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BlinkLab Finalises Clinical Network Ahead of Pivotal FDA Autism Trial
9:54am on Monday 16th of March, 2026 AEDT
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Healthcare
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BlinkLab Finalises Clinical Network Ahead of Pivotal FDA Autism Trial
9:54am on Monday 16th of March, 2026 AEDT
Key Points
University of Arkansas joins as tenth and final clinical site
Pivotal FDA 510(k) trial to enrol at least 528 children across US sites
Pilot study showed 83.7% sensitivity and 84.7% specificity, exceeding FDA benchmarks
Trial to validate usability and diagnostic accuracy of BlinkLab Dx 1
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