinopathy, supporting earlier clinical evaluation and timely intervention to help prevent diabetes-related vision loss. The software uses deep learning models to assess retinal images and predict disease severity, allowing for more nuanced and clinically relevant screening outcomes. It has received CDSCO approval as Class C SaMD (Software as a Medical Device), one of the most stringent risk categories, with the approach validated on real-world retinal images, spanning a diverse demography, demonstrating suitability for real-world healthcare settings.

India carries one of the world’s largest diabetes burdens. According to the International Diabetes Federation, approximately 89.8 million adults in India were living with diabetes in 2024, placing sustained pressure on the healthcare system. Multiple population-based studies and meta-analyses indicate that around 12%–17% of people with diabetes in India have diabetic retinopathy, with prevalence varying by geography and access to care. At the same time, published research highlights that a majority of people with diabetes do not undergo regular retinal screening, particularly outside major urban centres where specialist availability is limited.

“India’s challenge with diabetic retinopathy is not awareness alone, but scale,” said Chandrasekhar K., Founder and CEO, Forus Health, “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-focussed screening closer to where patients already receive care, helping strengthen early detection while making better use of limited specialist capacity.”

“From a regulatory standpoint, this CDSCO approval reflects rigorous validation, quality systems, and alignment with India’s clinical and safety requirements,” said RJ Venkataraman, Chief Manufacturing and Regulatory Officer, Forus Health, “This clearance allows us to responsibly scale deployment across diverse healthcare settings while maintaining consistency, reliability, and patient safety.”

The broader economic impact of vision impairment further underscores the importance of early detection. Peer-reviewed studies estimate that vision impairment and blindness in India result in productivity losses exceeding ₹11,000 crore annually, highlighting the societal cost of delayed diagnosis and treatment.

Designed for deployment at the point of care, FH-POISE™ DRT supports AI-assisted retinal screening across general hospitals, diabetes clinics, community health centres, and outreach programmes. By enabling earlier identification of patients requiring further evaluation, it supports more efficient use of ophthalmology resources and strengthens preventive eye-care delivery. With CDSCO approval in place, Forus Health plans to deploy FH-POISE™ DRT across hospitals, public health initiatives, and screening programs, aligned with India’s focus on preventive healthcare and digital health–enabled early diagnosis.