FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

MaxQ AI’s Intracranial Hemorrhage Platform Cleared by FDA

Nov. 8, 2018
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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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