US clearance of cerebral oximeter expanded
This article was originally published in Clinica
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).