Ceribell’s Neonatal US Clearance Sets Up 2026 Growth Amid China Pressures

FDA Clearance Points To NICU And Children’s Hospital Adoption.

The system’s algorithm operates in tandem with a dedicated headcap or headband. Ceribell secured 510(k) clearance for a pediatric headcap in 2023, followed by an additional clearance in October. Picture Courtesy: Ceribell

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