Ceribell has received U.S. Food and Drug Administration (FDA) breakthrough device status for its large vessel occlusion (LVO) stroke detection monitor for patients in the hospital setting.

The LVO monitor uses the company’s existing hardware and applies an artificial intelligence (AI)-based algorithm to interpret EEG signals for early detection of LVO stroke.

This Breakthrough Device Designation represents the latest achievement in the company’s efforts to extend its point-of-care EEG brain monitoring tech to additional indications. It builds on recent 510(k) clearances for its next-gen Clarity algorithm to spot electrographic seizures in neonates and its proprietary delirium screening and monitoring solution.

LVO strokes are medical emergencies and has much higher morbidity and mortality compared to non-LVO ischemic stroke, contributing to about 62% of post-stroke dependence and about 96% of post-stroke mortalities.

Unlike community-onset stroke, which occurs outside the hospital and often triggers immediate emergency response, in-hospital stroke affects patients who are already admitted. Scientific literature shows that stroke detection and treatment in hospitalized patients are often significantly delayed compared to strokes occurring outside of hospitals.

“In-hospital strokes frequently occur in units that aren’t specialized in neurology, where bedside teams may not have sufficient training or tools to detect subtle neurological changes concerning a stroke,” said Dr. Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS, Clinical Professor of Neurology and Neurosurgery. “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.”

The breakthrough status recognizes the Ceribell LVO stroke detection monitor’s potential to enable timely, accurate LVO detection compared to the current standard of care, the company said. It was supported by validation through rigorous, prospective, multi-center 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, Ph.D., co-founder and CEO of Ceribell. “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 recognizes the potential of the Ceribell System to provide accurate and timely detection of LVO stroke for this vulnerable patient population.”