Ceribell has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to its large vessel occlusion (LVO) stroke detection monitor for patients in the hospital setting. This “first-in-class” LVO stroke detection monitor uses Ceribell’s existing hardware and applies an artificial intelligence (AI)-based algorithm to interpret electroencephalography (EEG) signals for early detection of LVO stroke, according to a press release from the company.
Eventual clearance for this indication would position the Ceribell system as the “first and only” point-of-care EEG technology to aid in detecting and monitoring LVO stroke in the hospital setting, the release adds.
“In-hospital strokes frequently occur in units that aren’t specialised in neurology, where bedside teams may not have sufficient training or tools to detect subtle neurological changes concerning a stroke,” said Chitra Venkatasubramanian (Stanford Health Care, San Jose, USA). “Many of these patients are recovering from surgery, intubated, ventilated, or on medications that complicate their assessment, making it incredibly difficult to spot the early signs of a stroke. A tool that continuously monitors brain function and alerts the care team the moment something is wrong would allow us to intervene sooner and facilitate achieving better outcomes for patients.”
This Breakthrough Device designation recognises the potential of Ceribell’s LVO stroke detection monitor to enable timely and accurate LVO detection compared to the current standard of care, and is supported by validation from rigorous, prospective, multicentre studies using EEG data and clinical assessments.
“Stroke is a devastating condition, but one where quick access to treatment can make a lifetime of a difference,” said Jane Chao, co-founder and chief executive officer (CEO) of Ceribell. “At a time when minutes matter, patients with in-hospital stroke often experience hours of delay. Ceribell is proud that this US 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 Ceribell, the Breakthrough Device designation for LVO stroke represents the latest achievement in the company’s continued efforts to extend its point-of-care EEG brain monitoring technology to additional indications, building on recent US FDA 510(k) clearances for its next-generation Clarity algorithm to detect electrographic seizures in neonates, and its proprietary delirium screening and monitoring solution—both of which were announced in late 2025. The more recent LVO designation is another “critical milestone” that further reinforces Ceribell’s mission to make EEG “a new vital sign for better brain care”, the company also claims.
