Ceribell wins FDA nod for algorithm to detect pediatric seizures

Ceribell has gained FDA 510(k) clearance to use its Clarity seizure detection algorithm on pediatric patients aged one year and older. Previously cleared only for adult use, the algorithm pairs with Ceribell’s portable EEG system to enable rapid, bedside seizure detection in critical care settings. This clearance enhances Ceribell’s ability to compete with traditional EEG systems, as the company aims to improve outcomes for critically ill children by enabling earlier diagnosis and treatment of non-convulsive seizures.

The clearance arrives amid broader business challenges for Ceribell, including a sharp drop in share price due to investor concerns about tariffs on Chinese imports. However, the company has sufficient inventory to weather the near-term impact and is exploring alternative manufacturing locations, such as Costa Rica, Mexico, or the U.S. Analysts have remained optimistic, calling the market reaction “overdone” and highlighting the potential for Ceribell’s continued growth, especially as it brings its pediatric algorithm to market.