BlinkLab Finalises U.S. Clinical Network for Pivotal FDA Autism Diagnostic Trial

Blinklab Limited ( (AU:BB1) ) just unveiled an announcement.

BlinkLab Limited has completed onboarding of its tenth and final clinical site, the University of Arkansas, for its pivotal FDA 510(k) trial of BlinkLab Dx 1, a smartphone-based diagnostic aid for autism. The expanded network of ten leading U.S. autism centres is designed to provide a geographically and demographically diverse patient cohort, supporting what the company describes as one of the most rigorous digital health autism diagnostic studies to date.

The pivotal study, set to begin in the first quarter of 2026 with first patient testing expected by the end of March, will enrol at least 528 children aged two to eleven to validate both the usability and diagnostic accuracy of BlinkLab Dx 1. The trial design is underpinned by a prior U.S. pilot study in 485 children in which the technology exceeded FDA-agreed performance benchmarks, potentially de-risking the pivotal program and strengthening BlinkLab’s position as it advances toward U.S. regulatory clearance and future commercialisation.

More about Blinklab Limited

BlinkLab Limited is an ASX-listed developer of AI-powered digital diagnostics focused on smartphone-based tools to aid in the detection of neurodevelopmental conditions such as autism. Its flagship product, BlinkLab Dx 1, targets clinical adoption in leading autism centres and academic institutions, with a primary market focus on the U.S. regulatory and healthcare landscape.

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