FDA Expands Indication for CAS Medical Systems’ Fore-Sight Elite
CAS Medical Systems’ Fore-Sight Elite oximeter has won an expanded FDA indication for pediatric and neonatal patients, the Branford, Conn., devicemaker announced Wednesday. The company plans to launch the device for these patients in the third or fourth quarter of the year.
The Fore-Sight Elite noninvasively and continuously measures absolute cerebral tissue oxygenation and is the only FDA-cleared tissue oximeter equipped with a 5th wavelength of near-infrared light to decrease patient variability, the company claims. The oximeter does away with the need for pre-induction baseline readings.
Tissue oxygen saturation monitoring allows health professionals to treat otherwise undetected and dangerous low oxygen levels in the brain and other tissues. — Jason Scott