Regulatory Pipeline
Our regulatory work is primarily focused on obtaining U.S. FDA 510(k) clearance for BlinkLab's diagnostic aids for both autism and ADHD, with subsequent regulatory approvals in jurisdictions like Europe (CE) and Australia (TGA) to follow.
BlinkLab’s product pipeline reflects a staged approach to clinical validation for autism and ADHD, regulatory engagement, and post-authorization monitoring, enabling commercialization in line with FDA requirements for software as a medical device (SaMD).
Partnering FDA Sites
Rush University Medical Center
BlinkLab announces Rush as eighth premier U.S. autism center for FDA 510(k) trial of smartphone-based diagnostic aid, with first expected subjects in Q1 2026.
Vanderbilt Kennedy Center
BlinkLab onboards the Vanderbilt Kennedy Center, a leading interdisciplinary institute at Vanderbilt University dedicated to advancing autism research.
Seattle Children's Research Institute
BlinkLab onboards Seattle Children’s Research Institute, a globally recognized leader in pediatric research and autism innovation.
Cincinnati Children's Medical Center
BlinkLab onboards Cincinatti Chilren's Medical Center, ranked among the top three pediatric hospitals in the U.S
Southwest Autism Research & Resource Center (SARRC)
BlinkLab has partnered with SARRC as a new U.S. site for its FDA autism diagnostic trial.
University of Nebraska Medical Center
BlinkLab has chosen the University of Nebraska Medical Center as its second U.S. site for its FDA autism diagnostic trial.
Perelman School of Medicine
The University of Pennsylvania has joined BlinkLab’s FDA registrational trial, bringing the world-class expertise of Dr. Heather Nuske and Prof. David Mandel to advance digital innovations in autism diagnosis and care.
Thompson Center for Autism & Neurodevelopment
The Thompson Center at the University of Missouri, a leader in autism and neurodevelopmental research, is partnering with BlinkLab to advance FDA-cleared diagnostic innovations
Latest regulatory
progress updates
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