FDA Regulatory pipeline
BlinkLab’s regulatory work is primarily focused on obtaining U.S. FDA 510(k) clearance for its diagnostic aids for autism and ADHD, with subsequent regulatory approvals in jurisdictions such as Europe (CE) and Australia (TGA) to follow.
BlinkLab’s product pipeline reflects a staged approach to clinical validation for autism and ADHD, regulatory engagement, commercialization, and post-authorization monitoring in line with FDA requirements for software as a medical device (SaMD).
Pivotal FDA 510(k) Clinical Trial Sites
BlinkLab is actively partnering with clinical sites across the U.S. to obtain FDA 510(k) clearance, with each site bringing deep expertise in neurodevelopmental diagnostics, clinical rigor, and access to diverse patient populations that will strengthen the scientific integrity of the pivotal trial.
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Drexel University
Drexel University is a private research-intensive institution located in Philadelphia, Pennsylvania, USA.
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
Pilot Study Clinical Sites
The pilot study was conducted in partnership with two leading autism centers in the U.S., helping BlinkLab refine its approach and de-risk the upcoming pivotal trial by piloting clinical protocols, study procedures, and data analysis. Key results include:
