BlinkLab Ltd
BlinkLab Limited is an Australia-based digital healthcare company focused on Artificial intelligence (AI) powered diagnostics.
The business
BlinkLab Limited is an Australia-based digital healthcare company focused on Artificial intelligence (AI) powered diagnostics. The Company has fully developed a smartphone based diagnostic platform for autism, Attention-Deficit/Hyperactivity Disorder (ADHD), schizophrenia, and other neurodevelopmental conditions. Its product is an autism diagnostic test that leverages the power of smartphones, AI and machine learning to deliver screening tests specifically designed for children as young as over 18 months old. Its pipeline includes BlinkLab Dx 1 and BlinkLab Dx N. Its BlinkLab Dx 1 is an autism diagnostic adjunct. Its BlinkLab Dx N is an ADHD diagnostic adjunct.
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Latest news
BlinkLab Reports Positive ADHD Assessment Results from European Dx2 Diagnostic Platform Study
BlinkLab reports ADHD Dx2 results: 82% sensitivity, 83% specificity in European study, signaling new smartphone-based diagnostic tool.
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.
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