BlinkLab Expands FDA Autism Trial to Five US Sites, Targeting 900 Participants
BlinkLab Limited has expanded its pivotal FDA autism diagnostic trial by partnering with two leading US pediatric institutions, enhancing recruitment and clinical credibility ahead of its 2026 submission.
- Cincinnati Children’s Medical Center and Seattle Children’s Research Institute join BlinkLab’s FDA trial network
- Total US clinical sites for autism diagnostic trial now five, improving patient diversity and recruitment
- Trial aims to enroll up to 900 participants with completion expected by Q2 2026
- FDA 510(k) submission for BlinkLab Dx 1 targeted for Q3 2026
- Partnerships strengthen clinical validation and market positioning in autism diagnostics
Strategic Expansion of Clinical Trial Network
BlinkLab Limited (ASX – BB1), a digital healthcare innovator developing AI-powered diagnostic tools, has announced two significant additions to its clinical trial network for its FDA 510(k) autism diagnostic study. Cincinnati Children’s Medical Center and Seattle Children’s Research Institute, both highly ranked pediatric institutions in the United States, have joined the pivotal trial for BlinkLab’s smartphone-based diagnostic platform, BlinkLab Dx 1.
This expansion brings the total number of US clinical sites involved in the study to five, a move designed to accelerate participant recruitment and enhance the geographic and demographic diversity of the trial population. The inclusion of these world-renowned centers not only bolsters the scientific rigor of the study but also lends considerable credibility to BlinkLab’s technology as it moves toward regulatory approval.
Clinical and Market Significance
Autism diagnosis traditionally relies on lengthy clinical observation, often delaying intervention during critical early developmental stages. BlinkLab’s AI-driven platform aims to transform this landscape by providing an accessible, objective, and scalable diagnostic tool capable of screening children as young as 18 months. The FDA 510(k) trial is designed as a double-blind study enrolling at least 520 children, split evenly between those diagnosed with autism and neurotypical controls, with potential enrollment reaching up to 900 participants.
Completion of the trial is expected by the second quarter of 2026, with the company targeting a regulatory submission to the FDA in the third quarter. The involvement of Cincinnati Children’s and Seattle Children’s, both leaders in pediatric autism research and care, is expected to enhance data quality and support a robust submission package.
Leadership Perspective and Future Outlook
Dr. Henk-Jan Boele, BlinkLab’s Co-founder and CEO, highlighted the importance of these partnerships, noting that the institutions’ reputations and clinical trial expertise will be instrumental in driving recruitment and validating the technology. This milestone positions BlinkLab strongly within the fast-growing autism diagnostics market, where demand for early and efficient screening tools is rising sharply.
Looking ahead, BlinkLab’s ability to leverage these partnerships for further clinical validation and eventual market adoption will be critical. The company’s blend of cutting-edge AI technology and collaboration with top-tier pediatric research centers underscores its potential to reshape autism diagnosis and intervention.
Bottom Line?
BlinkLab’s strategic partnerships mark a pivotal step toward FDA approval and broader adoption of its AI-driven autism diagnostic platform.
Questions in the middle?
- How quickly will BlinkLab achieve its recruitment targets across the expanded clinical sites?
- What competitive responses might emerge in the digital autism diagnostics space as BlinkLab advances?
- How will BlinkLab’s FDA submission be received given the evolving regulatory landscape for AI-based medical devices?
