Latest Autism Diagnostics News

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’s smartphone-based Dx1 autism screening technology has been selected for Morocco’s government-funded national early screening program, marking a major milestone in digital health adoption and autism care.

BlinkLab has completed onboarding its tenth and final clinical site for its pivotal FDA 510(k) trial of an AI-powered autism diagnostic aid, setting the stage for patient enrolment to begin this month.

BlinkLab has expanded its pivotal FDA 510(k) autism diagnostic trial to nine top U.S. sites, adding Drexel University ahead of the Q1 2026 study start. This move follows a successful pilot study that exceeded FDA benchmarks, positioning BlinkLab Dx 1 for regulatory clearance.

BlinkLab Limited has secured independent scientific validation for its smartphone-based autism diagnostic technology through publication in the prestigious journal Autism Research, marking a significant milestone ahead of its FDA regulatory trial.

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 Limited has expanded its pivotal FDA autism diagnostic trial by partnering with two leading US pediatric institutions, enhancing recruitment and clinical credibility ahead of its 2026 submission.

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 has expanded its pivotal FDA autism diagnostic trial by adding the University of Nebraska Medical Center as a second U.S. clinical site, advancing toward broader validation and regulatory clearance.