Ceribell announced that its new software ClarityPro has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE).

ClarityPro is now the only FDA-indicated device for the diagnosis of ESE in adult patients over the age of 18. ClarityPro is also the first and only device to offer NTAP reimbursement for the diagnosis of ESE.

The clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent to receiving Breakthrough Device Designation and 510(k) clearance from FDA, the U.S. Centers for Medicare and Medicaid Services (CMS) granted New Technology Add-on Payment (NTAP) for ClarityPro of up to $913.90 per eligible Medicare patient case.

Ceribell’s ESE Diagnosis is the second Breakthrough Device Designation granted to the company in the past 12 months. ClarityPro is the first and only ICU monitoring device to receive CMS NTAP reimbursement, according to the company. NTAP reimbursement will become available on October 1, 2023.

“These decisions from the FDA and CMS are further validation that Ceribell’s clinical impact is significant for patients.” said Jane Chao, PhD, Ceribell’s co-founder and CEO. “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.”

The ability to diagnose ESE is essential to treating prolonged seizures, which may affect one-third of neurological critical care patients during their hospital stay. These seizures increase the risk of permanent brain injury with long-term neurological disability. Early diagnosis and management have been shown to dramatically improve patient outcomes.

Ceribell is a point-of-care EEG system that delivers real-time seizure monitoring and alerts 24/7, enabling rapid and more precise treatment of patients with suspected non-convulsive seizures. The new Ceribell ClarityPro software utilizes a machine learning model to analyze EEG signals and generate bedside alerts. The software, combined with the Ceribell system, empowers bedside clinicians to make decisions quickly and confidently.