07.13.15
CAS Medical Systems Inc.’s Fore-Sight Elite oximeter has won an expanded U.S. Food and Drug Administration (FDA) indication for pediatric and neonatal patients. The company plans to launch the device for these patients in the third or fourth quarter of the year.
"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/CEO of CAS Medical Systems (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."
The Fore-Sight Elite noninvasively and continuously measures absolute cerebral tissue oxygenation and is the only FDA-cleared tissue oximeter equipped with a fifth wavelength of near-infrared light to decrease patient variability, the company claims. The oximeter does away with the need for pre-induction baseline readings.
"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," Patton added.
Tissue oxygen saturation monitoring allows health professionals to treat otherwise undetected and dangerous low oxygen levels in the brain and other tissues.
Based in Branford, Conn., CASMED develops and manufactures non-invasive patient monitoring devices. The company's Fore-Sight Absolute Cerebral oximeter provides an accurate, non-invasive, continuous measurement of absolute cerebral tissue oxygen saturation. In addition to Fore-Sight oximeters and accessories, the company provides a line of bedside patient vital signs monitoring products, proprietary non-invasive blood pressure monitoring solutions for OEM use, neonatal intensive care supplies, and service.
"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/CEO of CAS Medical Systems (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."
The Fore-Sight Elite noninvasively and continuously measures absolute cerebral tissue oxygenation and is the only FDA-cleared tissue oximeter equipped with a fifth wavelength of near-infrared light to decrease patient variability, the company claims. The oximeter does away with the need for pre-induction baseline readings.
"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," Patton added.
Tissue oxygen saturation monitoring allows health professionals to treat otherwise undetected and dangerous low oxygen levels in the brain and other tissues.
Based in Branford, Conn., CASMED develops and manufactures non-invasive patient monitoring devices. The company's Fore-Sight Absolute Cerebral oximeter provides an accurate, non-invasive, continuous measurement of absolute cerebral tissue oxygen saturation. In addition to Fore-Sight oximeters and accessories, the company provides a line of bedside patient vital signs monitoring products, proprietary non-invasive blood pressure monitoring solutions for OEM use, neonatal intensive care supplies, and service.