CASMED Receives FDA Approval for Oximeter in Non-Cerebral Tissue
Plans to Introduce Upgraded Software for This New Application in the Third Quarter
CAS Medical Systems, Inc. (CASMED), a leader in medical devices for non-invasive patient monitoring, today announced receipt of U.S. Food and Drug Administration (FDA) clearance of an expanded label claim for the Company's FORE-SIGHT ELITE Oximeters for use in non-cerebral tissue of adults. This clearance will permit 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 continually expand and upgrade the quality and application of FORE-SIGHT(R) 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 an easy-to-use touchscreen interface."
CASMED plans to introduce the upgraded software that perfects these non-cerebral applications for the FORE-SIGHT ELITE in the third quarter ending September 30, 2014.