Nurochek-Pro System
Headsafe MFG Pty LtdThe Nurochek-Pro System is a portable EEG-based device that generates visual evoked potentials to help healthcare professionals diagnose mild traumatic brain injury (mTBI) in patients aged 12 to 44. Worn on the patient's head, it records brain electrical activity and provides an analytic aid to detect mTBI within 5 days after a potential head injury, improving diagnostic accuracy in clinical settings.
Intended Use
Aid in diagnosis of mild traumatic brain injury (mTBI) in subjects aged between 12 and 44 years using visual evoked potentials (VEP) and EEG analysis within 120 hours of potential head injury.
Technology
Portable system with wearable headset to generate VEPs and record EEG, software application for acquisition, transmission, display, and storage of EEG data, and use of a classification algorithm comparing EEG readings to a normative database to aid mTBI diagnosis.
Performance
Clinical testing demonstrated sensitivity of 85.51% and specificity of 67.05% versus licensed healthcare professional diagnosis for mTBI detection. Testing also included biocompatibility, software verification, and electromagnetic safety standards compliance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/4/2024
4 months - 2
FDA Approval
3/27/2025
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.