Medical technology company Natus Medical Incorporated has submitted its latest point-of-care EEG system for FDA 510(k) clearance, the company announced on October 10, 2024. The device is designed to assist in the rapid identification of non-convulsive seizures (NCSs) and status epilepticus in critical care settings, such as emergency rooms and intensive care units.
The point-of-care EEG system aims to streamline treatment decisions by enabling fast intervention, a crucial factor in improving patient outcomes. The system incorporates Natus’ widely-used NeuroWorks software, which allows neurologists to review EEG data remotely via a secure, cloud-based platform, accessible 24/7 from any web browser. Natus has also partnered with Persyst, a leading provider of AI-powered seizure detection, to integrate advanced algorithms that are also under FDA review.
Healthcare professionals involved in early evaluations have praised the device for its ease of use and efficiency, noting that it can be set up within minutes by ER and ICU staff without the need for specialized EEG technologists. The system has also garnered positive feedback from neurologists for delivering clinical insights that exceed expectations.
As a leader in EEG neurodiagnostic solutions, Natus is leveraging its decades of experience to bring what it hopes will become the new standard for EEG use in acute care. If approved, the device could provide healthcare providers with a reliable tool to make life-saving decisions during critical moments in patient care.
