FDA Clears Next Generation Of FORE-SIGHT® Absolute Tissue Oximeter

In short

Patient monitoring device company CAS Medical Systems, Inc., has received U.S. FDA 510(k) clearance for its next-generation FORE-SIGHT ELITE™ Absolute Tissue Oximeter.

Background

Direct monitoring of tissue oxygenation provides a powerful tool to alert clinicians to otherwise unrecognized and dangerously low levels of oxygenation of the brain and other tissues, thereby allowing them to intervene appropriately in the care of their patients.

The FORE-SIGHT ELITE Oximeter is indicated to provide absolute cerebral oxygenation levels in adult and transitional adolescent patients weighing 40 kilograms 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.

Clinical study data shows the FORE-SIGHT ELITE Oximeter is more accurate than the current FORE-SIGHT Oximeter, which already has an unparalleled level of accuracy for commercially available tissue oximeters.

CAS Medical Systems plans for its new monitor to be widely available to customers in the fourth quarter of 2013.

Company comments

“With this product clearance by the FDA, CAS 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,” said Thomas M. Patton, President and Chief Executive Officer of the company.

“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.”

“We continue to invest in development efforts to provide best-in-class products to our customers,” Mr. Patton continued. “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.”

Source: CAS Medical Systems, Inc., Globe Newswire