Ceribell Gets FDA Breakthrough Nod For Stroke Detection, Monitoring Solution

Ceribell has received FDA Breakthrough Device designation for its large vessel occlusion (LVO) stroke detection and monitoring solution, marking another step in the expansion of its point-of-care EEG brain monitoring platform. The designation applies to use of the AI-powered system in hospital settings and is intended to speed development and regulatory review of technologies addressing serious, unmet medical needs.

The Sunnyvale, California–based company built the stroke solution on its existing EEG hardware, using an AI algorithm to interpret brain signals for early detection of LVO strokes. These strokes are medical emergencies associated with significantly higher morbidity and mortality than other ischemic strokes, where faster diagnosis and treatment can dramatically improve long-term outcomes. Ceribell’s system is designed to enable more timely and continuous neurological monitoring at the bedside.

The breakthrough designation follows recent regulatory momentum for Ceribell, including FDA clearance for a continuous delirium monitoring solution and earlier clearance for a next-generation neonatal seizure monitoring algorithm. The platform already supports continuous monitoring for seizures, electrographic status epilepticus, and delirium. CEO Jane Chao emphasized that in-hospital stroke patients often face critical delays in care, and said the FDA’s recognition underscores the potential of Ceribell’s technology to deliver faster, more accurate LVO stroke detection. The milestone builds on the company’s FDA clearance for a pediatric seizure algorithm in 2025 and its IPO in 2024.