BlinkLab Advances Toward FDA Approval for Autism App

Blinklab Limited (AU:BB1) has released an update.

BlinkLab Limited has made significant progress towards obtaining FDA clearance for its autism diagnostic app, BlinkLab Dx 1. The company announced a positive outcome from its Pre-Submission meeting with the FDA, which confirmed the study design and data requirements needed for approval. A large-scale clinical study involving up to 1,000 children across multiple sites in the U.S. is underway, aiming for completion within 12-16 months.

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