BLINKLAB ORD
BlinkLab Commences Pivotal FDA 510(k) Validation Program with First Participant Enrolment
BlinkLab kicks off pivotal FDA 510(k) validation for Dx1 autism diagnostic aid; first participant enrolled as an 8-month study targeting end-2026 submission.
BlinkLab Completes Pivotal FDA Study Site Network Ahead of Q1 2026 Trial Start
BlinkLab completes 10-site pivotal FDA study network ahead of March 2026 start; pilot 83.7%/84.7%; 510(k) submission H2 CY2026.
BlinkLab Dx 1 Device Pilot Study Confirms High Diagnostic Accuracy and Readiness for FDA Trial
BlinkLab (ASX: BB1) has completed a US pilot study evaluating the smartphone-based Dx 1 diagnostic device for the assessment of behavioural and developmental concerns in children, including autism spectrum disorder and attention deficit hyperactivity disorder. The unblinded study involved 485 clinically-diverse children aged between 2 years and 11 years, representing the full spectrum of developmental concerns, […]
BlinkLab partners with INTER-PSY to improve wait times for autism diagnosis in children
Digital healthcare company BlinkLab (ASX: BB1) has formed a research and clinical partnership with Netherlands-based INTER-PSY to improve wait times for autism diagnosis in children. INTER-PSY offers mental health care, guidance and diagnosis to children and adults with psychological and psychiatric conditions. The partnership will support the adoption of BlinkLab as a diagnostic tool within […]