Branford medical device maker CAS Medical Systems Inc. said regulators approved a labeling expansion for its FORE-SIGHT Cerebral Oximeter so it can be used on all patients, including infants that weigh less than 2.5 kilograms.
The device detects oxygen-saturation changes in brain tissue, “allowing clinicians to quickly react to reverse potentially harmful events before they become critical,” the company said in a statement.
The new labeling, approved by the Food and Drug Administration, will allow for monitoring of smaller newborns at risk for intra-ventricular hemorrhage, central apnea and seizures. (AP)
