Latest Autism Diagnostics News

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.

BlinkLab has secured US Institutional Review Board approval to proceed with the main phase of its FDA 510(k) trial for an AI-powered autism diagnostic tool, marking a key step toward regulatory clearance.

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 secured North Shore Pediatric Therapy as the second US clinical site in its autism diagnostic study, enhancing recruitment and data quality with a leading Chicago-based specialist.

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.