Ceribell Delirium Monitoring System Earns CMS NTAP

Ceribell has been 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).

This reimbursement win comes after December’s U.S. Food and Drug Administration (FDA) 510(k) clearance for the Sunnyvale, California-based company’s Ceribell system. The company touts it as the first and only FDA-cleared device to aid in delirium screening and monitoring.

The system continuously analyzes EEG segments and alerts clinicians when it flags patterns related to delirium. It’s built on Ceribell’s existing, FDA-cleared tech to detect nonconvulsive seizures and electrographic status epilepticus (ESE) and merges seizure and delirium monitoring into one system. Ceribell simultaneously tracks multiple neurological vital signs at the bedside, providing diagnostic insights without requiring separate devices.

The add-on payment will take effect on October 1.

“We believe that CMS’ NTAP decision underscores the profound clinical necessity and transformative value of our point-of-care technology for critically ill patients,” said Jane Chao, Ph.D., co-founder and CEO of Ceribell. “The add-on payment will help facilitate widespread commercial access to this vital innovation for a highly vulnerable patient population. This marks a pivotal milestone in our strategic mission to establish EEG as an essential new vital sign for better brain care.”

Earlier this year, the company’s large vessel occlusion (LVO) stroke detection monitor for patients in the hospital setting earned FDA breakthrough device status.