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Testimony Before the FDA’s Neurological Devices Advisory Committee Meeting Regarding BrainGate LTD’s Ischemic Stroke System

View the complete testimony as PDF

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In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Neurological Devices Advisory Committee meeting, Public Citizen urged the Committee to recommend that the FDA not approve the premarket approval application for BrainGate LTD’s Ischemic Stroke System (ISS500) because data from the pivotal phase 3 clinical trial of the device fail to provide a reasonable assurance that the device is effective.

See Public Citizen’s other work regarding specific medical devices.