The BrainPulse system consists of a headset, data collector and computer. The headset contains a heart rate detecting sensor (PPG), a Sound Pressure Level (SPL) sensor for detecting ambient environment noise and six accelerometers to detect the acceleration of the skull at six selected locations. These components are assembled in a compact and portable headset. A touchscreen tablet provides the user interface to the BrainPulse device and stores the proprietary files from each recording session.
The BrainPulse device is easy to use and allows operators to quickly acquire relevant data. A typical recording takes only three to five minutes and can be done by physicians, nurses, athletic trainers or other medically trained personnel in a variety of athletic, military, or hospital settings.
The BrainPulse has received de novo clearance from the FDA as a class II device for cranial motion measurement. Moving forward the BrainPulse technology will allow researchers to collect valuable data for clinicians to analyze, establishing the areas of greatest benefit for this emerging technology. Jan Medical is actively pursuing the development of algorithms capable of detecting and monitoring changes of the pulsatile motion of the brain apparent in concussed subjects with the goal to obtain FDA approval for an indication of use in this field.