Ceribell’s Status Epilepticus Software Receives FDA Clearance With CMS NTAP Coverage Included

This article was originally published in Neurology Live. It has been lightly edited.

The FDA has granted 510(k) clearance to Ceribell’s new software, ClarityPro, for the diagnosis of electrographic status epilepticus (ESE) in adults over the age of 18, becoming the first such tool available. Subsequently, CMS gave new technology add-on payment (NTAP) for ClarityPro for up to $913.90 per eligible Medicare patient case.

The study is published in Neurocritical Care.¹

This point-of-care electroencephalogram (EEG) system delivers real-time seizure monitoring with around-the-clock alerts, enabling more precise treatment of patients with suspected nonconvulsive seizures. The only such device to diagnose ESE according to the American Clinical Neurophysiology Society definition of ESE, ClarityPro utilizes a machine learning algorithm to analyze EEG signals and generate bedside alerts.

"These decisions from the FDA and CMS are further validation that Ceribell's clinical impact is significant for patients," said Jane Chao, PhD, cofounder and CEO at Ceribell, in a statement.² "This dedicated reimbursement from CMS will also expand access to this vital technology to more Americans, especially seniors and critically ill patients who are more likely to suffer from neurological illnesses."

With the decision, ClarityPro becomes the first and only intensive care unit monitoring device to receive CMS NTAP reimbursement, which is expected to become available on October 1, 2023. The idea behind ClarityPro is that it will streamline the EEG review process by flagging all portions of the EEG that could contain seizures or other areas of concern, enabling more faster and more confident triage. Prior to its approval, it received breakthrough device designation.

The clinical impact of Ceribell with Clarity was on display in a 2021 retrospective study featuring 353 patients who underwent evaluation of possible seizures. Otherwise known as the CLARITY study, the trial spanned across 6 US hospitals with 1052 hours of EEG examined. A majority of the neurologists labeled the EEGs as normal or slow activity (n = 249), highly epileptiform patterns (HEP; n = 87), or seizures (n = 17; 9 longer than 5 minutes and 8 shorter than 5 minutes).

Findings showed that Clarity detected more than 90% of the seizure burden, thereby triggering an alert for impending status epilepticus, in 9 out of 9 cases, equating to 100% sensitivity. Of the 179 EEG recordings in which Clarity detected no seizures, seizures were identified by the expert reviewers in only 2 cases. In both cases, the seizures were less than 30 seconds in duration, indicating a negative predictive value of 99%.

Jane Chao, PhD

In the study, the specificity of seizure burden notification more than 90% was 93.0%, resulting in a false detection for 24 of 353 EEGs. In 21 (87.5%) of these false detections, the expert consensus categorization of the EEG was HELP, indicating that there was concerning epileptiform activity present in the record, even if no unequivocal seizures were agreed to be present by both reviewers.

When the 4 reviewers' identifications of status epilepticus were compared with the majority consensus, individual expert rates displayed variability in both sensitivity (range, 20%-89%) and specificity (range, 94%-99%). Each expert reviewed a different subset of the 353 total recordings. Overall, the experts displayed greater specificity compared with Clarity, and each of the reviewers misclassified at least 1 case of status epilepticus.

"Claritγ provides highly sensitive detection of status epilepticus and may be useful as a risk stratification tool that could expedite diagnosis and treatment of patients with nonconvulsive seizures," wrote the researchers of the study. "We believe that machine learning tools will never replace a careful history and examination filtered through a well-honed clinical acumen of the user and recommend its safe use by interpreting its output in the context of proper clinical judgment."

References

1. Kamousi B, Karunakaran S, Gururangan K, et al. Monitoring the burden of seizures and highly epileptiform patterns in critical care with a novel machine learning method. Neurocritical Care. 2021;34(3):908-917. doi:10.1007/s12028-020-01120-0

2. Ceribell recieves FDA 510(k) clearance and CMS NTAP reimbursement for New ClarityPro Software with electrographic status epilepticus diagnostic indication. News release. Ceribell. August 3, 2023. Accessed August 4, 2023. https://www.prnewswire.com/news-releases/ceribell-receives-fda-510k-clearance-and-cms-ntap-reimbursement-for-new-claritypro-software-with-electrographic-status-epilepticus-diagnostic-indication-301892676.html