IBT announces first FDA-approved neurodiagnostic device

August 27, 2008

BALTIMORE, MD – Infinite Biomedical Technologies’ (IBT) first neurodiagnostic device, the I-2000 Monitor, has been cleared for marketing by the U.S. Food and Drug Administration under section 510(k) of the FD&C Act.

With years of experience in medical instrumentation and signal processing, engineers at IBT are creating products tailored to Emergency Departments (EDs) and Intensive Care Units (ICUs). Each year more than 4,800 EDs and 6,000 ICUs in the U.S. see millions of patients at risk of seizures and brain injury, which if left undetected, can lead to severe neurological damage. Detecting seizures and brain injury can be done with an electroencephalogram (EEG), a test that measures the brain’s electrical activity. However, currently available EEG monitors are commonly underutilized due to logistical hurdles (lacking ease of use and rapid availability).

IBT is creating solutions to this address this problem by developing user-friendly EEG technologies for clinical use by health care personnel including ED & ICU physicians and nurses. The I-2000 Monitor is intended to monitor the state of the brain by acquisition of electroencephalogram (EEG) signals. It provides raw EEG data as well as quantitative information such as power spectrum and spectral edge frequency. The I-2000 system wirelessly collects 2-channels of EEG signals and requires only five electrodes, significantly reducing electrode application and setup time.

Research and development is underway to provide automated seizure detection and brain injury analysis on any EEG product platform. Additionally, IBT plans to incorporate remote monitoring of patient EEG data from any location to allow expert review by specialists. The company will market these future products for clinical use upon regulatory review and receipt of FDA clearance as required.