BrainScope ZOOM-100DC, a handheld device for people with possible traumatic brain injury, has won FDA clearance.
The 8-channel product, capable of recording and displaying EEG waveforms and providing conventional EEG measures displayed in tables, is designed especially for those patients who don't have access to a hospital, for example, soldiers on the battlefield, athletes, and accident victims.
The ZOOM-100DC is intended to monitor the state of the brain by acquisition and display of electroencephalogram signals, the Washington, D.C company says. The touch screen is ergonomic, with easy to read displayers. Raw EEG waveforms can be displayed in both real-time and playback mode.
Not for Sale Yet
Although the device has won FDA clearance, the EEG is not for sale yet and has not been priced, Christa Ballog, director of product management, tells DOTmed News. She says the company is continuing to test the handheld EEG in clinical trials.
Commenting on development of this first-generation, TBI device, BrainScope CEO, Michael Singer, says that FDA approval is "an important step for us as we further develop our technology... to create a second device that is more sophisticated, robust and portable for traumatic brain injury."
He adds, "We are working hard to develop this next generation technology to provide a reliable, rapid and objective adjunctive assessment of potential TBI for use in triaging patients, particularly in the military where the need is so high."
BrainScope's novel application of advanced mathematics and miniaturized hardware is designed to bridge the limitations of traditional EEG tools, which are bulky, expensive, and require expert data interpretation, he says.
BrainScope is a privately held, neurotechnology company developing a new generation of portable, simple-to-use, non-invasive instruments to rapidly assess brain function at the initial point of care.
The portability and ease-of-use of these tools in development could aid United States military Health Service Support personnel in promptly diagnosing traumatic brain injuries that require rest and/or other treatment and removal from environments at risk for repeat brain injury, the company says.
According to the CDC, about 75% of TBIs are mild in nature , and routinely go unnoticed until further damage occurs, which often does not appear until weeks after the injury is sustained.
It is not uncommon for a mild "mTBI" or "concussion" to go undiagnosed or misdiagnosed. Because time to treatment is of upmost importance in mTBI, Brainscope's goal is to provide medical professionals with new, rapid, effective analysis tools to assist in the assessment of brain function, the company says.
Brainscope is backed by Revolution LLC (the investment arm of AOL co-founder Steve Case), ZG Ventures and Alafi Capital.
Read more in DOTmed's Press Room.