The US Food and Drug Administration (FDA) has granted 510(k) clearance for the Dawes-Redman CTG Analysis, enabling its use in electronic foetal monitoring across the country.
The approval allows clinicians to utilise the system in assessing non-stress test (NST) traces to support foetal wellbeing evaluations.
Developed by researchers at the University of Oxford, the Dawes-Redman CTG Analysis determines whether an NST trace meets specific criteria for normality. The system evaluates multiple parameters, including basal heart rate, sinusoidal rhythms, and short-term variation (STV) in foetal heart rate, a metric that cannot be manually calculated.
The analysis is based on a dataset of over 100,000 traces and has been refined over the past four decades. Research has shown its effectiveness in identifying foetal wellbeing, with high specificity supported by more than 125 peer-reviewed studies.
The algorithm, originally created by Geoffrey Dawes and Chris Redman at University of Oxford, has undergone continuous development.
The Dawes-Redman CTG Analysis is exclusively integrated into Huntleigh Healthcare’s Sonicaid TEAM3 series of foetal monitors and the OBIX BeCA foetal monitor, which is distributed in the US by Clinical Computer Systems.
Further enhancements to the system by the University of Oxford team are said to have reduced the time required to assess a healthy trace to approximately 10 minutes. This is significantly less than the 30 minutes or more typically needed for manual interpretation.
Huntleigh Healthcare managing director Gang Zhang said: “Introducing the Dawes Redman analysis to the US marks a significant milestone, leading the way for a standardised and modernised maternity care approach. This objective assessment empowers clinicians to uncover the invisible insights, offering reassurance and clarity during critical moments.”
Huntleigh Healthcare, a UK-based medical technology manufacturer and a subsidiary of Arjo, holds exclusive distribution rights for the Dawes-Redman CTG Analysis. The company specialises in developing medical equipment for healthcare professionals worldwide.
