Devices & Diagnostics

FDA Clearance Spotlight: Ceribell

Ceribell Inc., based in Sunnyvale, California, has developed a point-of-care EEG system that provides real-time seizure monitoring and alerting, which helps in the rapid and precise treatment of patients with suspected non-convulsive seizures. The FDA-cleared Ceribell ClarityPro software uses a machine-learning model to analyze EEG signals and generate bedside alerts.

Name of Company: Ceribell Inc

Rafael Donnay, vice president of product and reimbursement at the Sunnyvale, California, company, describes the details of the FDA clearance of the ClarityPro software system.

Name of the Product:

When did you receive the clearance?:
May 23, 2023

Describe the problem that the product addresses:
Diagnosis of ESE (Electrographic Status Epilepticus) is essential to treating prolonged seizures, which may affect one-third of hospitalized neurological critical care patients. These seizures increase the risk of permanent brain injury. Early diagnosis & management can dramatically improve patient outcomes. ClarityPro is now the first and only device to diagnose ESE according to the American Clinical Neurophysiology Society’s definition of ESE.

Who is the end-user?:
Healthcare providers in ICUs and Emergency Departments

Does the product need reimbursement and is it covered?:
Additional Medicare reimbursement will 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 this approval, hospitals can receive NTAP reimbursement of up to $913.90 for eligible Medicare patients starting in October 2023.

What are the competitive products on the market?:
Zeto Wireless EEG Headset

Photo: jayk7, Getty Images and Ceribell

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