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Regulatory Progress Announcements

Read our recent announcements about our company, our research, and partnerships.

Latest announcement

BlinkLab Granted Foundational U.S. Patent Covering Remote Neurobehavioural Testing Platform

U.S. Patent Granted for Remote Neurobehavioural Testing Platform

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June 18, 2026
Regulatory Progress
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BlinkLab Granted Foundational U.S. Patent Covering Remote Neurobehavioural Testing Platform

U.S. Patent Granted for Remote Neurobehavioural Testing Platform

Jun 18, 2026

Commencement of Pivotal Validation Program for FDA 510(k) Submission: First Participant Enrolled

BlinkLab announced the commencement of its validation program supporting 510(k) submission, with the first child participant now enrolled and having completed initial testing using BlinkLab Dx1.

Mar 24, 2026

Completion of Clinical Trial Network for Pivotal FDA Study with Addition of Tenth Clinical Site – University of Arkansas

BlinkLab announces the onboarding of University of Arkansas as the tenth and final clinical site for the Company’s upcoming pivotal U.S. regulatory trial for BlinkLab Dx 1.

Mar 16, 2026

Expansion of Pivotal FDA Trial Network to Nine Elite U.S. Sites Ahead of Imminent Study Commencement – Drexel Univerisity

BlinkLab announced that Drexel University has joined as a clinical site for the Company’s pivotal U.S. regulatory trial for BlinkLab Dx 1.

Feb 12, 2026

High-Profile Journal Publication Validates BlinkLab's Technology

High-profile publication in leading journal "Autism Research" validates BlinkLab’s technology, providing support for future clinical adoption

Jan 5, 2026

Rush University Medical Center Joins BlinkLab’s Pivotal U.S. Autism Diagnostic Trial

BlinkLab announces Rush as eighth premier U.S. autism center for F1DA 510(k) trial of smartphone-based diagnostic aid, with first expected subjects in Q1 2026.

Nov 13, 2025

Pilot Study Confirms High Diagnostic Accuracy and Readiness for FDA Trial

BlinkLab Dx 1 achieved 83.7% sensitivity and 84.7% specificity in a clinically diverse pediatric population, confirming robust real-world diagnostic performance.

Oct 22, 2025

BlinkLab Adds University of Missouri’s Thompson Center as Sixth Clinical Site for FDA Trial

Marking another step toward FDA clearance for its autism diagnostic tool.

Sep 17, 2025

Two additional strategic partnerships with top ranked U.S. institutions advance BlinkLab’s FDA submission

Partnerships with Leading Pediatric Institutions Strengthen BlinkLab’s U.S. Trial Network

Sep 16, 2025