Free Demo EEG Portal

The FIRST critical care monitoring device and neurodiagnostic device to achieve both

The first critical care monitoring device and neurodiagnostic to achieve both FDA Breakthrough Designation and an exclusive New Technology Add-on Payment (NTAP) code from CMS.

ClarityPro is an artificial intelligence-based software algorithm that analyzes EEG waveforms to diagnose electrographic status epilepticus. The ClarityPro algorithm offers continuous monitoring of patients for potential seizure activity, providing both bedside and remote clinicians with vital real-time data. The advanced software enables swift identification and treatment of seizures, as well as guides precise medication management.  

Efficient and Actionable EEG Reads  

With ClarityPro, the Ceribell solution allows hospitals to efficiently expand their brain monitoring capabilities to acute care departments, at a fraction of the cost of conventional EEG. 

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ClarityPro  Resources

FDA Breakthrough Devices Program

The FDA Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.   

Breakthrough Devices must meet the FDA's rigorous standards for device safety and effectiveness, including providing for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions and offering significant advantages over existing approved or cleared alternatives.

ClarityPro is now the only FDA-indicated device for the diagnosis of ESE in adult patients over the age of 18. Moreover, this is the first time in a decade that the FDA granted a diagnosis designation to an acute care device.  

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New Technology Add-on Payment

The New Technology Add-on Payment (NTAP) is a Medicare reimbursement program that financially assists healthcare organizations when they adopt new technology and is part of the CMS Inpatient Prospective Payment System (IPPS). CMS grants New Technology Add On Payments (NTAPs) to breakthrough devices to stimulate the use of new technology.​ Only traditional Medicare beneficiaries are eligible for NTAP reimbursement. 

Receiving NTAP is further validation of ClarityPro’s clinical impact, as NTAP eligibility requires: 

1) Newness: A technology is considered new until the claims data becomes available (typically up to 3 years after FDA approval) and so long as it is not “substantially similar” to existing technology 

2) Cost: The technology must be inadequately paid under the existing MS-DRG system

3) Substantial Clinical Improvement: Use of the technology must significantly improve clinical outcomes  for a specified patient population, compared to currently available treatments 

NTAP approval for additional reimbursement for eligible Medicare patients became effective on October 1, 2023. Additional reimbursement (NTAP) per eligible patient is exclusive to ClarityPro.  

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ClarityPro Feature Updates

ClarityPro is an updated algorithm package designed to enable more efficient patient diagnosis and management, making it possible for even the busiest of hospitals to provide comprehensive care for suspected seizure patients.

There are three key new features with ClarityPro:   

  • Bedside ESE Diagnosis
  • Make confident treatment decisions with a clinically validated AI detection algorithm that diagnoses electrographic status epilepticus
  • Insights Bar
  • Quickly identify more patients in need of care with an automated insights bar located within the EEG portal that highlights additional areas of potential concern beyond seizure burden detection 
  • Live Recordings Dashboard
  • Limit time in status with vital real-time monitoring for up to 5 patients simultaneously

Insights Bar

Live Recordings Dashboard

Bedside ESE Diagnosis


ClarityPro aligns with both NCS and ACNS guidelines, enabling your hospital to comply with the latest recommendations and standards of care.

2012 NCS Guidelines

To minimize the amount of time a patient is in status epilepticus, the Neurocritical Care Society defines status epilepticus as 5 minutes or more of continuous clinical and/or electrographic seizure activity. The primary bedside alarm for ClarityPro alerts in accordance with these guidelines. 

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2021 ACNS Guidelines

The American Clinical Neurophysiology Society redefined Electrographic Status Epilepticus in 2021 as 10 continuous minutes of seizure OR 12 minutes of seizure activity in the last 60 minutes. Ceribell is the first and only company to diagnose Electrographic Status Epilepticus according to ACNS guidelines.   

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Electrographic Status Epilepticus (ESE)

ESE is a life-threatening condition that is associated with significant increases in morbidity and mortality. If left uncontrolled, negative outcomes for ESE (including permanent disability or death) are significantly increased.

Outcomes for patients with ESE are strongly tied to how quickly the condition is recognized and controlled. Furthermore, efficacy of first line treatments decreases as seizure duration increases further emphasizing the critical need for rapid detection of ESE.¹

The ability to diagnose ESE is essential to detecting status epilepticus. Neurocritical Care Society guidelines recommend that SE should be controlled within 1 hour of onset.²

Despite these challenges, early diagnosis and management of SE have been shown to dramatically improve patient outcomes.³  

SE affects up to approximately 200,000 or more Americans each year​.4-6

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  1. JP Betjemann et al. (2015) Lancet Neurol. 14(6):615-24
  2. Ascoli, M.,et al. (2021) Int J Gen Med. 14: 2965–2973
  3. Gainza-Lein, M, et al. (2019) Seizure. 68:22-30
  4. Dham, BS., et al (2014) Neurocrit Care. (3):476-83
  5. DeLorenzo, R. J., et al. (1996) Neurology. 46 (4) 1029-1035
  6. Lu, M., et al (2020) Epilepsy Behav. 112:102459

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