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BioWorld - Saturday, December 6, 2025
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Home » Ceribell scores win with FDA clearance of bedside Claritypro
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Ceribell scores win with FDA clearance of bedside Claritypro

Sep. 6, 2023
By David Godkin
At the same time it reported U.S. FDA clearance for bedside software to diagnose electrographic status epilepticus (ESE) seizures, Ceribell Inc. declared Claritypro the first ICU monitoring device to receive an NTAP reimbursement from the Centers for Medicare and Medicaid Services. The clearance of Claritypro to diagnose ESE follows receipt of an FDA breakthrough device designation in two different categories in the past year, setting the stage, Ceribell CEO Jane Chao told BioWorld, for expanded access to critical seizure diagnosis technology.
BioWorld MedTech Neurology/psychiatric Diagnostics Artificial intelligence Monitoring Digital health

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