08.25.14
CAS Medical Systems Inc. (CASMED), a developer of medical devices for non-invasive patient monitoring, has won U.S. Food and Drug Administration clearance of an expanded label claim for the company's Fore-Sight Elite oximeters for use in non-cerebral tissue of adults.
The clearance permits Fore-Sight Elite oximeters to be marketed to clinicians to determine oxygen saturation of hemoglobin in musculoskeletal applications, and follows CASMED's submission of a 510(k) application.
"We are delighted to receive this expanded indication, which shows our company's commitment to expand and upgrade the quality and application of Fore-Sight for our customers," said Tom Patton, CASMED's president and CEO. "While this new application represents a modest incremental market opportunity, it may help to increase utilization as clinicians who monitor skeletal muscles also tend to monitor both hemispheres of the brain at the same time. Our new Fore-Sight Elite monitor is designed to report up to four channels of oxygenation from four sensors simultaneously in a touchscreen interface."
CASMED plans to introduce the upgraded software for the Fore-Sight Elite by the end of the third quarter.
Based in Branford, Conn., CASMED develops and manufactures medical devices for non-invasive patient monitoring. The company's Fore-Sight Absolute Cerebral oximetry technology provides accurate, non-invasive, continuous measurement of absolute cerebral tissue oxygen saturation, according to the company. In addition to Fore-Sight oximeters and accessories, the company provides a line of bedside patient vital signs monitoring products, proprietary non-invasive blood pressure monitoring solutions for OEM use, neonatal intensive care supplies, and service.
The clearance permits Fore-Sight Elite oximeters to be marketed to clinicians to determine oxygen saturation of hemoglobin in musculoskeletal applications, and follows CASMED's submission of a 510(k) application.
"We are delighted to receive this expanded indication, which shows our company's commitment to expand and upgrade the quality and application of Fore-Sight for our customers," said Tom Patton, CASMED's president and CEO. "While this new application represents a modest incremental market opportunity, it may help to increase utilization as clinicians who monitor skeletal muscles also tend to monitor both hemispheres of the brain at the same time. Our new Fore-Sight Elite monitor is designed to report up to four channels of oxygenation from four sensors simultaneously in a touchscreen interface."
CASMED plans to introduce the upgraded software for the Fore-Sight Elite by the end of the third quarter.
Based in Branford, Conn., CASMED develops and manufactures medical devices for non-invasive patient monitoring. The company's Fore-Sight Absolute Cerebral oximetry technology provides accurate, non-invasive, continuous measurement of absolute cerebral tissue oxygen saturation, according to the company. In addition to Fore-Sight oximeters and accessories, the company provides a line of bedside patient vital signs monitoring products, proprietary non-invasive blood pressure monitoring solutions for OEM use, neonatal intensive care supplies, and service.