Medical device developer Neurosteer has obtained US Food and Drug Administration (FDA) approval for its single-channel electroencephalogram (EEG) brain monitoring platform.
The company has embellished the standard EEG system with an adhesive-backed electrode strip connected to a pocket-sized sensor.
The sensor accepts the signal from the electrode strip and transmits it to the brain activity monitor, which displays the status information alongside the most recently acquired signal.
Neurosteer’s EEG brain monitoring platform uses a single adhesive forehead strip and provides the traditional EEG frequency bands.
The device has also received FDA approval to include several new brain metrics visual representations.
This regulatory approval enables the use of the unobtrusive multi-purpose EEG System in a wide range of clinical settings.
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The device can continuously monitor the brain of a patient in an intensive care unit and enable the early detection of pre-symptomatic cognitive declines, such as Parkinson’s, Alzheimer’s and dementia.
In addition, the system can assist with the quick and cost-effective mass screening of participants in clinical trials for neurodegenerative disorders.
Neurosteer founder and CEO Dr Nathan Intrator said: “We are extremely pleased that the FDA has cleared our portable and affordable EEG system, and moreover, recognised the potential clinical value of our brain metrics visual representations.
“This is an important step in achieving our goal of making brain monitoring and assessment widely available to all populations.”
Neurosteer said that its single-channel EEG brain monitoring platform includes a non-invasive evaluation with auditory prompts that can help with the early detection of brain deterioration.
The brain monitoring system is currently being validated in clinical trials and used by pharmaceutical companies for patient screening and drug efficacy testing.
Dr Intrator founded Neurosteer in 2015 to commercialise brain monitoring technology that he had developed at Tel Aviv University.
The company has offices in New York, California and Israel.