FDA Clears New Sensors for Anesthesia Monitor

The U.S. Food and Drug Administration (FDA) has cleared two new sensors for the Bispectral Index (BIS) line of anesthesia monitors. One is the BIS Pediatric Sensor and the second is the BIS Sensor XP (for expanded performance). Both sensors feature an improved design for easy connection, and enable the BIS system to automatically configure its settings for specific patient populations. The BIS Sensor XP will also offer enhanced performance in deep anesthetic states and improved robustness to interference from noise sources, such as high frequency conditions in the operating room and intensive care unit. The FDA also cleared the BIS Module Kit, a small printed circuit board that incorporates the BIS technology in monitoring systems produced by original equipment manufacturers (OEMs).

The BIS anesthesia monitors were developed by Aspect Medical Systems, Inc. (Newton, MA, USA). The monitoring systems provides clinicians with information that enables them to better assess and manage a patient's level of consciousness wherever anesthetics are administered, and provide the precise amount of anesthesia needed by each patient. Aspect Medical Systems has licensed the technology to a number of companies, including GE Medical Systems, Agilent Technologies, and Datex-Ohmeda.