Henk-Jan Boele, MD PhD
•
Dec 19, 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.
