An FDA pivotal trial of our hospital monitoring device is underway at multiple sites, following promising first-in-human pilot studies and foundational research.
Clinical Evidence for Sense Technology
First-in-Human ICH monitor trial
9 patients enrolled
600 hours of monitoring time
3600 SENSE scans performed
7 no expansion
100% correspondence of SENSE with CT results at 12 hours. No false positives/no false negatives.
First-in-Human Stroke differentiation trial
5 LVO*, 5 non LVO*, 5 ICH**
Study conducted at Good Samaritan Hospital and UC
5 LVO*(completed)
5 non-LVO* completed
5 ICH** completed
**Intracerebral hemorrhage (ICH)
Case Study: Hospital Monitoring
Patient data from our 2020 First-in-Human ICH monitor trial demonstrates Sense’s NeuSTAT™ non-invasive, continuous monitoring device detected a 3 ml expanded bleed five hours before it was detected through the current standard of care.
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The studies summarized are feasibility or early-stage evaluations. Results have not been reviewed by the U.S. FDA and do not imply device clearance or approval.
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NeuroHawk™ is an investigational device and is not yet cleared or approved by the U.S. Food and Drug Administration (FDA). It is not available for sale or clinical use in the United States. Information provided is for educational and investor purposes only.
