BrainScope Ahead 100
BRAINSCOPE COMPANY, INCThe BrainScope Ahead 100 is a portable EEG-based device designed to assist physicians in evaluating patients with mild traumatic brain injury. It analyzes brain electrical activity to help decide if a head CT scan is needed, potentially reducing unnecessary CT scans and radiation exposure. The device processes EEG data using AI-driven algorithms to classify patients based on the likelihood of structural brain injury visible on CT.
Intended Use
Aid in evaluation of patients considered for head CT following mild traumatic brain injury with GCS 13-15 within 24 hours of injury, age 18-80, as adjunct to clinical practice, not a substitute for CT.
Technology
Portable EEG system with electrode headset collecting frontal EEG signals; proprietary software performs artifact reduction, quantitative EEG feature extraction (Absolute and Relative Power, Asymmetry, Coherence, Fractal Dimension); applies an AI algorithm to generate a classification indicating likelihood of structural brain injury visible on CT; provides results on a handheld touch-screen interface.
Performance
Bench testing demonstrated device performance including EEG signal measurement, artifact reduction, feature calculation, and classification algorithm repeatability and reliability. Clinical study with 552 patients showed sensitivity of 78.5%, specificity of 48.6%; negative predictive value 89.5%, indicating utility as adjunctive aid but not a stand-alone diagnostic. No adverse device events reported.
Device Timeline
- 1
Submission
8/20/2014
2 months - 2
FDA Approval
11/17/2014
Other devices from BRAINSCOPE COMPANY, INC
- BrainScope TBI2019 • 510K
- Ahead 3002016 • 510K
- Brainscope Ahead 2002015 • 510K
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.