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The 1ˢᵗ ICU monitoring device with

approved new inpatient code

for up to $913.90 per eligible patient

The first ICU monitoring device to achieve FDA Breakthrough Designation with an exclusive New Technology Add-on Payment (NTAP) from CMS

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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.

ClarityPro is now the only FDA-indicated device for the diagnosis of ESE in adult patients over the age of 18.

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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. 

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

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ClarityPro Feature Updates

New tools for neurologists provide more intuitive navigation of the seizure burden graph and additional insight into the EEG by automatically identifying other areas of concern.

American Clinical Neurophysiology Society (ACNS) Guidelines

Ceribell is the first and only company to diagnose Electrographic Status Epilepticus according to ACNS guidelines.

In 2021 ACNS releases updated guidelines redefining Electrographic Status Epilepticus as:

  • 10 continuous minutes of seizures OR
  • 12 minutes of Seizure Activity in the last 60 minutes

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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 ESE¹.

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 onset².

Despite these challenges, early diagnosis and management of SE have been shown to dramatically improve patient outcomes³.

The incidence of SE is 9-41/100,000=between 33,000 and 136,000 patients annually.

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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