CeriBell, Inc. (NASDAQ:CBLL) shares climbed 8% on Monday after the company said it had received Breakthrough Device Designation from the U.S. Food and Drug Administration for its Large Vessel Occlusion (LVO) stroke detection monitor.
The designation applies to CeriBell’s first-in-class LVO stroke detection solution, which leverages the company’s existing hardware combined with an AI-driven algorithm to analyze EEG signals for early identification of LVO stroke in hospital settings. If ultimately cleared, the Ceribell System would become the first point-of-care electroencephalography technology designed to assist clinicians with the detection and monitoring of LVO stroke in hospitals.
The milestone reflects CeriBell’s broader strategy to extend its point-of-care EEG brain monitoring platform into additional clinical indications. Recently, the company secured FDA 510(k) clearances for its next-generation Clarity algorithm for detecting electrographic seizures in neonates in November 2025, followed by clearance in December 2025 for its proprietary delirium screening and monitoring technology.
LVO strokes account for an estimated 62% of post-stroke dependence and 96% of post-stroke deaths, making rapid diagnosis and treatment critical. Research has shown that strokes occurring in hospitalized patients are often identified and treated far later than those that occur outside hospital settings, contributing to poorer outcomes.
“At a time when minutes matter, patients with in-hospital stroke often experience hours of delay,” said Jane Chao, Ph.D., co-founder and CEO of CeriBell. “Ceribell is proud that this FDA Breakthrough Device Designation recognizes the potential of the Ceribell System to provide accurate and timely detection of LVO stroke for this vulnerable patient population.”
CeriBell said its technology is designed to address the difficulty of recognizing strokes in hospitalized patients, particularly outside neurological units where staff may not have specialized training to spot subtle neurological deterioration.