Latest Neurodevelopmental Diagnostics News

BlinkLab has secured A$17.5 million through an oversubscribed placement to fuel regulatory trials and commercial launch of its AI-driven autism and ADHD diagnostic tools.

BlinkLab has enrolled its first participant in the pivotal FDA 510(k) validation study for its autism diagnostic aid, BlinkLab Dx1, aiming for regulatory submission by the end of 2026.

BlinkLab Limited has delivered strong diagnostic results in its U.S. autism pilot study, exceeding FDA performance thresholds and setting the stage for a pivotal 510(k) trial. The company also expanded its clinical trial network and nears completion of its European ADHD study.

BlinkLab Limited has appointed its Co-Founder and CEO, Dr Henk-Jan Boele, as Managing Director to steer the company through its pivotal FDA 510(k) trial for its autism diagnostic technology. The move coincides with key board changes and signals a strategic shift as BlinkLab prepares for early commercialisation.

BlinkLab has completed its U.S. autism pilot study with strong diagnostic accuracy and expanded its pivotal FDA trial to seven leading research centers, positioning itself for regulatory submission in late 2026.

BlinkLab Limited has completed its U.S. pilot study for the Dx 1 smartphone-based autism diagnostic device, demonstrating strong accuracy and securing FDA alignment for its pivotal trial. The results mark a significant step toward transforming early neurodevelopmental diagnostics.

BlinkLab Limited reported a substantial net loss of $5.7 million for FY2025, driven by intensive R&D and clinical trial activities, while securing $7.66 million in fresh capital to fuel its smartphone-based neurodevelopmental diagnostic platform targeting autism and ADHD.

BlinkLab is advancing its FDA 510(k) clinical trials for autism and ADHD diagnostics, completing its U.S. autism pilot phase and expanding European ADHD recruitment. A recent $7.66 million capital raise supports these efforts as the company targets regulatory approvals in 2026.

BlinkLab Limited has raised A$7.66 million through a well-supported placement to accelerate FDA regulatory trials for its autism and ADHD diagnostic platforms, leveraging its innovative smartphone-based technology.

BlinkLab has launched its pivotal FDA registrational study for its AI-driven autism diagnostic app, BlinkLab Dx 1, following positive FDA feedback and promising preliminary results.