BlinkLab Expands Pivotal FDA Trial Network to Nine Elite U.S. Sites

Drexel University joins leading children's hospitals and autism research centers ahead of Q1 2026 study launch

Published on Feb. 12, 2026

Got story updates? Submit your updates here. ›

BlinkLab Limited, a leader in AI-powered digital diagnostics, has expanded its U.S. clinical footprint with the onboarding of Drexel University as the ninth site in its pivotal FDA 510(k) trial for BlinkLab Dx 1, the company's Software as a Medical Device (SaMD) autism diagnostic aid. The addition of Drexel University strengthens what is emerging as one of the most comprehensive and clinically rigorous digital autism diagnostic studies conducted to date, ahead of anticipated study commencement in Q1 2026.

Why it matters

The pivotal 510(k) trial is designed not only to support regulatory clearance, but also to anchor BlinkLab within a network of leading U.S. autism research and clinical institutions. Collectively, the nine sites represent a geographically diverse and demographically representative sample of the U.S. population, each with a proven track record in autism research and clinical trial execution. Beyond regulatory evidence generation, these collaborations are expected to play a critical role in informing real-world clinical workflows, supporting guideline and payer engagement, and accelerating adoption upon FDA clearance.

The details

The FDA-endorsed pivotal study will enroll approximately 528 children aged 2–11 years across the network of leading U.S. institutions. Drexel joins an established group that includes Cincinnati Children's Hospital, Seattle Children's Hospital, the University of Pennsylvania, MU Thompson Center for Autism & Neurodevelopmental Disorders, Southwest Autism Research & Resource Center, University of Nebraska Medical Center, Vanderbilt Kennedy Center, and Rush University Medical Center. The successful completion of BlinkLab's U.S. Pilot Study involving 485 children, announced in October 2025, demonstrated 83.7% sensitivity and 84.7% specificity, significantly exceeding the performance thresholds agreed with the FDA for progression into the pivotal 510(k) study.

  • The pivotal 510(k) trial is expected to commence in Q1 2026.
  • BlinkLab's U.S. Pilot Study was completed in October 2025.

The players

BlinkLab Limited

A leader in AI-powered digital diagnostics and the developer of BlinkLab Dx 1, a Software as a Medical Device (SaMD) autism diagnostic aid.

Drexel University

A private, research-intensive institution based in Philadelphia, Pennsylvania, with the A.J. Drexel Autism Institute playing a nationally recognized role in population-level autism surveillance, diagnostic access, and evidence-based policy development.

Dr. Henk-Jan Boele

Co-founder and CEO of BlinkLab.

Got photos? Submit your photos here. ›

What they’re saying

“I am very pleased to see an institution with such a longstanding track record of leadership in autism and neurodevelopmental research join BlinkLab for its FDA 510(k) diagnostic program. The University has enormous expertise across its research programs and specific autism initiatives will make it a valuable partner for this pivotal stage of our own clinical work.”

— Dr. Henk-Jan Boele, Co-founder and CEO of BlinkLab (einpresswire.com)

What’s next

The pivotal 510(k) trial is expected to commence in Q1 2026 following the successful completion of BlinkLab's U.S. Pilot Study.

The takeaway

The expansion of BlinkLab's pivotal FDA trial network to nine elite U.S. sites, including the addition of Drexel University, strengthens the clinical rigor and credibility of the study, positioning BlinkLab Dx 1 to potentially become a first-of-its-kind, AI-powered diagnostic aid capable of addressing long waitlists, regional inequities, and delayed access to autism care and support across the U.S. healthcare system.