US clearance of cerebral oximeter expanded
This article was originally published in Clinica
Executive Summary
The US FDA has expanded the range of patients who can be treated with CAS Medical Systems' Fore-Sight cerebral oximeter. The extended 510(k) clearance allows Fore-Sight to be used on all patients, including newborns weighing less than 2.5kg. The device is a near infra-red spectroscopy-based device that non-invasively and continuously detects oxygen saturation changes in brain tissue, allowing clinicians to quickly react to reverse potentially harmful events before they become critical. Fore-Sight will be used to monitor smaller neonates at risk of intra-ventricular haemorrhage, central apnoea and seizures. Branford, Connecticut-based CAS gained initial FDA clearance for the device in March 2008 (see Clinica No 1297, p 22).