Ceribell has obtained a breakthrough device designation for its large vein occlusion (LVO) stroke detection monitoring tool from the US Food and Drug Administration (FDA).
Using existing hardware from the company’s point-of-care electroencephalography (EEG) monitoring platform known as the Ceribell EEG System, which includes a 10-electrode headband and EEG recorder, LVO Stroke applies artificial intelligence (AI)-based algorithms to assess EEG signals for the early warning signs of LVO stroke in hospitalised patients.
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Following news of the FDA designation, Ceribell’s shares on the Nasdaq stock exchange rose to a market open of $22.48 per share on 5 January, reflecting a rise of around 4% on a $21.30 share value at market close on 2 January. Ceribell has a market cap of around $823m.
Ceribell said the breakthrough tag marks a continuation of its efforts to expand Ceribell EEG towards additional indications.
Ceribell EEG gained FDA clearance in 2017 and is currently cleared for delirium monitoring and seizure detection as facilitated by the company’s Clarity AI algorithm. In April 2025, Clarity also gained an additional indication for electrographic seizure monitoring in paediatric patients as young as one years old.
Ceribell’s CEO, Jane Chao highlighted that quick access to treatment can significantly impact stroke patient outcomes.
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By GlobalDataResearch indicates that around 800,000 strokes occur annually in the US, with early intervention a key factor towards positive patient outcomes. Of this number, between 35,000 and 75,000 strokes occur in hospitals and are associated with worse patient outcomes due to factors such as non-standardised guidelines and procedural measures hindering more timely interventions.
Chao said: “At a time when minutes matter, patients with in-hospital stroke often experience hours of delay. Ceribell is proud that this FDA [breakthrough device designation] recognises the potential of the Ceribell System to provide accurate and timely detection of LVO stroke for this vulnerable patient population.”
According to GlobalData analysis, the patient monitoring market is growing at a CAGR of 1.8% and forecast to reach a valuation of around $25.5bn in 2034.
