Natus Medical announced it has submitted an FDA 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its Natus point-of-care EEG device.
The tool is designed to help identify non-convulsive seizures (NCSs) and status epilepticus in acute care environments, supporting rapid intervention and streamlining treatment decisions to improve patient outcomes.
This point-of-care EEG system uses Natus' NeuroWorks software platform to provide a review experience with remote neurologist collaboration, 24/7 from any web browser.
Natus has partnered with Persyst, a developer of spike and seizure detection, to incorporate AI-powered seizure detection algorithms, also under review for FDA clearance.
Early feedback promotes an easy-to-use system that can be deployed in minutes by ER and ICU staff without the need for an EEG technologist and with clinical information exceeding the expectations of neurologists.
