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 N
ADHD diagnostic adjunct
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Henk-Jan Boele, MD PhD
•
December 26, 2024

Positive outcome received from a Pre-Submission meeting with the FDA regarding the regulatory pathway for BlinkLab Dx 1 diagnostic app.

BlinkLab is thrilled to share the successful outcome of its Pre-Submission meeting with the FDA, marking a critical step toward achieving 510(k) clearance for its innovative autism diagnostic app, BlinkLab Dx 1. With the study design and data requirements now confirmed, BlinkLab is poised to initiate a robust clinical program that will pave the way for regulatory approval and market entry in the US.

Peter Boele, MA
•
December 26, 2024

Improving kids autism and ADHD diagnoses through BlinkLab collaboration with Monash University

BlinkLab partners with Monash University for a two-year MAGNET project to enhance autism and ADHD diagnosis using app-based AI technology.

Henk-Jan Boele, MD PhD
•
December 26, 2024

BlinkLab partners with Mental Care Group in Europe to improve and accelerate the diagnostic evaluation of ADHD

BlinkLab is thrilled to partner with Mental Care Group (MCG) to advance ADHD diagnosis through smartphone-based digital sensory phenotyping. By integrating BlinkLab’s innovative app into its diagnostic processes, MCG aims to enhance accuracy, efficiency, and accessibility in ADHD assessments, offering a transformative approach for patients and healthcare providers alike.

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Or see our media mentions:

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