Ceribell Unveils ClarityPro™ AI, Expanding Access to Vital Electrographic Status Epilepticus Diagnosis

Monday, October 30, 2023

Ceribell, Inc.® made a significant announcement today with the official release of its groundbreaking AI algorithm, ClarityPro™, alongside the potential availability of reimbursement for eligible Medicare patients. ClarityPro stands as a remarkable AI-driven software algorithm integrated into the Ceribell EEG system, designed to analyze EEG waveforms for diagnosing electrographic status epilepticus (ESE). It's a notable achievement as it becomes the first acute care device with FDA approval for stand-alone diagnosis.

Furthermore, it's also the pioneer among critical care monitoring devices to secure both FDA Breakthrough Designation and New Technology Add-on Payment (NTAP) reimbursement from the Centers for Medicare & Medicaid Services (CMS), underscoring its superior clinical benefits for patients suspected of having seizures. Using a unique code, hospitals may now be eligible for reimbursement of up to $913.90 per qualifying Medicare patient when utilizing this innovative technology.

ClarityPro offers continuous monitoring of patients' brain activity, especially for suspected seizures, with the capability to diagnose and issue alerts for ESE. This empowers clinicians both at the patient's bedside and remotely with essential real-time data required for swift identification and treatment of seizures and for assessing the efficacy of seizure medication. The automated cues provided by ClarityPro pinpoint critical areas within the EEG, supplying invaluable insights that assist neurologists during EEG evaluations and facilitating rapid responses when an escalation of care is necessary.

Importantly, the Ceribell system not only enhances brain monitoring capabilities in acute care settings but does so at a significantly lower cost compared to conventional EEG systems. Simultaneously, it contributes to reducing unnecessary medication use, intubations, patient transfers, and shortening ICU stays, all of which are crucial factors when dealing with status epilepticus. Ceribell remains committed to its mission of broadening access to neurodiagnostics, recognizing their pivotal role in advancing patient care and outcomes.


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