Zebra's AI algorithm for CT brain bleeds gets FDA OK

Artificial intelligence (AI) software developer Zebra Medical Vision has received U.S. Food and Drug Administration (FDA) 510(k) clearance for an AI algorithm that can detect and classify intracranial hemorrhage on head CT scans.

Zebra's HealthICH AI algorithm consists of a neural network architecture designed to distinguish intracranial hemorrhage from small brain bleeds and image artifacts on brain CT scans. The algorithm can use this information to prioritize acute cases requiring emergency care and then alert clinicians of positive cases by sending them to the top of the worklist.

The AI algorithm's ability to detect and classify intracranial hemorrhage with high accuracy was substantiated in research presented at the 2018 Society for Imaging Informatics in Medicine (SIIM) annual meeting, according to the company.

HealthICH is part of Zebra's multimodality AI triage technology that also includes Zebra's HealthPNX, an AI algorithm for detecting pneumothorax on x-rays.

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