A wireless foetal monitor developed by Nottingham University spin-out Monica Healthcare has been cleared for use by the US Food and Drug Administration (FDA).
The company has been granted regulatory clearance of its Monica AN24 wireless foetal monitor for use during labour and delivery. This FDA clearance enables Monica technology to be used in the US during the care of healthy women and single childbirth.
Monica AN24 collects real-time electrical signals from the abdomen of a pregnant mother. The device uses complex algorithms to identify signals related to the foetal heart rate (FHR) and contraction signals on the abdomen of singleton pregnant women using ECG-style electrodes.
This method of using electrophysiological signals is said to differ from current external monitoring devices that collect FHR and uterine activity data based on physical changes — such as changes in reflected sound waves — that may cause problems in data interpretation.
Marketed under the tradename Beacon by Monica, the wireless foetal monitoring system will be available in US hospitals through Chattanooga-based Glenveigh and promoted by Glenveigh’s sales and distribution partner Norgenix.