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Ceribell's ClarityPro™ Software Granted FDA 510(k) Clearance and CMS NTAP Reimbursement for Electrographic Status Epilepticus Diagnostic Indication

Friday, August 04, 2023

Ceribell has recently announced that its ClarityPro software has received FDA 510(k) clearance for diagnosing Electrographic Status Epilepticus (ESE). Prior to this clearance, the software had already obtained Breakthrough Device Designation from the FDA, which expedites the review process for new technologies meeting high standards to benefit patients and healthcare providers.

Furthermore, the U.S. Centers for Medicare and Medicaid Services (CMS) has granted New Technology Add-on Payment (NTAP) for ClarityPro, This recognition makes ClarityPro the sole FDA-indicated device for diagnosing ESE in adult patients over 18 years old and the first to receive NTAP reimbursement for ESE diagnosis.

The diagnosis of ESE holds significant importance as prolonged seizures can affect a considerable number of neurological critical care patients during their hospital stay, posing the risk of permanent brain injury and long-term neurological disability. Early diagnosis and proper management have shown to significantly improve patient outcomes.

To diagnose ESE, Ceribell's ClarityPro software utilizes a machine learning model that analyzes EEG signals and generates bedside alerts. This empowers bedside clinicians to make quick and confident decisions, streamlining the EEG review process by identifying portions of the EEG that may contain seizures or other areas of concern, thus enabling faster and more reliable triage.

In addition to its FDA indication, ClarityPro stands as the first and only device to diagnose ESE based on the definition set forth by the American Clinical Neurophysiology Society (ACNS), raising the bar for EEG analysis. While neurologists will still review all EEGs for the presence of other pathological EEG patterns, ClarityPro significantly aids in expediting the process and enhancing diagnostic accuracy.



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