Ceribell has secured a new FDA clearance for its point-of-care EEG headset system, covering software to help diagnose electrographic status epilepticus, or ESE—a potentially hidden condition where a brain seizure may not trigger any convulsive signs.
According to the former Fierce 15 winner, the agency’s green light makes the headset and its ClarityPro ICU monitoring software the first device to help diagnose ESE.
Ceribell previously received a breakthrough designation from the FDA in the indication—a ticket that has also helped it obtain reimbursement coverage through the U.S. Centers for Medicare & Medicaid Services’ New Technology Add-on Payment program, known as NTAP.
“These decisions from the FDA and CMS are further validation that Ceribell's clinical impact is significant for patients,” Jane Chao, Ceribell's co-founder and CEO, said in the company’s announcement. “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.”
Ceribell estimates that ESE and prolonged seizures may affect one-third of critical care patients hospitalized for a neurological condition. These seizures can also increase the risk of permanent brain injury and long-term neurological disability, the company said. Status epilepticus can happen in patients with a history of epilepsy, as well as those suffering from brain trauma, infections or strokes.
The headset and attached EEG recorder is designed to provide real-time monitoring of patients suspected of having non-convulsive seizures, while the new ClarityPro software employs a machine-learning model to analyze brain signals and deliver bedside alerts.
The FDA breakthrough designation for ESE marked the company’s second in the past year. Ceribell previously received a separate designation last September for detecting states of delirium, a sign of acute brain failure.
Ceribell’s point-of-care EEG system first received a 510(k) clearance in 2017 for suspected seizure activity.