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BlinkLab’s smartphone-based diagnostic platform was designed to bring objectivity, scalability, and accessibility to the diagnosis of neurodevelopmental conditions such as autism spectrum disorder (ASD) and ADHD. Using video stimuli, smartphone cameras, and machine learning, the app analyses subtle eye movements and facial micro-expressions to identify neurological and behavioral biomarkers that traditionally require specialist observation. In its pilot study of 485 participants, BlinkLab stress-tested the Dx1 technology under demanding, real-world conditions—across varied lighting environments, smartphone types, and user settings. Despite this intentionally challenging setup, the platform achieved sensitivity and specificity levels above 80%, exceeding the 65% threshold required for regulatory clearance in the forthcoming FDA 510(k) study. These results demonstrate not only the robustness of BlinkLab’s AI model but also its readiness for real-world clinical use, setting the stage for the forthcoming pivotal 510(k) study. Comments are closed.
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