Ceribell Wins FDA Nod for AI Tools on Its Neurology Portal

Ceribell has received U.S. Food and Drug Administration (FDA) 510(k) clearances for two artificial intelligence (AI) enhancements integrated into its cloud-based Neurology Portal.

The first, Epileptiform Abnormality Detection, identifies sharp, abnormal brain wave patterns like spikes or sharp waves on an electroencephalogram (EEG). These signs help doctors diagnose epilepsy, find where seizures start in the brain, and guide critical-care treatment.

The second, Artifact Reduction, uses AI trained on a real-world artifact dataset to identify and reduce EEG artifacts, simplifying interpretation for neurologists and supporting point-of-care use. Beyond the simple filtering employed by traditional technologies, the new algorithm recognizes and identifies artifacts based on dedicated training on its own extensive real-world artifact dataset.

The Sunnyvale, California-based company hopes its enhanced Neurology Portal will tackle two huge EEG evaluation hurdles: filtering complex background interference and streamlining review of lengthy, ambiguous brain recordings.

The portal update builds on Ceribell’s POC system, which enables bedside monitoring in as little as five minutes. The enhancements integrate into existing workflows without software downtime or installation, the company said.

“With these new Neurology Portal enhancements, Ceribell continues to push the boundaries of AI innovation in neuromonitoring,” said Co-Founder/CEO Jane Chao, Ph.D. “This technology directly delivers on critical feedback from clinicians on the front lines. By automatically highlighting epileptiform patterns and isolating non-cerebral artifacts, we give valuable time back to neurologists. This empowers them to make fast, confident bedside decisions when every minute matters.”

Earlier this month, the company was granted a New Technology Add-on Payment (NTAP) for up to $2,171 per eligible Medicare case using its Delirium Monitor System by the U.S. Centers for Medicare & Medicaid Services (CMS).