Ambler, PA – August 26, 2014 – Moberg has received CE Mark approval for the CNS Monitor, a medical device used for advanced monitoring of neurological intensive care patients. The CE Mark certifies that a product has met European Union requirements for commercial marketing in Europe.
The CNS Monitor captures and analyzes multiple physiologic parameters including electroencephalography (EEG, or brain waves) to support neurological patient care. The monitor’s state-of-the-art, integrated displays support clinicians’ ability to make timely, life-saving care decisions. In particular, these integrated displays can reveal changes in intracranial dynamics which help in the prevention, early detection, and treatment of secondary neuronal injury.
The CNS Monitor received U.S. FDA clearance in 2008 and has become popular in neuroscience intensive care units throughout the United States. Initially, the CNS Monitor will be distributed in nine European countries. “The CNS Monitor has been used by neuroscience researchers and scientists in Europe for years,” commented President, Dick Moberg, “so naturally we are excited to offer the product in the clinical setting where it can substantially impact daily patient care.”
Acute neurological injuries and diseases are costly, complicated medical problems. Neurocritical care encompasses some of the most widespread and devastating global illnesses, including stroke, traumatic brain injury, brain tumors, and many other muscular, nerve and spinal disorders. To manage these difficult cases, neurocritical care physicians and nurses rely heavily on monitored data to detect changes in patients’ status. Moberg developed the CNS Monitor to meet the increasing need for more precise, detailed physiologic data from these patients.
Later this year, Moberg will provide CNS Monitors for the upcoming Center-TBI project taking place in several European countries. This clinical study will investigate traumatic brain injury (TBI) and post-traumatic stress with support from National Institutes of Health, U.S. Department of Defense, and European Commission. The studies will result in databases available to all researchers, which will be particularly valuable for those studying diseases with similar biological characteristics.