Regulatory Pipeline

Our R&D pipeline is focused on obtaining FDA 510(k) clearance and EU regulatory  approval for BlinkLab as a diagnostic adjunct for autism and ADHD.

Product
Name
Product
Description
Clinical Feasibility
Studies
Pivotal Clinical
Studies
Regulatory
Approval
Post
Authorization
BlinkLab Dx 1
Autism diagnostic adjunct
BlinkLab Dx 2
ADHD diagnostic adjunct
Scroll to see more

Partnering FDA Sites

Vanderbilt Kennedy Center

ChatGPT said: BlinkLab onboards the Vanderbilt Kennedy Center, a leading interdisciplinary institute at Vanderbilt University dedicated to advancing autism research.

Read more

Seattle Children's Research Institute

BlinkLab onboards Seattle Children’s Research Institute, a globally recognized leader in pediatric research and autism innovation.

Read more

Cincinnati Children's Medical Center

BlinkLab onboards Cincinatti Chilren's Medical Center, ranked among the top three pediatric hospitals in the U.S

Read more

Southwest Autism Research & Resource Center (SARRC)

BlinkLab has partnered with SARRC as a new U.S. site for its FDA autism diagnostic trial.

Read more

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.

Read more

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.

Read more

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

Read more

PriMed

BlinkLab Initiates its First US-based Clinical Site for Autism Diagnostic Registrational Trial

Read more

Northshore

North Shore Pediatric Therapy in Chicago Joins BlinkLab’s US Registrational Study

Read more

INTER-PSY

BlinkLab signs partnership for clinical trial with European INTER-PSY, supporting US and EU regulatory approval and future market adoption

Read more

Turning Pointe Autism Foundation

BlinkLab commences partnership with Turning Pointe Autism Foundation for clinical study in children with autism in the US

Read more

Latest regulatory
progress updates

Awesome! You're now signed up.

You will receive our newsletter. You can opt out via the newsletter.

Oops! Something went wrong while submitting the form.