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Medical Devices / Submissions and Approvals

FDA OKs Zebra Medical’s AI Triage Software for Intracranial Hemorrhaging

June 19, 2019
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Zebra Medical’s computer-assisted triage software has received 510(k) clearance from the FDA for identifying intracranial hemorrhages based on CT scans.

The radiological, machine learning-based software prioritizes and identifies time sensitive imaging for review by clinical users through image analysis, automatically detecting brain bleeds.

Intracranial hemorrhages account for about 10 to 20 percent of all strokes, and successful care for patients relies on fast and accurate diagnoses, the devicemaker noted.

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