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BlinkLab Launches Pivotal FDA Trial for Autism Diagnostic Aid
9:44am on Tuesday 24th of March, 2026 AEDT
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Healthcare
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BlinkLab Launches Pivotal FDA Trial for Autism Diagnostic Aid
9:44am on Tuesday 24th of March, 2026 AEDT
Key Points
First participant enrolled and tested in FDA 510(k) pivotal validation study
Study led by CRO IQVIA-MCRA across 10 leading US clinical sites
Pilot study showed 83.7% sensitivity and 84.7% specificity
Recruitment expected to complete in approximately 8 months
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