Butterfly Learnings Launches India’s First CDSCO-Approved Autism Screening System

The rollout will begin in Mumbai, Pune, and other Maharashtra cities, followed by Gujarat, southern Rajasthan, Raipur, Lucknow, and later Delhi and Bengaluru.

Butterfly Learnings has launched Get SET Early, a screening system for autism in young children, which it says is the first-of-its-kind in India to receive approval from the Central Drugs Standard Control Organisation (CDSCO).

The system combines eye-tracking with behavioral science to detect risk of autism spectrum disorder (ASD) as early as 12 to 24 months of age.

The product is built on research by Dr. Karen Pierce, Co-Director of the University of California San Diego (UCSD) Autism Center of Excellence. Butterfly Learnings holds exclusive rights to use this technology in India.

The tool is designed for children between one and four years old and produces an objective autism risk score within minutes.

According to the startup, the rollout will begin in Mumbai, Pune, and other Maharashtra cities, followed by Gujarat, southern Rajasthan, Raipur, Lucknow, and later Delhi and Bengaluru. The startup places devices with pediatricians at minimal or no upfront cost, with clinics paying per completed screening.

Screening is expected to cost less than ₹1,500 per child, though the final price will be set by clinicians. The startup is also offering the system in preschools through screening camps and integrating it into regular well-baby check-ups and vaccination schedules.

Startup Details

Butterfly Learnings, founded in 2021, operates clinics and digital platforms focused on pediatric neurodevelopmental care. Its services span diagnosis, therapy, and ongoing support for children with conditions such as autism, ADHD, and learning disabilities.

The launch of Get SET Early is positioned as part of its broader strategy to expand early identification and intervention capabilities in India.

Reportedly, Butterfly Learnings had revenue of ₹16 Cr in FY25, with more than ₹2 Cr earned per month currently. The startup projects that Get SET Early will account for about 30 percent of revenues in three to five years.

To date, Butterfly Learnings has raised ₹47 Cr from investors including Insitor Fund, Enzia, and IIMA Ventures, and it is targeting operational break-even in the current fiscal year. The startup frames the market opportunity around India’s high birth rate, about 2.5 Cr births annually, and its estimate that around 3.5 Cr children in the country have neurodevelopmental delays.

The UCSD research that underpins the product is based on eye-tracking biomarkers, including the “GeoPref” test. Peer-reviewed studies from the UCSD Autism Center of Excellence have shown that toddlers with a strong preference for geometric patterns over social scenes are more likely to be diagnosed with autism, often with more severe symptoms.

Published results indicate the test can identify a subset of toddlers at risk for autism before age two, with low false-positive rates.

The startup has not disclosed detailed data on India-specific validation studies, and most of the published research has been conducted in the United States. Details of the CDSCO approval, such as device classification, have not been made public.

Insurance coverage for the screening is limited, which could make cost a barrier for families until wider reimbursement or government adoption occurs. Data protection policies for children’s video and eye-tracking data have also not been specified.

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