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January 5, 2026
Ceribell’s LVO Stroke Detection Monitor Receives FDA Breakthrough Device Designation
January 5, 2026—Ceribell, Inc. announced that the FDA has granted Breakthrough Device designation for its large vessel occlusion (LVO) stroke detection monitor for patients in the hospital setting. The company stated that the device uses Ceribell’s existing hardware and applies an artificial intelligence–based algorithm to interpret electroencephalogram signals for early detection of LVO stroke.
“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,” commented Chitra Venkatasubramanian, MD, in Ceribell’s press release.
Dr. Venkatasubramanian, Clinical Professor of Neurology and Neurosurgery at Stanford University in Stanford, California, continued, “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.”
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