Nicolet EDX
Natus Neurology IncorporatedThe Nicolet EDX is a diagnostic system by Natus Neurology Incorporated that helps healthcare providers measure electrical activity in nerves and muscles through tests like nerve conduction studies, electromyography, and evoked potentials. It assists clinicians in assessing nervous system function, locating neural structures during surgery, and supporting diagnosis of neuromuscular conditions by recording and analyzing electrophysiological signals.
Intended Use
The Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).
Technology
The system consists of a base unit, amplifier (2 or 8 channel), control panels, computer with Natus Elite software, and optional audio, visual and electrical stimulators. It acquires electrophysiologic signals through electrical stimulators and records these signals via a digitized system with analog-to-digital conversion at 48 kHz sample rate. User interaction is via PC software and hardware control panels. The device provides multiple test modalities including nerve conduction studies, EMG, and evoked potentials with software driven workflows.
Performance
Verification and validation activities demonstrate that the Nicolet EDX is safe, effective, and substantially equivalent in performance to predicate devices. Performance testing included functionality verification, safety assessments, and software validation.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/23/2024
1 month - 2
FDA Approval
1/22/2025
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