FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

MaxQ AI’s Intracranial Hemorrhage Platform Cleared by FDA

Nov. 8, 2018

The FDA granted 510(k) clearance to MaxQ AI’s Accipio Ix intracranial hemorrhage platform.

The device is designed to detect intracranial hemorrhage (ICH), commonly known as brain bleed, in adult non-contrast head computed tomography.

Accipio Ix, which received the CE Mark earlier in the year, uses AI algorithms to identify and mark potential regions of interest related to acute ICH.

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