Ceribell receives FDA Breakthrough Device Designation for LVO stroke detection system

Ceribell, Inc.

FDA Breakthrough Device Designation granted for CeriBell's LVO stroke detection and monitoring solution.
First-in-class point-of-care EEG technology using existing hardware and AI algorithm to interpret signals.
Nearly 800,000 annual US strokes; LVO strokes cause 62% of post-stroke dependence and 96% of mortalities.
Designation supports potential expedited development; follows recent 510(k) clearances for Clarity and delirium screening.
Targets in-hospital stroke patients, where detection and treatment delays lead to 3x higher mortality.

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