BlinkLab Ltd
BlinkLab Raises A$17.5m to Fund FDA Autism Diagnostic Clearance and Advance ADHD Trials
BlinkLab raises oversubscribed A$17.5m to push FDA autism Dx1 clearance and start ADHD Dx2 trials; Morocco rollout underpins real-world data.
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, […]