June 29, 2007 — Aspect Medical Systems, Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BIS VIEW Monitoring system, the company’s newest stand-alone monitor.
The BIS VIEW offers customers a compact design and simplified operation for lower acuity clinical environments with limited room for monitoring equipment.
According to the new indication for use statement cleared by the FDA, BIS monitoring may be used as an aid in monitoring the effects of certain anesthetic agents and may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time.
Use of BIS monitoring to help guide anesthetic administration may also be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation.
Using a sensor placed on the patient’s forehead, BIS monitoring translates information from the electroencephalogram (EEG) into a single number that represents each patient’s level of consciousness.
This number – the BIS value – ranges from 100 (indicating an awake patient) to zero (indicating the absence of brain activity). Using the BIS value to guide administration of anesthetic medication, clinicians can make informed decisions for optimal anesthesia or sedation.
For more information: www.aspectmedical.com