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.
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
Efficient and Actionable EEG Reads
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.
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.
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:
A technology is considered new until the claims data becomes available
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.
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:
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.
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.
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
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