Bio-Signal Group submits microEEG digital telemetry device to FDA, seeks participants for clinical trial

Biosignal Group (BSG) has submitted their microEEG technology to the FDA for approval so they can begin marketing the device for use as an all-in-one, disposable emergency department electroencephalogram (eEEG) digital telemetry system.

The microEEG System is a miniature, semi-disposable, wireless clinical platform technology capable of recording EEGs that is fast, portable, and easy-to-use.

BSG partnered with Mixer Design Group to design a truly impressive peripheral device for monitoring EEG data while presenting minimal invasiveness. microEEG has emerged as the clear leader in terms of wearable EEG Bluetooth amplifier design for the ambulatory and emergency department setting.

The system employs BSG-developed high-fidelity digital wireless electrophysiological recording technology which simplifies the recording process and makes EEG and its interpretation possible in scenarios which were previously not feasible.

The microEEG system enables up to 26 channels of digital EEG collection and includes a wireless data transfer device designed for use in ambulatory and hospital environments. The system digitizes analogue EEG signals collected by 3rd party electrodes, amplifies them, and using Bluetooth transfers the physiological data for EEG to a dedicated host computer.

BSG, founded by Andre Fenton, PhD, Professor of Neural Science at the Center for Neural Science at New York University, recently gave a detailed description of their eEEG solution in the International Journal of Emergency Medicine. microeeg_sideimage1_alt microeeg_sideimage2_alt microEEG software is the least touted element of the BSG solution, but from the screenshot on the company’s website it appears the data is available to clinicians via a web portal, which presents real-time and archived physiological data, allows remote adjustment of electrode amplitude, and clinician annotation of data for the patients personal health record (PHR). microeeg_signals_window_alt

microEEG Design

BioSignal_EEG_01_alt BioSignal_EEG_04_alt BioSignal_EEG_05_alt

BSG Funding

The company has received over $5M in grants to support the commercialization of their technology. Upon receiving FDA approval, its reasonable to assume the promising start-up will be able to raise substantial venture capital to support the manufacture and distribution of its product across the country.

Clinical Trial

Bio-Signal is currently recruiting participants for a clinical trial of the microEEG digital telemetry system. All study participants will undergo EEG using two devices (standard EEG and microEEG) and a combination of electrodes and Electro-Cap in a randomized order: (1) Standard EEG with standard EEG electrodes; (2) microEEG with standard EEG electrodes; (3) microEEG with Electro-Cap electrodes.

The objective of the trial is to compare the accuracy of EEG recordings and interpretations of microEEG to those of standard EEG, allowing investigators to assess the utility of the novel device in the Emergency Department patients with altered mental status. Research sponsors and collaborators include the National Institute of Neurological Disorders and Stroke (NINDS), State University of New York – Downstate Medical Center and Kings County Hospital.

Further Reading

“Diagnostic Utility of Emergency Electroencephalogram In Identifying Non-convulsive Seizure and Subclinical Status Epilepticus in Patients with Altered Mental Status” – ClinicalTrials.gov Product Page – microEEG Andre Fenton – PBS Nova Feature

Author:

Brian Edwards

Senior mHealth Analyst

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