FDA Approves First Medical Device for Autism Diagnosis in Children

May 9, 2025

In a groundbreaking development for autism diagnosis, the U.S. Food and Drug Administration has approved the first medical device. This device is specifically designed to aid in the diagnosis of autism spectrum disorder (ASD) in children.

What is the EarliPoint Evaluation?

The FDA-approved device is called the “EarliPoint Evaluation.” It uses eye-tracking technology. This technology measures a child’s visual engagement with social versus non-social content on a screen. The system analyzes how children aged 16 to 30 months look at videos showing people interacting compared to geometric patterns.

Research has shown that children with autism typically show less interest in social stimuli compared to typically developing children. This difference in visual attention patterns forms the basis of the diagnostic approach used by this new technology.

How does it work?

During the evaluation:

• Children sit on a caregiver’s lap and watch a series of brief videos
• The device tracks and analyzes their eye movements
• Results are compared against an established database
• The system generates an assessment of social visual engagement

The entire process takes just minutes to complete. This speed potentially allows for earlier diagnosis. Traditional methods often involve lengthy waitlists and multiple specialist appointments.

Why this matters

This FDA approval represents a significant milestone in autism diagnostics for several important reasons:

1. Earlier intervention opportunities: Earlier diagnosis typically leads to earlier intervention. Research consistently shows that earlier intervention yields better outcomes for children with autism.
2. Addressing the diagnostic bottleneck: Many families face long wait times. These can be 12 months or longer to receive an autism diagnosis through traditional routes. This technology could help streamline the diagnostic process.
3. Objectivity in assessment: The eye-tracking system provides objective measurements rather than relying solely on subjective clinical observations.
4. Accessibility: The technology may eventually help expand diagnostic capabilities to underserved communities where specialist access is limited.

Dr. Thomas Frazier, chief science officer at Autism Speaks, noted an important point. This technology won’t replace comprehensive clinical evaluation. However, it represents an important step forward. It makes autism diagnosis more efficient and accessible.

Important considerations

While this approval marks a significant advancement, experts emphasize several key points:

• The EarliPoint Evaluation is designed to be used by healthcare providers alongside traditional diagnostic methods, not as a standalone test
• It’s intended to supplement, not replace, clinical judgment
• The technology has demonstrated good accuracy but isn’t perfect
• Follow-up with developmental specialists remains essential

What’s next?

The developer of the EarliPoint Evaluation is EarliTec Diagnostics. The company plans to begin rolling out the technology to select clinical sites later this year. The company is also conducting ongoing research to refine the system and potentially expand its applications.

For families concerned about developmental delays, this technology represents hope for earlier diagnosis. It allows intervention that can potentially make a meaningful difference in outcomes for thousands of children on the autism spectrum.

Explore our other articles at 101autism.com for more information about autism diagnosis, early intervention, and support resources.