Emergency Brain Monitor with Telemetry
Department of Health and Human Services
Agency Tracking Number:
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Small Business Information
CLEVELAND MEDICAL DEVICES, INC.
4415 Euclid Ave, Cleveland, OH, 44103
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): This is a Phase II continuation proposal that is meant to provide for the brain what we have been doing for the heart for decades in the emergency department. During our prior work, we have developed and tested a compact telemetry EEG system that allows the patient to be untethered and moved about freely while still being monitored by a remote PC. We have conducted real time EEG monitoring in the Emergency Department (ED) at Beaumont Hospitals (Troy, Michigan) on twenty patients with altered mental status. The results show that the device is very practical and easy to use in that environment and does not impede conventional standard of care in the ED. As importantly, the results show that 7 of 20 patients had Non-Convulsive Seizures (NCS); abnormal brain activity that could have been totally missed using traditional procedures. Conflicting symptoms in two more patients were also resolved using our technology. In this proposal, we will finalize development and commercialization of the technology to produce the first wireless EEG device that is dedicated to the emergency room. We will upgrade the device with a new wireless transmitter (to meet recently issued FCC guidelines), repackage the review module to make it more rugged and reliable, and investigate faster hookup time by reducing the number of EEG electrodes. An extensive clinical trial will be conducted at Beaumont hospital emergency department in Troy, Michigan. The proposed device is needed in the market place and we hope will pioneer the wide-use of EEG in emergency rooms and in prehospital settings. Once recorded in the PC, real time EEG from the ED can be transferred via LAN and internet connections to a neurologist anywhere inside or outside the hospital. The device will also have an embedded seizure detection algorithm to facilitate neurological reading. Finally, while we recognize the potential resistance to changes in standard protocols, we believe that by commercializing this technology and with successful adoption even by few emergency centers will constitute a much needed step to convince the emergency doctors and hospital administrators nationwide of the importance of EEG as a critical complement to existing ED protocols.
* information listed above is at the time of submission.