US Approval For Foetal Monitor

A ground breaking wireless foetal monitor developed by a University of Nottingham spin out company, has been cleared for use in America by the US Food and Drug Administration (FDA). Monica Healthcare hopes that its technology will lead to improved patient care, raise efficiency, and ultimately reduce the cost of pregnancy care in the hospital. Company CEO Carl Barratt said that the introduction of the monitor to the US market “is a significant milestone for Monica Healthcare, an endorsement of the team here, and represents an exciting opportunity for this advanced technology to positively impact the care of pregnant women during the critical stages of labour.” Using wireless, non-invasive technology to collect real-time electrical signals from the abdomen of a pregnant mother, the device uses complex algorithms to correctly 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 differs from current external monitoring devices that collect FHR and uterine activity data based on physical changes (e.g. change in reflected sound waves and changes on strain gauge) that may cause problems in data interpretation. The monitor is simple to use, beltless, requires no wires to connect to the display or printer, and will provide high levels of patient satisfaction. There is
also no need for the constant re-positioning of transducers, which is required with the current technology, especially during an epidural when the patient is on her side.The monitor will be available in the USA through Glenveigh Medical.