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Universal Brain secures FDA clearance for EEG-based psychiatric assessment tool

Universal Brain has received FDA 510(k) clearance for its Neurotique™ platform, a device designed to assess cognitive and emotional brain function for psychiatric diagnosis and treatment. The platform utilizes a dry EEG baseball cap with EOG electrodes and an integrated digital testing system to measure brain activity via event-related potentials. Founded in 2022, Universal Brain has secured $7.9 million in seed funding and a $2 million grant from the Japanese government, with plans to launch clinically this summer and pursue pharma contracts. AI

IMPACT This FDA clearance for a neurotech device could accelerate the integration of AI-driven diagnostics in mental healthcare, potentially improving treatment accuracy and patient outcomes.

RANK_REASON FDA clearance for a neurotech device for psychiatric assessment.

Read on Forbes — Innovation →

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Universal Brain secures FDA clearance for EEG-based psychiatric assessment tool

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FDA clearance for a neurotech device for psychiatric assessment.
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COVERAGE [1]

  1. Forbes — Innovation TIER_1 English(EN) · Naveen Rao, Contributor ·

    Psychiatry Lacks Biomarkers. Can This EEG Ballcap Get A Base Hit?

    Universal Brain's EEG cap seeks to bring precision into mental health treatment and drug development. With $7.9 million raised, they are entering a fast-moving landscape.