
Officials from CAS Medical Systems Inc. (CASMED) report receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation medical device, the FORE-SIGHT ELITE Absolute Tissue Oximeter.
"With this product clearance by the FDA, CASMED achieved major milestones in the development of our next generation FORE-SIGHT Monitor, in our quest to constantly improve our technologies, and in the overall execution of the strategic plan we adopted more than two years ago," states Thomas M. Patton, president and CEO, CASMED. "This cutting-edge product exceeds the high levels of accuracy established with our current FORE-SIGHT monitor and will further empower clinicians to protect the brain and enhance patient safety. In addition, this new monitor will afford us the opportunity to lower our cost of goods, expand distribution around the world, and provide an OEM solution to strategic partners."
The FORE-SIGHT ELITE Oximeter was cleared to provide absolute cerebral oxygenation levels in adult and transitional adolescent patients weighing 40kg or more. Among other advanced features, the ELITE Oximeter is capable of monitoring four channels of oximetry information, is portable, has a large high-contrast viewing screen, and has touch screen controls to enhance operability.
The FORE-SIGHT Elite monitor should be widely available to customers in the fourth quarter of 2013.
"We continue to invest in development efforts to provide best-in-class products to our customers," Patton continues. "With FORE-SIGHT ELITE, we will once again re-set our own standard for actionable accuracy as we work to enhance our growth rates and expand the overall market for cerebral oximetry."
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