The US-based CAS Medical Systems (CASMED) has received the US Food and Drug Administration (FDA) 510(k) approval for its next-generation Fore-Sight Elite Absolute Tissue Oximeter.
The Fore-Sight ELITE Oximeter, which is capable of monitoring four channels of oximetry information, iscleared to provide absolute cerebral oxygenation levels in adult and transitional adolescent patients weighing 40 kilograms or more.
CASMED president and CEO Thomas Patton said that the company achieved milestones in the development of the next generation Fore-Sight Monitor and in the execution of the strategic plan with the clearance by the FDA.
"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," Patton added.
CASMED said that the Fore-Sight Elite monitor should be available to customers in the fourth quarter of 2013.
