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CASMED Receives FDA Approval for FORE-SIGHT ELITE in Pediatric and Neonatal Patients

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CAS Medical Systems, Inc. (Nasdaq: CASM) (CASMED), a leader in medical devices for non-invasive patient monitoring, announces receipt of an expanded label for its FORE-SIGHT® ELITE oximeters from the U.S. Food and Drug Administration (FDA) to include its new medium and small sensors for use with pediatric and neonatal patients.

"The approval of the FORE-SIGHT ELITE in this patient population came somewhat earlier than we had expected, and allows us to complete our product offering while opening new opportunities both in the U.S. and around the world," said Thomas M. Patton, President and Chief Executive Officer of CASMED. "With the launch of the FORE-SIGHT ELITE for pediatric and neonatal patients, we will have the ability to address additional sales channels and call points within a hospital with the exact same monitor. We are on track to introduce the FORE-SIGHT ELITE in this market segment in the late third or early fourth quarter of this year.

"We based our regulatory filing on a significant number of clinical evaluations of pediatric patients conducted at multiple sites around the world, including some of the nation's leading children's hospitals. Feedback on the performance of the FORE-SIGHT ELITE from these sites was overwhelmingly positive," added Mr. Patton.

CASMED also announces that it sponsored a lunch symposium at the 37th Society for Cardiac Anesthesia Annual Meeting & Workshops held earlier this week in Washington, D.C. The hour-long symposium featured a panel of leading physicians discussing the clinical benefits of monitoring cerebral oxygenation in a broad variety of cardiac surgeries through the use of case studies, personal experience and the latest clinical evidence.

"We are delighted that more than 200 cardiac anesthesiologists joined us for this standing-room-only discussion," added Mr. Patton. "Cerebral oxygenation is a major concern during cardiac surgery, and we were able to showcase the patient benefits of monitoring with our FORE-SIGHT ELITE oximetry to anesthesiologists who are the target customers for our product."

 

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