The FDA Clears an EEG Point-of-Care Tool To Help Identify Seizures and Status Epilepticus

The Food and Drug Administration (FDA) has granted 510(k) clearance to BrainWatch (Natus, Middleton, WI), an electroencephalography (EEG) decision support tool device, designed to rapidly identify nonconvulsive seizures and status epilepticus at point-of-care. Natus debuted BrainWatch at the American Epilepsy Society (AES) 2024 Annual Meeting.

BrainWatch is designed to accelerate and streamline treatment decisions in acute care settings and utilizes Natus’ NeuroWorks EEG software platform, which facilitates remote collaboration among neurologists. Natus intends to partner with hospitals and healthcare facilities to gather feedback before the official launch of BrainWatch, which is scheduled for early 2025.

"BrainWatch is designed to bring the reliability and trust of Natus EEG solutions into critical care environments," said Chris Landon, CEO of Natus. "And, because of its ease of use, BrainWatch will make high-quality EEG accessible to people across more communities while enabling remote, expert neurologist consultation."