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US approval for ground breaking wireless fetal monitor

   
   
  Monica-monitor-pr
17 Feb 2011 15:42:09.963

PA 54/11

A ground breaking wireless fetal monitor developed by Monica Healthcare, a University of Nottingham spin out company, has been cleared for use in America by the US Food and Drug Administration (FDA).

The company has been granted regulatory clearance of their Monica AN24 wireless fetal monitor for use during labour and delivery. This FDA clearance enables Monica technology to be used in the USA during the care of healthy women and single childbirth.

Monica hopes that its technology will lead to improved patient care, raise efficiency, and ultimately reduce the cost of pregnancy care in the hospital. Carl Barratt, CEO of Monica Healthcare, said: “The introduction of Monica AN24 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.” 
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The Monica AN24 uses innovative 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 fetal 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. 

Clinical trials in the US also have demonstrated that the monitor also performs well in obese women.  Professor W Cohen from Albert Einstein College of Medicine, New York, said: “We found the Monica AN24 performed excellently in very obese women when compared with available Doppler ultrasound/tocodynamometer techniques.”  Obesity in pregnancy is becoming more prevalent and acquiring accurate FHR and uterine activity signals in obese patients using conventional external monitoring is sometimes challenging.

In the hospital, the Monica AN24 will be available exclusively in the USA through Glenveigh Medical. 

For more information on Monica Healthcare go to: www.monicahealthcare.com, or contact info@monicahealthcare.com.  In the USA contact Glenveigh Medical www.glenveigh.com, or Norgenix www.norgenixpharma.com.


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Notes to editors: The University of Nottingham, described by The Sunday Times University Guide 2011 as ‘the embodiment of the modern international university’, has award-winning campuses in the United Kingdom, China and Malaysia. It is ranked in the UK's Top 10 and the World's Top 75 universities by the Shanghai Jiao Tong (SJTU) and the QS World University Rankings. It was named ‘Europe’s greenest university’ in the UI GreenMetric World University Ranking, a league table of the world’s most environmentally-friendly higher education institutions, which ranked Nottingham second in the world overall.

The University is committed to providing a truly international education for its 40,000 students, producing world-leading research and benefiting the communities around its campuses in the UK and Asia.

More than 90 per cent of research at The University of Nottingham is of international quality, according to the most recent Research Assessment Exercise, with almost 60 per cent of all research defined as ‘world-leading’ or ‘internationally excellent’. Research Fortnight analysis of RAE 2008 ranked the University 7th in the UK by research power. The University’s vision is to be recognised around the world for its signature contributions, especially in global food security, energy & sustainability, and health.

More news from the University at: www.nottingham.ac.uk/news

Story credits

More information is available from Dr Bruce Venning on +44 (0) 115 846 7891, bruce.venning@nottingham.ac.uk; or Dr Barrie Hayes-Gill, Department of Electrical and Electronic Engineering, University of Nottingham, on +44 (0)115 951 5547, Barrie.hayes-gill@nottingham.ac.uk
Lindsay Brooke

Lindsay Brooke - Media Relations Manager

Email: lindsay.brooke@nottingham.ac.uk Phone: +44 (0)115 951 5751 Location: University Park

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