Read our recent announcements about our company, our research, and partnerships.
BlinkLab announced the commencement of its validation program supporting 510(k) submission, with the first child participant now enrolled and having completed initial testing using BlinkLab Dx1.
BlinkLab announces its involvement in a landmark national autism screening and capacity-building initiative launched by the Kingdom of Morocco.
BlinkLab announces the onboarding of University of Arkansas as the tenth and final clinical site for the Company’s upcoming pivotal U.S. regulatory trial for BlinkLab Dx 1.
Formation of new partnership with the SHANK2 Foundation, a U.S.-based not-for-profit organisation with a focus on advocacy, awareness, the creation of research infrastructure.
BlinkLab announced that Drexel University has joined as a clinical site for the Company’s pivotal U.S. regulatory trial for BlinkLab Dx 1.
BlinkLab receives R&D Tax Incentive Refund relating to its U.S. Pilot Study and Australian clinical research initatives
BlinkLab Dx 1 achieved 83.7% sensitivity and 84.7% specificity in a clinically diverse pediatric population, confirming robust real-world diagnostic performance.
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.
BlinkLab showcases smartphone-mediated neurobehavioral testing as a digital biomarker at Neuroscience 2022.
Let's make developmental diagnostic evaluation more efficient and accessible.
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